Science Focus Vol. 18 (1) 2013 pp 57 - 62 Faculty of Pure and Applied Sciences, LAUTECH, Printed in Nigeria ANTIPLASMODIA EFFICACY OF METHANOLIC EXTRACT OF LEAF OF MORINDA LUCIDA Tajudeen O. OSENI and *Kuranga I. AYINLA Department of Chemistry, Institute of Basic and Applied Sciences, Kwara State Polytechnic, P.M. B. 1375, Ilorin- Nigeria. Abstract Methanolic leaf extract o
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Ejbo_vol9_no2.inddEJBO Electronic Journal of Business Ethics and Organization Studies Introduction
equal relationship with their physicians. This paper reviews current marketing On the other hand action groups such as Abstract
practices in the pharmaceutical sector, the U.S. Public Citizen’s Health Research oriented promotion. It presents examples tend that there is no evidence that such of marketing practices and their impact advertising improves health care. identiﬁes negative impacts of these prac- area to engage with, given that Big Phar- ing, disease mongering and escalating ing example. They engage in multi-mil- costs. It goes on to argue the need for an lion dollar marketing campaigns, use all tice for marketers in the pharmaceutical advertising, to below the line spend on sector and a greater degree of consumer measures such as the engagement of key education for both end-users and those opinion leaders. Many billions of dollars tecting not alone their branded products The context
Pharmaceutical marketing methods,
How are drugs promoted?
entitled“time to untangle doctors from a so-called block-buster drug is current- drug companies”(Moynihan 2003). The ly estimated at $895 million (EFPIA, theme was relationship between the 2002). Obviously ﬁrms who spend that kind of money need to recoup their costs. cal profession in Europe, in conjunction that Big Pharma under pressure. It needs with many social movements, has begun to expand sales of blockbuster drugs since there are fewer drugs in pipeline. In ness of current relationships between order to sustain current levels of growth, Big Pharma and the health sector. This ﬁrms would need to introduce one new is occurring in the context of legal actions product each year that would sell $4.9 around corrupt sales practices in Europe million for each 1 to 1.5 per cent it has such as those against GlaxoSmithKline of the world pharmaceutical market. “A aly (Turone 2003), and the major action Glaxo Wellcome/Smith KlineBeecham against TAP Pharmaceutical Products, needs three to seven products each year, Inc in the United States which resulted in while one the size of Astra Zeneca needs a $875 million dollar settlement in 2001 two to four products each year. The prob- lem is that research productivity is fail- This debate is already very strong in ing. None of the major companies is close the United States where it has further to the target.” (Horrobin 2000) between Big Pharma and consumers. the nature of the marketing mission is This is in part because of US practice of diﬀerent. There are essentially two cat- allowing direct- to-consumer advertising egories of drugs: self-medication or over (DTCA) of prescription drugs. Industry the counter (OTC) drugs, and prescrip- tion drugs - sometimes referred to as eth- tical industry argue that such advertising 1997). OTC drugs are promoted directly (properly regulated) allows consumers to consumers as well as physicians and to inform and educate themselves about other healthcare professionals and range EJBO Electronic Journal of Business Ethics and Organization Studies from analgesics such as paracetamol to anti-histamines. What broadcast DTCA of these drugs has resulted in increased “pull” is categorized as OTC varies from country to country and is de- from consumers. In both the United States and New Zealand pendent on the local legislative framework – usually a national DTCA of prescription drugs occurs with considerable eﬀect, as medicines authority, so for example in the United States some will be discussed below. A further source of ‘indirect’ pull has been the impact of the Internet on pharmaceutical promotion, Corstjens (1991) identiﬁes four main buying parties for pre- 1. Prescriber – prescribing rights vary internationally and this category may include doctors, dentists, pharmacists, nurses Direct to consumer promotion –
creating direct pull
2. Inﬂuencer – hospitals, nurses, professors, reimburse- In August 1997 the US FDA made signiﬁcant changes in the regulations for broadcast DTCA of prescription drugs. Prior to 4. Financier – partly patient, partly government or third 1997 DTCA had to include the entire brief prescribing infor- party (varies by country), managed health care organization mation which meant that about 30 seconds out of a 60 second (hospitals, Health Maintenance Organisations etc.) advertisement would consist of ﬁne print scrolling across the The majority of Big Pharma’s marketing budget is targeted screen. In 1997 the FDA dropped this requirement and said that at doctors and others with prescribing power, who are eﬀective- DTCA had to mention the major side-eﬀects, and also provide ly the gatekeepers to drug sales. In 2002 the Canadian Medi- other ways that consumers could get more information about cal Association Journal estimated some US$19 billion is spent the drug (e.g. give a web site, a 1-800 number or refer to a print by Big Pharma annually in promoting drugs to doctors in the ad for the same product which contained the same information) United States alone. The methods used will be discussed later and tell consumers to consult their doctors/pharmacists. In the four-year period from 1996 to 2000 promotional spend direct In the European Union only OTC drugs are promoted di- to consumer within the United States tripled (from $791 mil- rectly to consumers. Examples include analgesic preparations lion dollars to $2.5 billion dollars, New England Medical Jour- and some ailment-speciﬁc drugs such as the Schering Plough nal 14/2/02). New Zealand is the only other developed coun- blockbuster Clarityn - a hayfever remedy. In 1998 Schering try that allows DTCA of prescription drugs. Burton (2003) Plough spent $186 million promoting Clarityn, and as a result details a report by academics from all of New Zealand’s medical saw a half a billion dollar increase in sales year on year to achieve schools which recommended that the practice be discontinued. annual sales of $1.9 billion, (Maguire 1999).
This report, based on a survey of all general practitioner doctors In the United States all drugs may be promoted to consum- in New Zealand, found that seventy ﬁve per cent of respondents ers, but in practice direct to consumer advertising focuses on believed DTCA to be negative with patients frequently request- OTC and common-ailment targeted prescription drugs. There ing drugs that were inappropriate to them. On the other hand are other more limited application drugs for less common dis- in New Zealand drug advertising is not monitored by a state eases that are only promoted to health care professionals, and agency (whereas it is in the United States). The pharmaceu- hospital and organizational formulary committees (such as tical and advertising industries are self-regulating. This leads HMO formulary committees). The drug marketing process to a less than ideal situation where only a small percentage of can be described by the model below in Figure 1, which shows the televised pharmaceutical advertisements are compliant with the information ﬂow from drug companies, both to consumers the New Zealand Medicines Act regulations, which ostensibly and doctors. It also shows the power that consumers, informed control for information on contra-indications, and safety and by DTCA and the Internet, have in “pulling” prescription drugs quality of medicines (pharmacovigilance).
Effects of DTCA on consumers
Flynn (1999) argues that DTCA makes consumers better informed and more sophisticated. In his view consumers are enabled, through DTCA, to better understand the market for drugs and the therapeutic options available to them. This view is also shared by Calfee (2002), who argues that consumers can engage in more equitable relationships with health care provid- ers and become partners in their own health care as a result of DTCA. Mintzes et al (2002) found that consumers pulled prescription drugs through the system, going to physicians with Figure 1. Pharmaceutical marketing process.
requests for medications that they had learnt of through adver- tisements. Their research showed that patients normally got Creating the Pull – Directly and Indirectly:
positive responses to requests for prescriptions. Their research also showed that physicians were inﬂuenced in their choice of Historically promotion for prescription drugs occurred only drugs and might otherwise have prescribed diﬀerent drugs. from manufacturer to prescriber so that physicians and oth- Maguire (1999) likewise suggests that American physicians ers with prescribing powers were the gatekeepers to eventual are being asked to ‘rubber stamp’ self-diagnoses and self-pre- drug sales. The promotion strategies therefore were all essen- scriptions by patients. Citing a study by Prevention magazine tially “push” focused. However the decision in 1997 by the US of the previous year she suggests that 15.1 million U.S. consum- Food and Drugs Administration (FDA) to relax restrictions on ers asked their physician for a medication they saw advertised, EJBO Electronic Journal of Business Ethics and Organization Studies and that physicians honoured those requests eighty percent of The United Kingdom Medicines Control Agency subsequently the time, which translates into 12.1 million prescriptions gen- stopped this initiative citing it as unlawful promotion. However erated by advertising. Further evidence of the eﬀectiveness of Herxheimer (2003) points out that in the absence of adequate DTCA is the fact that visits to doctors for conditions covered in independent funding patients organisations and lobbying advertising campaigns rose 263 per cent in the ﬁrst nine months groups are likely to continue to accept funding from pharmaceu- of 1998, in comparison to a general 2 per cent rise in visits to tical companies despite the clear ethical issues. He gives as ex- doctors. Lexchin and Mintzes (2002) examining the relation- amples the International Alliance of Patient Organisations and ship between DTCA and prescribing practices ﬁnd that DTCA the Global Alliance of Mental Health Illness Advocacy which does aﬀect doctors’ prescribing patterns, which they suggest are both highly visible and linked ﬁnancially to Big Pharma.
is not always a positive development. They give as an example Medawar (2002) quotes the Chairman of the Danish Mi- General Motors’ 1999 internal study of the prescription of the graine Association who suggests that patient organizations are gastrointestinal drug Prilosec (the second most heavily DTC becoming more sophisticated in their interactions with Big promoted drug in 1999) to its employees. GM found that 92% Pharma and may become hardened to this form of below the of those who received a prescription for Prilosec had not received line promotion. The chairman tells of the association’s experi- a previous prescription or even consulted a doctor previously ences when it refused to take industry assistance in its activities for gastrointestinal problems. Most received Prilosec as a ﬁrst – magazines, lectures and administration. “the industry, gen- line drug without ﬁrst trying other cheaper and less intensive erally assisted by the research doctors, literally created a new treatments. Lexchin and Mintzes argue that this is evidence that patient organization as a substitute for the Migraine Associa- DTC has impacted on prescribing patterns, eﬀectively creating tion in 1996. This was a bit too blatant to be generally accepted consumer pull for in some cases inappropriate therapies. among informed patients and opinion makers, but only because we did not accept the situation gracefully and made the press aware of our situation. …. Luckily we have a growing awareness Creating pull indirectly
Medawar points out that Big Pharma have been successful Increasingly consumer pull for drugs is being created indi- in presenting their concerns to reach consumers directly as a rectly also by Internet promotion, and perhaps more question- consumer rights issue, and a potential positive contribution to ably by partnerships with patient support groups. national health proﬁles. He suggests that Big Pharma is “gradu- ally shifting the core of its business away from the unpredictable Consumers are able to purchase all kinds of prescription and increasingly expensive task of creating drugs and toward the drugs online often without need for a prior prescription. Re- search conducted by Bloom (1999) showed that most Internet pharmacies provide poor quality information, fail to have ad- equate safeguards to ensure medicines are dispensed correctly, The Push Strategy: Promotion to Physicians and
and also charge more for both products and services. Smith health-care professionals
(2003), referring to an Australian study, found that online pharmacies often lacked important information about contra- “Despite the boom in consumer ads, doctors are still king” indications for medications available on their sites. However Maguire (1999) even if one sets aside the impact of Internet pharmacies, on the However enormous the implications of DTCA of drugs basis that the additional costs may put them outside the reach and the budgets devoted to this, the issue of physician targeted of consumer, the Internet has also oﬀered Big Pharma a largely promotion is signiﬁcantly greater on all fronts, both ﬁnancially unregulated way to reach the consumer directly – through com- and in terms of eventual outcomes. Komesaroﬀ and Kerridge pany websites. For example, if one searches the Lilly blockbuster (2002) state that promotion and marketing to doctors makes Prozac on the internet and goes to the manufacturer’s website up a quarter to a third of their annual budgets “… totaling more one can take self-diagnostic tests which allow the possibility for than US$11 billion each year in the United States alone).There the internet user to self-diagnose depression, even if the site in- are no comprehensive ﬁgures available, but it is estimated that, of this, about US$3 billion is spent on advertising and US$5billion on sales representatives, while expenditure per physician is be- lieved to be over US$8000.” As mentioned earlier in this article Using patient support groups
the Canadian Medical Association Journal in 2002 estimated the US promotional spend to be even higher at approximately Jeﬀries (2000) writing about the Association of the British $19 billion dollars. This activity includes advertising, gift giv- Pharmaceutical industry’s strategy for the future of its mem- ing and support for medically related activities such as travel to bers “The ABPI battle plan is to employ ground troops in the meetings and support for conferences.
form of patient support groups, sympathetic medical opinion Why do ﬁrms spend so much on promotion to doctors? Es- and healthcare professionals – known as stakeholders” which sentially because they rightly see that doctors are the gatekeep- will lead the debate on the informed patient issue”. This tactic is ers to the success of individual brands. To quote Barnes (2003) well illustrated by the following quote from Boseley (1999) “A “Prescribing ‘events’ such as a physician swapping one brand for pharmaceutical company will tomorrow break new ground by another …. Can make or break a brand’s success.” encouraging the public to demand that the NHS pay to make Doctor-targeted promotion takes a variety of forms: available one of its drugs. The campaign, Action for Access, is Gifts, such as free samples, small stationery (Riccardi funded by Biogen and organized by a PR company on its behalf. 2002), travel to conferences and educational events, and, some It will urge multiple sclerosis suﬀerers to demand their health argue, cash (Medical Marketing & Media 2003, Prawirosujanto authorities agree to prescribe beta-interferon on the NHS, a 2001, Strout, 2001) very expensive drug, which can help some suﬀerers, but not all”. Sponsorship of conferences and educational events EJBO Electronic Journal of Business Ethics and Organization Studies (Moynihan 2003, Hayes et al 1990, Komesarroﬀ and Kerridge advantages over existing listed medicines The use of key opinion leaders – i.e. senior clinicians and medical educators as speakers at learned conferences Lerer Prescribing of fewer generics and more expensive new medications at no demonstrated advantage.
Funding of medical journals through advertising. Komesaroﬀ and Kerridge (2002) also point to the many Pharmaceutical companies use medical journals to advertise studies that indicate the advertising rather than clinical evidence their products, and frequently advertising revenue is the only alone aﬀects clinical decision-making. They cite Peay and Peay source of funding of these journals, which are often sent free to (1988) who found that physicians exposed to advertising are doctors. Smith (2003), the editor of the British Medical Journal, more likely to accept commercial evidence, rather than well-es- writes thus of advertising by Big Pharma “To attract advertising tablished scientiﬁc views.
these publications have to be read by the doctors whom the ad- As Lexchin and Mintzes (2002) argue, if advertising re- vertisers want to reach. So the free publications work hard at sults in these negative outcomes with physicians who are more making themselves attractive, relevant, interesting, and easy to knowledgeable about drugs and can more easily access objective read – in contrast to journals, which are often delivering com- information, “how realistic is it to believe that consumers will be plex, diﬃcult to read material of limited relevance.” Davidoﬀ et positively aﬀected?” al 2001 write of a decision among the editors of some of the world’s largest medical journals to adopt a common policy of disclosure of information about the source and validity of arti- Why should this we be concerned with this?
cles submitted for publication, and possible conﬂicts of interest. Hence, for example, contributors to the British Medical Journal There are a number of key reasons for concern about the im- must disclose any potential conﬂicts of interest that might arise. pact of pharmaceutical companies’ marketing strategies. These This policy does not however apply in the non-medical press include: and women’s magazines, and many of the world’s broadsheets The fact that drug promotion is often misleading carry thinly-veiled info-mercials for medical conditions, such as Revill’s coverage of female testosterone deﬁciency in the United The increasing costs of drugs within national health Kingdom national newspaper The Observer in Jan 2003.
“ We doctors are shamelessly manipulated by drug compa- New drugs are the ones most heavily promoted and nies in all sorts of ways. .the methods cover the whole spectrum these are the ones with the least well-understood safety pro- from subliminal to brazen, from little pens that don’t work to ﬁles.
Drug promotion often misleading
Doctors’ responses to Big Pharma promotion
Much drug advertising is misleading. A U.S. congressional Doctors are obviously not undiscerning recipients of adver- inquiry reported that from August 1997 to August 2002 the tising and other forms of promotion. Smith (2003) says “Your FDA issued 88 letters accusing drug companies of advertising opinion may not be bought, but it seems rude to say critical violations. In many cases companies overstated the eﬀectiveness things about people who have hosted you so well.” He goes of the drug or minimised its risks (Gottlieb 2002). Aitken and on to say that the easy dichotomy of pharmaceutical giants as Holt (2000) found that the FDA ﬁled violation notices for one villains and doctors as innocent victims is over-simplifying the in four products supported by DTCA. As discussed earlier the situation. Clearly doctors need to use drugs in order to deliver instance of non-compliance with medicines board’s require- their services, and it is also reasonable that ﬁrms should be al- ments for accuracy is even higher in New Zealand. PHAR- lowed to promote their products. “But surely doctors should be MAC, the New Zealand government’s drug purchasing agency, looking also to independent sources of information, and how has raised considerable concerns about the impact of DTCA did we reach a point where so many doctors won’t attend an saying that consumers interpret the existence of DTCA as gov- educational meeting unless it’s accompanied by free food and a ernment approval of advertised brands, which leads them to discount potentially important risk information. Separate studies by McInney, Scheidermeyer, Lurie et al (1990), Banks and Mainour (1992) and Chren, Landefeld and Murray (1989) all found that there was a strong correlation Misleading advertising can lead to unrealistic
between doctors’ tendencies to recommend drugs and their re- expectations
ceipt of gifts/sponsorship/ non-related payment etc. Studies by Wazana (2000), Chren et al (1989) and Thomson, Craig and There are many instances of inappropriate drug advertising. Barnham (1994) all show that gifts impact on doctors’ prescrib- Healthy Skepticism New Zealand (HSNZ), a publication of ing practices. Wazana (2000) examined 29 empirical studies of the Medical Lobby for Appropriate Marketing, focused on some the impact of interactions between the medical profession and of the issues relating to promotion of Viagra in June 2000. They Big Pharma. Synthesising these ﬁndings certain negative out- found that the product claims made were in many cases inap- comes were found to be associated with interactions with the propriate since they did not oﬀer enough clarity. The Pﬁzer ad in New Zealand was as follows “About 52% of men aged 40 to Inability to identify inaccurate claims about medica- 70 are aﬀected by erectile dysfunction ….In clinical trials 78% of men reported improvements in their erections. So Viagra will Rapid adoption and prescription of new drugs work in about 4 out of 5 men.” HSNZ took issue with the ad on Formulary requests for medications without important the following grounds: EJBO Electronic Journal of Business Ethics and Organization Studies The 52% ﬁgure was inaccurate and misleading and had by Medawar (2001).
no basis in fact. It was rather the extrapolation of a very limited These views are directly at odds with the reality of pharma- but favourable related clinical trial.
ceutical industry practices such as that of increasing brand pen- This claim could aﬀect men with conﬁdence rather etration through identifying new ailments that may be treated than medical problems – they argue that “exaggerating the se- by existing drugs (thus extending the brand’s target markets and verity and/or frequency of conditions to expand markets has potentially its sales). This is well illustrated by U.S. advertise- ments promoting the Pﬁzer anti-depressant Zoloft as a poten- That “will work” was misleading since it might give the tial solution to PMDD – pre-menstrual dysphoric disorder, impression that Viagra would “work well enough to enable suc- which has symptoms not that dissimilar to pre-menstrual syn- cessful sex” which was not always true. They point to clinical drome (PMS). Similarly the BBC reported a story in Sep 2000 studies which suggest that the success rate of Viagra was in fact of the propensity of U.K. doctors to prescribe Proxac for PMS They also point out that eﬃcacy in the real world may not equate to the eﬃcacy reported in clinical trials because of halo eﬀects created by enthusiastic specialists.
They suggest that the ad is “a fallacy of over-simpliﬁ- cation” which doesn’t convey that improvement in dysfunction Ess, Schneeweiss and Szucs (2003) show that expenditures may not result in successful sex, and is a function of the degree on drugs have grown faster than the gross national product in all European countries, as in the United States. They identify the While patients might be very disappointed because of un- various methods by which member states attempt to control. realistic expectations based on advertisements, these are not as Increased controls on costs – by price ﬁxing, or drug budgetting serious as what HSNZ see as the irresponsible downplaying of . This parallels the United States where Health Maintenance risks. In a much smaller font on the ad the following three sen- Organisations and company health schemes already limit their tences are printed in bold: “You must not take Viagra if you are formularies and will not pay for certain drugs (this is not to sug- using any nitrate medication including amyl nitrate (poppers). gest formulary limitation is in itself wholly negative, it depends It may lead to a severe drop in your blood pressure, that may be on the selection criteria used to make decisions on whether to diﬃcult to treat. As sexual activity may be a strain on your heart include or exlude drugs). your doctor will need to check whether you are ﬁt enough to use For example both the Californian Health Maintenance Or- Viagra.” HSNZ take issue with this warning because they feel it ganisation Kaiser Permanente, and the NHS in Britain refuse is inadequate, because the use of technical terms such as nitrate to reimburse patients for Viagra. Moynihan (2003) also points medication, rather than brand names may mean that those po- out that costs have spiraled for drugs, vastly exceeding national tentially at risk do not recognize the risks; “readers may not real- rates of inﬂation. Echoing Medawar’s (2002) point, it would ize that the ‘severe drop in blood pressure’ may be a euphemism seem clear that Big Pharma has decided to harvest its invest- for death”; and it does not refer to existing evidence of the con- ments in development. At least some of the considerable na- siderable risks that may exist for some potential users and the tional expenditures on drugs each year is due to inappropriate number of deaths that have been associated with the inappro- prescribing for conditions that do not require drugs – the dis- priate use of Viagra. In 1998 Brooks showed evidence that 69 ease mongering spoken of earlier. Another considerable element deaths associated with the inappropriate use of Viagra with le- of the expenditure is related to prescribing newer more expen- gitimately prescribed but contra-indicated drugs. HSNZ make sive medications where older less expensive medications would reference to a number of studies that show that there are many be just as good. This would seem to be borne out by Stern and contra-indications for Viagra, and they feel that these contra-in- Ehrenberg’s (2003) ﬁnding that 80% of pharmaceutical market- dications should be more openly and clearly ﬂagged. For similar ing managers believed that the easiest way to increase the sales issues see also Blondeel (1997), www.bbc.co.uk/panorama - Se- of their drugs was to get existing users to prescribe them more. They argue however that pharmaceutical ﬁrms would be bet- ter advised to acquire more customers, i.e. generate more occa- sions for prescribing. Either way the implications for costs are Disease Mongering
enormous. It is important to note though that that increased prescribing is only cost ineﬃcient if medications are prescribed Thomas (1980) wrote of his concerns about the potentially inappropriately. If they are being used appropriately they may negative impacts of increased drug and disease promotion. He save money from other more expensive elements of the health felt that the constant emphasis on health risk and the promul- care system, in particular hospital costs.
gation of the view that people are “fundamentally fragile, always on the verge of mortal disease” was simply untrue. He sug- gested that “The new danger to our well-being, if we continue What needs to happen?
to listen to all the talk, is in becoming a nation of healthy hy- pochondriacs, living gingerly, worrying ourselves half to death.” Current regulation of marketing practice by pharmaceutical This view is also held by Mintzes (2002) who gives examples manufacturing consortia such as the Association of the British of the direct relationship between exposure to advertising and Pharmaceutical Industry (ABPI), US PhRMA organisation enrolment in drug regimens that are not always necessary or ap- and the Irish Pharmaceutical Healthcare Association (IPHA) propriate. Shapiro and Shultz (2001) argue that the increased is more than forgiving. For example in the case of sponsorship public exposure to media advertising and discussion of antide- of sponsorship of overseas travel the IPHA has the following pressants such as Paxil (Seroxat) and Prozac have directly led to to say: the inappropriate prescribing of these drugs to patients whose “Companies may be requested to sponsor the travel expens- symptoms do not merit such extreme therapies, a view shared es of a member of the health professions attending and overseas EJBO Electronic Journal of Business Ethics and Organization Studies international scientiﬁc conference. The expenses incurred by the delegate in attending such a conference can reasonably be paid A way forward
to the delegate by the company and this is acceptable. Hospital- ity extended by a company to a delegate attending an overseas Clearly there are many aspects to this issue, not least the ar- meeting must be reasonable in level and secondary to the major gument frequently put forward by Big Pharma that they fund purpose of the occasion at which it is provided. Hospitality must the majority of research into often life-saving therapies and are not be extended beyond health professionals.” (IPHA 1999) therefore net contributors to society. There are also obviously Similarly the ABPI has this to say about members’ involve- the wider philosophical debates about the degree to which soci- ment in continuing medical education: “the pharmaceutical in- eties should be regulated, and issues around deﬁning reasonable dustry is also deeply involved in doctors’ continuing education, proﬁt and appropriate business behaviour which beleagur many and helps in training prescribers in the uses and techniques of sectors, not just Big Pharma. However not withstanding these new medicines. G.P.s and other health professionals would ﬁnd elements, I argue that two things should happen – it diﬃcult to keep up to date with scientiﬁc and medical ad- Independent monitoring bodies should be established vances without these initiatives.” (ABPI 2003)They go further to police marketing codes of practice with real penalties and, in a position paper to say that the ABPI directly complies with increased attention should be paid to the education of UK statutory regulations on the marketing and promotion of the consumers of pharmaceutical advertising, in particular those The US equivalent organization PhRMA adopted a volun- tary code of practice for its member organizations in July 2002 that seems to propose the toning down of the extremes of gift- Independent monitoring of marketing codes of
giving and inducements to doctors. However in reading the practice with real penalties
question and answer section ay the end of the code of practice it is clear this is not the case. Gift giving and generous hospitality, The pharmaceutical industry should not be self-regulating and in some cases, fees for endorsement of products, are still in this vital area since misleading/inaccurate pharmaceutical very much allowable. It is important to note that in the United promotion can have very serious impacts. Rather governments States while PhRMA has its own voluntary code, the FDA still and national medicines agencies should take pro-active stances actively monitors promotion, though it lacks the resources to in monitoring drug advertising and promotion practices, with monitor more than a fraction of all promotion, and there are real penalties, in particular substantial ﬁnes. The current reac- tive and non-dedicated status of monitoring agencies is inad- This begs the question is it appropriate to allow an industry equate. This is in part due to the inadequate resourcing of such such as Big Pharma to self-regulate in the area of marketing? organisations. This might be countered by an arrangement such Should this not be the role of government, or wider industry as that underpinning the Superfund of the US Environmental organs such as the International Chamber of Commerce (ICC). Protection Agency, where industry members pay a levy to fund Taking the ICC role ﬁrst it is clear that while individual phar- the monitoring of environmental impact and the policing of maceutical companies may well be members of the ICC, they polluting behaviour. Similarly, in 2002, the U.S. Government’s do not often adhere to the again voluntary code of marketing Sarbanes-Oxley Act established the Public Company Account- practice which states the following about sales promotion for ing Oversight Board to be funded by industry contribution, example “all sales promotions should be legal, decent and honest which replaced industry self-regulation, which was seen to have … all sales promotions should be so designed and conducted as failed following the major ﬁnancial scandals associated with En- to avoid causing justiﬁable disappointment or giving any other ron and WorldCom. grounds for reasonable complaint” (ICC2002). Would phar- In addition to adequately funded monitoring bodies to over- maceutical promotion meet these standards? The evidence of see marketing practice, the system of penalties for infringement research into the promotion of products such as Viagra , Serox- need to be overhauled. While many countries have codes of at/Paxil and Baycol would suggest not. The fundamental issue practice, and agreed understandings as to appropriate practice, in the case of industry organization codes (including ICC) is such as the U.S. FDA code of practice, often the penalty sys- the real absence of sanction. PhRMA’s code of practice is vol- tems are inadequate to the point of being ineﬀectual. untary, as are IPHA’s and ABPI’s, and “each member company For example under the United Kingdom’s ABPI code of is strongly encouraged to adopt procedures to ensure adherence marketing practice complaints about infringement can be made to this code”(PhRMA 2002). It could be argued that such vol- by anyone including members of the public. The company has untary self-regulatory codes are not designed to ensure accu- six weeks to respond in writing, with a defense of the issue at racy and objectivity, but are instead set up to ‘level the playing hand. This complaint is then considered by a panel of three peo- ﬁeld’ among member companies. An examination of the origin ple with legal backgrounds, on behalf of the ABPI. If the com- of complaints to such bodies indicates that most tend to come pany is found to be in breach of the code of practice they will from other drug companies (Lexchin 2003).
incur a ﬁne in the order of £1000 (approx US$1670) and be required to give an undertaking to withdraw all oﬀending ma- terials within approximately two weeks. If the breach is judged Role of Government
to be serious, and to “bring the industry into disrepute” then the ﬁne will be more severe, but still relatively small. While there are government agencies charged with monitor- If one considers the proﬁts to be made within the pharma- ing the marketing of medicines, typically this is one of many ceutical sector, and the potential human risks associated with briefs for these agencies and is often only in a reactive fashion. misleading or inaccurate promotion, it would seem clear that In other words such monitoring as does occur, occurs only in the penalties for breaches of marketing codes of practice should response to complaints, and even then is often very slow and be commensurate. It could well be argued that the ﬁnes that apply in many countries are ﬁnancially insigniﬁcant to Big Phar- EJBO Electronic Journal of Business Ethics and Organization Studies ma, and therefore considered eﬀectively a cost of doing business schools, for example, across Ireland and Britain shows that at present there is no education in the area of business and in par- ticular marketing (English Maher 2003). This should surely be addressed, so that at least doctors, and others with prescrib- Increased education of consumers and those with
ing powers, would understand the techniques and practices to prescribing powers
which they will be subjected as practitioners. Initiatives are being taken to increase awareness of the na- In addition to increasing the monitoring and policing of ture and impacts of pharmaceutical promotion in the United Big Pharma promotion, it would seem prudent to increase the States. Signiﬁcantly the American Medical Student Associa- awareness and sophistication of the key promotion targets, tion has recently begun a campaign to regulate the relationship through increased education about marketing. General con- between Big Pharma and medical students (Moynihan 2003). sumer education is diﬃcult to achieve, as is daily evidenced by The PharmFree pledge that the American Medical Student As- the limited success of public health promotion campaigns such sociation propose students sign includes the following “I will as those around the health risks of smoking. That is not to sug- make medical decisions … free from the inﬂuence of advertising gest that it should not be attempted, but it would be unwise to or promotion. I will not accept money, gifts or hospitality that expect it to have immediate and universal impacts. While gener- will create a conﬂict of interest in my education, practice, teach- al consumer awareness may be diﬃcult to achieve, considerable ing or research.” The tenor of the PharmFree pledge should be opportunity exists for increasing the knowledge base of those the guiding point for setting standards of practice for pharma- with prescribing powers. A review of the curricula of medical ceutical marketing. Bibliography
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PS8151 - VENDITA FARMACI ON LINE Provvedimento n. 23632 L’AUTORITÀ GARANTE DELLA CONCORRENZA E DEL MERCATO SENTITO il Relatore Professor Piero Barucci; VISTA la Parte II, Titolo III, del Decreto Legislativo 6 settembre 2005, n. 206 e successive modificazioni (di seguito, Codice del Consumo); VISTO il “ Regolamento sulle procedure istruttorie in materia di pratiche commerciali scorre