[e-drug] Doctors prescribing heavily influenced by DTCA (2)

E-DRUG: Doctors prescribing heavily influenced by DTCA (2)
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Thanks for sending announcement of this study out to the list. While it may add fuel to the fire to ban DTCA in the US, I believe that patient requests should have an effect on physician (and all health care professional) behaviors regarding their care. Placing this study in the context of the patient-provider relationship, it should be remembered that most visits with a prescriber end with the generation of a prescription of some kind. Moreover,
we have known for many years that patients demand and receive antibiotic prescriptions when they do not need them (i.e. when there is no physiopathological evidence for need). Other situations have been reported as well.

My opinion is that DTCA is an ethically marginal, short-run strategy for announcing product or service availability for the purpose of increasing sales. It is ethically marginal not because it increases sales (which it does), but because the advertised products are not available for direct purchase. An ethically consistent policy on advertising would be: "Products advertised directly to the public should be available for direct procurement by the public."

My two cents worth.

Richard H. Parrish II, PhD, RPh
Assistant Professor, Pharmacy Practice
The Bernard J. Dunn School of Pharmacy
Shenandoah University
1775 North Sector Court
Winchester, VA 22601 USA
tel: +1 540 678-4392
email: rparrish@su.edu

E-DRUG: Doctors prescribing heavily influenced by DTCA (3)
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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]

E-DRUG: Doctors prescribing heavily influenced by DTCA (4)
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dear E-druggers,

Yes, patients certainly do ask for and get antibiotics for viral upper
respiratory tract infections. But there is evidence that in many cases the
doctor expects that the patient wants an antibiotic and so prescribes it
when in fact the patient doesn't want an antibiotic. One study on
antibiotics and viral URTIs showed that patients who got a good explanation
about what the problem was and NO antibiotic were more satisfied than those
who just got an antibiotic. Expectations are a complex problem that need to
be dealt with at both the patient and doctor end.

Joel Lexchin
--
Joel Lexchin MD
121 Walmer Rd.
Toronto ON
Canada M5R 2X8
Tel: 416-964-7186
Fax: 416-923-9515
E mail: joel.lexchin@utoronto.ca

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

E-DRUG: Doctors prescribing heavily influenced by DTCA (5)
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When patients go to see Doctors, they have their own thinking and
expectations. At some point, during a patient-centred consultation, as
practiced in Family Medicine, patients are asked what their
CONCERNS/EXPECTATIONS are. Patients' answers will guide the Doctor's
explanation after Clinical reasoning. As for the example of a Viral URTI,
the patient may see a Doctor either expecting an antibiotic or just a cough
mixture. The patient may think they have a serious chest infection and
therefore, expects a Chest X-ray. Without understanding the
CONCERNS/EXPECTATIONS of the patient, the explanation to the patient may not
be done and the patient will go away unsatisfied.

Dr. Joseph Mulenga
Zambia
docmulengajo@zamtel.zm

E-DRUG: Doctors prescribing heavily influenced by DTCA (7)
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Jonathon,

When I have discussed DTCA with politicians one of the arguments they want
to test is: "We might as well let the companies do DTCA on TV etc because
people will be exposed to DTCA on the internet and we can't stop that."

Here is my response.

DTCA on the WWW is a worse problem when it is linked to drug supply that
bypasses the partial safe guard of doctor's prescriptions. Drug company
websites sometimes refer people to lists of doctors who they know are likely
to prescribe the drug being promoted.

However WWW DTCA is otherwise less of a problem because it is less effective
for two reasons.

1. DTCA on TV and radio and in newspapers and magazines exposes a large
percentage of the population. WWW DTCA is rarely seen except by a minority
who seek it. The people who seek information on the WWW sometimes seek
information from multiple sources so they may get some other sides to the
story unlike with TV ads. (Junk email is in an in between category but is
not used by drug companies as far as I know.)

2. The WWW is rarely able to hijack people into being exposed to a stream of
images that build to a strong emotional appeal in the way that is possible
with TV and to a less extent the other older media.

It may be possible to regulate DTCA on the internet. For example Drugs could
be licensed on the condition that there be no internet DTCA including access
blocks preventing people using internet service providers based in your
country from accessing internet DTCA in the USA.

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