[e-drug] Doctors prescribing heavily influenced by DTCA (6)

["Jonathan Harper" <jrharper@axelero.hu>]

E-DRUG: Doctors prescribing heavily influenced by DTCA (6)
----------------------------------------------------------

Dear Edrug, 

DTCA occurs all the time via internet. There are practically few regulatory controls of internet advertising and sale in all countries. 

Effective regulatory control of advertising (and sale) channels for prescription medicines should be an absolute requirement and prerequisite; but the absence of regulatory control of internet DTCA, is in my opinioon the greatest danger (not just for medicines, but several other sectors also). 

Dr Jonathan R Harper; MB ChB, BSc (hons), MBA
Author of report 'Harmonised provisions for legislative and administrative procedures applicable to counterfeit medicines in the Council of Europe Member States' (due to be published Mid 2005)

1066 Budapest 
Dessewffy u. 38  1/6
Hungary
Tel/Fax: +36 1 269 2723
Tel: +36 26 340 038
Mob: +36 70 240 3780
jrharper@axelero.hu




----- Original Message ----- 
From: "Dr Peter R Mansfield" <peter.mansfield@adelaide.edu.au>
To: "'Essential Drugs in English'" <e-drug@healthnet.org>
Sent: Saturday, April 30, 2005 12:32 AM
Subject: [e-drug] Doctors prescribing heavily influenced by DTCA (3)


> E-DRUG: Doctors prescribing heavily influenced by DTCA (3)
> ----------------------------------------------------------
> 
> Richard,
> 
> DTCA is unethical because it does more harm than good.
> 
> Please find below our BMJ editorial.
> 
> regards,
> 
> Peter
> 
> Dr Peter R Mansfield
> GP
> Research Fellow, Department of General Practice, University of Adelaide
> peter.mansfield@adelaide.edu.au
> NHMRC Public Health Postgraduate Scholarship 250465
> On study leave from Healthy Skepticism Inc during 2005 to write PhD thesis
> www.healthyskepticism.org Countering misleading drug promotion.
> 34 Methodist St, Willunga SA 5172 Australia
> 
> Mansfield PR, Mintzes B, Richards D, Toop L.
> Direct to consumer advertising.
> BMJ 2005 Jan 1;330(7481):5-6
> http://bmj.bmjjournals.com/cgi/content/full/330/7481/5
> 
> Editorial
> 
> Direct to consumer advertising 
> Is at the crossroads of competing pressures from industry and health needs 
> 
> 
> The challenge for governments evaluating direct advertising of prescription
> only drugs to the consumer is how to achieve maximum benefits for health and
> wealth while minimising harm. New Zealand's health minister, Annette King,
> has taken the advice of New Zealand's health professional and consumer
> groups and has decided that the potential benefits of "direct to consumer
> advertising" do not justify the harms and so plans to ban it from 2005.w1
> That will leave the United States as the only industrialised country
> allowing full direct to consumer advertising of prescription medicines. An
> Australian review of drug legislation in 2001 concluded that prohibiting
> such advertising produces a net benefit for the community as a whole.1 In
> 2002, the European Parliament rejected a proposal to allow advertising for
> drugs used to treat asthma, AIDS, and diabetes directly to the consumer. A
> 2004 Canadian parliamentary inquiry recommended against direct to consumer
> advertising because "Drug advertisements could endanger rather than empower
> consumers by minimizing risk information and exaggerating benefits" and
> "could contribute to increased or inappropriate drug consumption."2 
> 
> Direct to consumer advertising increases the use of drugs and medical
> services and increases wealth for pharmaceutical, advertising, and media
> companies.3 It increases prescribers' workloads and increases expenditure by
> patients, taxpayers, insurers, and large employers. For example, General
> Motors USA has identified direct to consumer advertising as a major cost
> driver increasing payments for health care for its workers and thus
> increasing the cost of building cars.w2 Such increased costs might be worth
> while if direct to consumer advertising delivered value for money by
> improving health. 
> 
> Unfortunately, the situations where direct to consumer advertising could be
> most beneficial (by stimulating appropriate use of drugs for high priority
> health needs) do not often match the situations where it is most profitable.
> As one advertising industry executive explains: "Direct to consumer is
> suited for things where patients have a greater interest than doctors.
> Non-life threatening conditions, such as erectile dysfunction..."w3 Such
> promotion may be beneficial as well as harmful. For example, while the
> promotion of sildenafil and its competitors may motivate men, who might not
> do so otherwise, to see a general practitioner, and possibly address other
> health needs, it has been shown to increase distress if it raises
> expectations that are unfulfilledw4 and is a haphazard approach to health
> promotion for populations. Direct to consumer advertising is most profitable
> for expensive new drugs.4 Because the long term health effects of new drugs
> are unknown it is often difficult to know whether the increased costs are
> justified. There are also opportunity costs when advertising stimulates
> rapid adoption of new drugs without established advantages over cheaper
> alternatives, especially in public health systems with finite resources. 
> 
> Proponents of direct to consumer advertising claim it increases public
> knowledge. This might be so if it delivered reliable balanced information.
> Such advertising does increase awareness of drugs, but its purpose, as with
> all advertising, is to persuade rather than to inform. Direct to consumer
> advertising leaves many people with exaggerated perceptions of the benefits
> of drugs.5 Providing balanced information about harms, alternatives, and
> costs is likely to reduce efficacy and profitability of advertisement.
> Demand stimulated by such advertising creates dilemmas for doctors who
> aspire to be both patient centred and evidence based. For this reason, many
> health professionals and their representative organisations strongly oppose
> advertising directly to consumers.6 
> 
> In countries where full direct to consumer advertising is illegal, drug
> companies are increasingly pushing the limits of regulatory systems, with
> disease oriented advertising, public relations campaigns, reminders, and
> unbranded direct to consumer advertising.w3 Requirements to provide any
> balancing information do not exist because such advertising has arisen by
> default via regulatory loopholes. For example, in Canada a price advertising
> clause from 1978 has been used to allow reminder advertisements, including
> advertising in July 2004 for a contraceptive patch by name without warnings
> about adverse effects.7 w5 Earlier this year Glaxo-SmithKline paid a
> celebrity, Impotence Australia, and a couple who had used vardenafil to
> promote the drug via the Australian news media.8 The brand name was
> mentioned without appropriate balancing information. In 2003 staff of the
> World Health Organization expressed concern that disease oriented
> advertisements in France that were funded by Pfizer, manufacturer of
> atorvastatin, "contained misleading statements and omissions likely to lead
> to unjustified medicine use."9 They recommended that governments "urgently
> increase vigilance with respect to drug promotion." Few if any governments
> seem to be heeding this advice. In 2004, Canada's health minister, Pierre
> Pettigrew, indicated that a nearly identical advertisement was not subject
> to regulation because it fell outside the legal definition of product
> specific advertising.w6 
> 
> Two studies of unbranded advertising directly to consumers have been
> published. Prescribing of sumatriptan was higher in cities in the United
> States that had been exposed to a campaign in 1993 recommending that people
> ask their doctor about a "surprisingly effective" new treatment for
> migraine.10 Novartis's unbranded television advertisements in the
> Netherlands increased consultations for onychomycosis and prescribing of
> terbinafine while decreasing use of its competitor.11 The country's health
> inspectorate tried to stop this campaign, but a court allowed it because
> neither the product nor the company was named. 
> 
> Governments are under pressure to create business friendly environments for
> politically powerful industries to invest.12 At the same time they must
> manage health services to give priority to health needs. Policy on direct to
> consumer advertising is at the crossroads of those competing pressures. In
> the face of unsuccessful attempts at legislative change to allow advertising
> directly to the consumer, lax enforcement of existing laws may ease pressure
> on governments from those politically powerful industries, but it is
> contrary to democratic principles and may harm both public health and
> national wealth. 
> 
> The public is ill served when governments allow promotion of prescription
> drugs that stretches the limits of the law-and beyond. No country has been
> successful at regulating any type of direct to consumer advertising to
> ensure the public obtains reliable balanced information on drug benefits and
> risks.3 6 Repeated breaches by companies speak for themselves.3 The
> potential awareness raising benefits of direct to consumer advertising could
> be better targeted and sustained at lower cost with less harm through
> publicly funded and accountable drug information services and health
> campaigns. 
> 
> Peter R Mansfield, director 
> Healthy Skepticism Inc., 34 Methodist St., Willunga, SA 5172, Australia
> (peter@healthyskepticism.org) 
> 
> Barbara Mintzes, postdoctoral fellow 
> University of British Columbia, #429-2194 Health Sciences Mall, Vancouver,
> BC, Canada V6T 1Z3 
> 
> Dee Richards, senior lecturer general practice, Les Toop, professor of
> general practice 
> Department of Public Health and General Practice, Christchurch School of
> Medicine, University of Otago, PO Box 4345, Christchurch, New Zealand 
> 
> Additional references w1-w6 are on bmj.com 
> Competing interests: None declared. 
> 
> References
> 
> Galbally R. Review of drugs, poisons and controlled substances legislation
> (the Galbally review): final report. Therapeutic Goods Administration
> (Australia), 16 October 2001. www.tga.health.gov.au/docs/html/rdpdfr.htm
> (accessed 11 Aug 2004). 
> Brown B. Standing committee on health. Opening the medicine cabinet: first
> report on health aspects of prescription drugs. Ottawa, Ontario: House of
> Commons, 2004. 
> United States General Accounting Office. FDA oversight of direct-to-consumer
> advertising has limitations. Report to congressional requesters GAO-03-177.
> October 2002. www.gao.gov/new.items/d03177.pdf (accessed 11 Aug 2004). 
> National Institute for Health Care Management Research and Educational
> Foundation. Prescription drugs and mass media advertising, 2000. Washington,
> DC: NIHCM, 2001. www.nihcm.org/DTCbrief2001.pdf (accessed 14 Aug 2004). 
> Woloshin S, Schwartz LM, Welch HG. The value of benefit data in
> direct-to-consumer drug ads. Health Affairs web exclusive 28 April 2004.
> http://content.healthaffairs.org/cgi/content/full/hlthaff.w4.234v1/DC1
> (accessed 14 Aug 2004). 
> Toop L, Richards D, Dowell T, Tilyard M, Fraser T, Arroll B. Direct to
> consumer advertising of prescription drugs in New Zealand: for health or for
> profit? Report to the Minister of Health supporting the case for a ban on
> direct to consumer advertising. New Zealand departments of general practice.
> Christchurch, Dunedin, Wellington and Auckland Schools of Medicine. February
> 2003. www.chmeds.ac.nz/report.pdf (accessed 11 Aug 2004). 
> Gardner D, Mintzes B, Ostry A. Direct-to-consumer prescription drug
> advertising: permission by default? CMAJ 2003;169: 425-7.[Free Full Text] 
> Sweets' potent drug. Media Watch ABC TV transcript, 22 March 2004.
> www.abc.net.au/mediawatch/transcripts/s1071337.htm (accessed 11 Aug 2004). 
> Quick JD, Hogerzheil HV, Rago L, Reggi V, de Joncheere K. Ensuring ethical
> drug promotion-whose responsibility? Lancet 2003;362: 427. 
> Basara LR. The impact of a direct-to-consumer prescription medication
> advertising campaign on new prescription volume. Drug Inf J 1996;30: 715-29.
> 
> 't Jong GW, Stricker BH, Sturkenboom MC. Marketing in the lay media and
> prescriptions of terbinafine in primary care: Dutch cohort study. BMJ
> 2004;328: 931.[Free Full Text] 
> Abraham J. The pharmaceutical industry as political player. Lancet 2002;360:
> 1498-501.[CrossRef][ISI][Medline] 
> 
> 
> This article has been cited by other articles: 
>  
> M. F. Hollon
> Direct-to-Consumer Advertising: A Haphazard Approach to Health Promotion
> JAMA, April 27, 2005; 293(16): 2030 - 2033. 
>  
> M. Hochhauser
> Direct to consumer marketing: Advertising directly to consumers may affect
> patients' safety
> BMJ, April 16, 2005; 330(7496): 906 - 906. 
>  
> M. Duerden and T. Walley
> Direct to consumer marketing: Switch to over the counter can become indirect
> advertising directly to consumers
> BMJ, April 16, 2005; 330(7496): 906 - 906. 
> [Full Text] 
> 
> 
> 
> 
> 
> 
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