Healthy Skepticism Library item: 10489

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Medecines in Europe Forum (MIEF)
Fact Sheet on Health Information: Patient information driven by pharmaceutical companies - the aim is to boost sales
: Medecines in Europe Forum (MIEF) 2007 May

Full text:

Pharmaceutical companies are seeking greater influence over the general public so as to create and expand demand for medicines.They are using a variety of strategies which are becoming more and more insidious.

Since the 1990s, healthcare has increasingly been treated as a commodity and the pharmaceutical market has become increasingly globalised. There are more and more ‘blockbuster drugs’, achieving sales worth several billion dollars, and this has made pharmaceutical companies more attractive than ever to investors. But the euphoria of the 1990s and the early twenty-first century has now given way to a tougher period, with patents on blockbuster drugs expiring and fewer promising new products in the pipeline, either in terms of fulfilment of real public health needs or achievement of blockbuster sales.

Faced with these difficulties, pharmaceutical companies have devised a range of commercial strategies, one of which is to advertise their products – including prescription drugs – directly to the public in various ways (1).

The public is key to the market

Direct-to-consumer advertising is advantageous to the pharmaceutical companies in several ways: patients are not as well educated as health professionals about health or drugs; people who are ill are more vulnerable and their desire for a cure may make them less critical; they are often ready to try anything and can easily be persuaded that newer drugs are better; they can convince doctors to prescribe a drug which they have heard about via the media; they are a particularly good target for pharmaceutical companies seeking to expand the pharmaceutical market by creating new ‘needs’ and medicalising various aspects of human existence. The experience in the USA demonstrates that direct-to-consumer advertising of prescription drugs plays on patients’ anxieties, fosters exaggerated hopes and prompts them to ask their doctors for drugs which are not the most appropriate for them (2,3).

At present, pharmaceutical companies are diverting a growing share of their marketing budget away from health professionals and towards consumers; there is more than 4 billion dollars worth of consumer advertising a year in the USA (4). The pharmaceutical industry is lobbying intensively to obtain the right to communicate directly to consumers in all countries.

Many forms of direct-to-consumer advertising

Pharmaceutical companies have already developed many different means of reaching the public directly, in some cases in ways that are more insidious than clearly identifiable direct advertising.

Disease-awareness campaigns.
“Information” on illnesses and health conditions distributed by pharmaceutical companies, with no mention of a drug name, is allowed in Europe and is not considered to be advertising. But when a pharmaceutical company provides information on a disease advising people to “discuss it with their GP”, there is no need for the drug to be mentioned by name for the GP to realise which medicine is being discussed when the patient asks about treatments (5).

To claim that disease-awareness campaigns and advertising are separate is naive, even hypocritical. In practice, pharmaceutical companies provide information on illnesses and health conditions only if they have a drug available for those conditions. Drug companies are highly unlikely to tell patients that the problem might clear up on its own, or that non-drug approaches are effective for prevention or treatment, or that a competitor’s drug is the first-line treatment.

Disease mongering.
The boundary between disease-awareness campaigns and disease-mongering, in which companies create new illnesses for the drugs they market, is often blurred. Companies do not exactly invent illnesses out of nothing. Instead, they often lump together real and sometimes disparate symptoms, naming a new creation and declaring it to be a serious health problem for which drug treatment is offered. They may also artificially widen the boundaries of treatable illness to include a larger group of people as needing treatment. Another approach is to medicalise the ups and downs of daily life and redefine them as “pathological” (5).

“Information” from pharmaceutical companies often supports the idea that many people who are ill are unaware of their condition, and that a drug treatment exists for every problem, thus opening up pharmaceutical markets to fulfil patient “needs” and “demand” (6 to 10).

For example, in 1999, Lilly succeeded in obtaining approval from the US Food and Drug Administration for fluoxetine (Prozac) for “premenstrual dysphoric disorder”, a new indication corresponding to mood swings in premenstrual women. Thus far, the European Medicines Agency (EMEA) has refused this indication on the grounds that it is not an established diagnosis.

More recently Sanofi Aventis has promoted rimonabant (Acomplia) as helping to combat “metabolic syndrome”. “Metabolic syndrome” is an umbrella term encompassing several loosely related disorders, which often include obesity, high cholesterol levels (dyslipidaemia), impaired glucose metabolism (particularly type 2 diabetes) and high blood pressure. “Metabolic syndrome” is defined according to different lists of criteria in different countries. The large disparities between these lists emphasises the artificial nature of this syndrome. In practice, there is no value in diagnosing “metabolic syndrome” as there is no specific treatment with demonstrated clinical effectiveness.

Fabrication of medical news stories.
Pharmaceutical companies start preparing for the launch of their new products earlier and earlier. New medicines are trumpeted years in advance by the consumer press, which is constantly on the lookout for headline-making medical news. This was the case with the Cox-2 inhibitors, the non-steroidal anti-inflammatory drugs celecoxib (Celebrex) and rofecoxib (Vioxx), and rimonabant (Acomplia), which was promoted initially by the manufacturer as being effective against obesity and nicotine addiction, then against metabolic syndrome, and finally indicated at best solely for some obese and diabetic patients.

Another example is, varenicline (Champix) a drug to help smokers to quit. This initial medicinal product promotion often takes the form of a campaign to raise journalists’ and consumers’ awareness of health problems “that are undertreated”, or “mistakenly considered to be trivial or unimportant”, or are becoming “increasingly common”. The drugs being developed are often presented uncritically by the consumer press as “a major breakthrough”, “a revolutionary innovation” or even a “miracle drug”. Several studies have revealed the deceptive nature of most of these drug news stories” (11,12).

“Key opinion leaders” – health professionals with undisclosed or even knowingly concealed connections to the pharmaceutical companies – often take part in these pre-launch drug campaigns (13).

“Support” for patient groups.
Pharmaceutical companies now involve patient groups in their commercial strategies. This sometimes extends to setting up patient groups hemselves. One such example is the “National Alliance for the mentally ill” founded up by Lilly in the USA, and another is the organisation “Action for access”, created by Biogen in the UK (14). The pharmaceutical industry is also aware that many policies are defined at an international level and also supports transnational associations or federations such as the International Alliance of Patients’ Organizations (IAPO) and the European Patients’ Forum (15,16). It is regrettable that the European Commission often chooses to consult such organisations as patient representatives under the pretext that they are international or pan-European (15).

A study published in the New Scientist in October 2006 revealed that in 2005 the US Restless Legs Syndrome Foundation received US $ 450,000 from GSK, which sells ropinirol (Adartrel), and US $ 178,000 dollars from Boehringer Ingelheim, marketing pramipexol (Sifrol). Both drugs are treatments for restless legs syndrome. The hidden agenda behind these donations is highlighted even further by the fact that Pfizer, which was one of the Foundation’s major donors in 2003 and 2004, stopped contributing in 2005 after abandoning the development of a drug to treat “restless leg syndrome” (17).

In providing these organisations with “information” and funding, pharmaceutical companies turn them into allies and advocates vis-à-vis patients and health authorities. Patient groups prove useful to the companies when governments balk at a drug’s high cost or refuse reimbursement, for example (15,18).

“Compliance support programmes”.
The aim of direct-to-consumer advertising of prescription drugs is not only to convince a new patient to become a new “customer”, but also to help build “customer” loyalty. The annual cost per patient of long-term treatment sometimes represents a large sum of money. If patients interrupt or discontinue treatments, manufacturers stand to lose money.

Marketing experts have estimated that the pharmaceutical industry could lose US $ 30 billion of sales a year through patient ‘non-compliance’. They recommend that manufacturers set up “compliance support programmes” for their treatments (19,20).

It is clear from the professional pharmaceutical marketing literature that these compliance support programmes are designed as customer loyalty advertising campaigns (21,22).

“Risk minimisation”.
As with compliance support programmes, unless we are vigilant, pharmaceutical companies could soon have the opportunity to provide patients with information directly in the guise of “risk management plans” currently being introduced in the Guidelines implementing Directive 2004/27/EC. These risk management plans attempt to mitigate the disadvantages of increasingly premature market approvals (23). Here too, as with the “compliance support programmes”, it is hard to see how manufacturers, with their innate conflicts of interest, are going to be able to help patients to respond to potential adverse effects in a way that is either credible or that is in patients’ best interests. The recent case of Zyprexa (olanzapine), which is indicated to treat schizophrenia, highlights the problem. Lilly is accused of having concealed unfavourable evidence concerning adverse effects of olanzapine. This example illustrates how tempting it is for pharmaceutical companies to keep potentially damaging information on the adverse effects of their drugs to themselves (24).

Illusory self regulation

The possibility that information supplied to the public by drug manufacturers can be effectively regulated through codes of practice or monitored by governments is unrealistic.

The “Code of conduct” drawn up by the pharmaceutical industry in the USA to try to prevent the introduction of tighter controls and even a ban on direct-to-consumer advertising for prescription drugs has proved to be a smokescreen (25). And the experience of recent years shows that regulatory authorities often respond too slowly to advertising and promotional abuses. A study by the US Government accountability office (GAO) has shown that the Food and Drug Administration (FDA) is unable effectively to regulate direct-to-consumer advertising (4,26). Repeat violations were common and on average advertisements continued to run for 4 months after the FDA had found them to be in violation of US law.

The priority today should not for pharmaceutical companies be to advertise directly to patients, but to improve significantly the patient information leaflets that accompany their drugs. And the priority for drug regulatory authorities should not be to permit the pharmaceutical industry to provide ‘information’ to the public, but to improve transparency of regulatory decisions and to squarely put the patient and public health at the centre of decisionmaking. And if governments want to be truly useful in the area of patient information, they can support independent sources of information and patient groups which are independent of the pharmaceutical industry (4,14).

The Medicines in Europe Forum

Extracts from the literature search.
1- Medawar C “The politics of direct-to-consumer promotion of prescription medicines”. In “Providing prescription medicine to consumers: is there a role for direct-to-consumer promotion?” Website http://www.haiweb.org accessed 4 April 2007:3 pages.
2- Mansfield P “There’s a better way than DTCA”. In: “What are the public health effects of direct-to-consumer drug advertising?” PLoS Medicine 2006; 3(3): 274-287.
3- Prescrire Rédaction “La publicité directe au public: la désastreuse expérience américaine” Rev Prescrire 2002; 22 (232): 703-706.
4- “The direct-to-consumer advertising genie” Lancet 2007; 369: 1.
5- Mintzes B “An ill for every pill” ISDB Newsletter 2006; 20 (2): 17-19.
6- Prescrire Rédaction “Fabriquer des maladies pour vendre des médicaments” Rev Prescrire 2007; 27(279): 63-65.
7- Mintzes B “Fabriquer des maladies pour vendre des médicaments” Rev Prescrire 2007; 27 (279): 63-65.
8- Prescrire Rédaction “Façonner des maladies: l’emprise du marketing” Rev Prescrire 2007; 27(283): 381-382.
9- “A collection of articles on disease mongering” Website: http://collections.plos.org/plosmedicine/diseasemongering-2006.php.
10- Parry V “The art of branding a condition” Medical Marketing & Media 2003; May issue: 43-49.
11- Prescrire Rédaction “Trop de “scoops” médicaux sans valeur” Rev Prescrire 2004; 24 (248): 223.
12- Prescrire Rédaction “Gare aux “scoops” sur les innovations médicales” Rev Prescrire 2004; 24 (256): 857-858.
13- Prescrire Editorial Staff “Opinion leaders: expensive but cost-effective for drug companies” Prescrire Int 2006; 15 (81): 31.
14- Herxheimer A “Relationships between the pharmaceutical industry and patients’ organisations” BMJ 2003; 326: 1208-1210.
15- Prescrire Editorial Staff “Dangerous liaisons: patient groups and drug companies” Prescrire Int 2005; 14 (77): 111-112.
16- Patient View “European patients’ group. Directory 2007”: 158 pages.
17- Marshall J and Aldhous P “Patient groups special: swallowing the best advice?” New Scientist 2006; 27 October issue: 4 pages.
18- Buckley J “Pharmaceutical marketing. Time for change” Electronic Journal of Business Ethics and Organization Studies; 9 (2): 4-11.
19- Prescrire Editorial Staff “Compliance support programmes: a Trojan horse” Prescrire Int 2006; 15(83): 114.
20- Prescrire Editorial Staff “BigPharma’s medication compliance programmes: just say no!” Prescrire Int 2007; 16 (87): 32.
21- Smith D “DTC’s new job: boosting compliance” Website http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=73307 accessed 6 April 2007: 9 pages.
22-Wosinska M “Advertising to acquire or retain?” Website http://www.dtcperspectives.com/content. asp?id=161 accessed 6 April 2007: 3 pages.
23- Prescrire Rédaction “Plans de gestion des risques: pas rassurants du tout” Rev Prescrire 2007; 27 (282): 259-260.
24- Berenson A “Eli Lilly said to play down risk of top pill” New York Times 17 December 2006. Website http://www.nytimes.com accessed 26 April 2007: 5 pages.
25- Prescrire Rédaction “La publicité grand public pour les medicaments de prescription: abus et confusion” Rev Prescrire 2006; 26 (277): 777-778.
26- GAO “Prescription drugs: improvements needed in FDA’s oversight of direct-to-consumer advertising”. Website http://www.gao.gov accessed 6 April 2007: 52 pages.

Further reading…
For more in-depth articles on direct-to-consumer advertising (DTCA), here are a few additional references.
• Brown H “Sweetening the pill – Can big pharma be trusted to provide independent health information to patients?” BMJ 2007; 334: 664-666.
• Frosch D et al. “Creating a demand for prescription drugs: a content analysis of television direct-to-consumer advertising” Annals of Family Medicine 2007; 5 (1): 6-13.
• Mansfield P “There’s a better way than DTCA”. In: “What are the public health effects of direct-to-consumer drug advertising?” Plos Medicine 2006; 3 (3): 777-778.
• Gilbody S and coll. “Benefits and harms of direct to consumer advertising: a systematic review” Qual Saf Health Care 2005; 14: 246 – 250.
• Kravitz et al. “Influence of patients requests for direct-to-consumer advertised antidepressants: a randomized controlled trial” JAMA 2005; 293: 1995-2002.
• Mintzes B et al. “How does direct-to-consumer advertising (DTCA) affect prescribing?
A survey in primary care environnements with and without legal DTCA” CMAJ 2003; 169 (5): 405-412.
• Consumer International “Branding the Cure – A consumer perspective on Corporate Social Responsibility, Drug Promotion and the Pharmaceutical Industry in Europe” June 2006: 51 pages (downloadable from www.consumersinternational.org).
• Toop et al. “Direct-to-consumer advertising of prescription medicines in New Zealand. Submission on DTCA Health Ministery consultation from the academic departments of general practice and primary care throughout New Zealand”. University of Otago. April 2006: 159 pages.
• NJPIRG Law and Policy Center “Turning medicine into snake oil – How pharmaceutical marketers put patients at risk” May 2006: 52 pages (downloadable from Federation of the U.S. Public Interest Research Groups’ website: www.uspirg.org).
• Blech J “The disease inventors: how we are turned into patients” (translated from “Die Krankkeitsfinder: wie wir zu Patienten gemacht werden” 2003).