Rapid Responses to:

FEATURE:
Les Toop and Dee Mangin
Industry funded patient information and the slippery slope to New Zealand
BMJ 2007; 335: 694-695 [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] Anecdotal instance of positive effects of drug advertising
Charles L. Rogerson   (13 October 2007)
[Read Rapid Response] Fewer pharmacists. More farm-assists.
Hugh Mann   (14 October 2007)
[Read Rapid Response] Pitfalls of other sources of patient informations; another form of stealth advertisement?
Mohamed Sakel   (15 October 2007)
[Read Rapid Response] article is misleading ...
Dr Pippa MacKay   (1 November 2007)
[Read Rapid Response] Authors response
Les Toop, Dee Mangin   (5 November 2007)
[Read Rapid Response] Consumer Response to DTCA
Janet A Hoek   (10 November 2007)

Anecdotal instance of positive effects of drug advertising 13 October 2007
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Charles L. Rogerson,
Clinical Data Architect
slough sl1 1th

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Re: Anecdotal instance of positive effects of drug advertising

I think this article doesn't give enough weight to the intelligence of patients and their interest in getting information about their medications.

Anecdotally, an older acquaintance of mine in the States who was a very active hiker developed fairly rapid onset of bilateral leg weakness which increased over a year to the point where he could only walk very short distances. He consulted his GP and several specialists and was finally referred for spine surgery, which he declined.

He then saw an ad for a statin he was taking on television, in which the narrator at the end listed the side-effects, which included muscle weakness. He immediately went to his GP, who DC'd the statin.

The leg weakness immediately improved, though unfortunately not completely. Somehow his physicians had missed this rather obvious possibility.

I believe this may demonstrate that in a clinical environment where clinicians do not communicate fully to their patients the mechanisms and side-effects of prescribed medications, televised medication advertisements similar to those published in medical publications can play a positive role in educating patients.

Competing interests: None declared

Fewer pharmacists. More farm-assists. 14 October 2007
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Hugh Mann,
Physician
Eagle Rock, MO 65641 USA

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Re: Fewer pharmacists. More farm-assists.

I am not anti-pharmaceutical. As a physician, I recognize that pharmaceuticals have a place in health-care. However, I object to the cozy relationship between the pharmaceutical industry and physicians, in which the pharmaceutical industry provides physicians with "education" and "gifts." I also object to the dominant role of pharmaceuticals in health-care and patient education.

Since life is metabolism, and since metabolism depends on food and water, health-care should focus on food and water. Of course, this logic threatens the monopoly that the pharmaceutical industry enjoys over health-care. It is appalling that the pharmaceutical industry is making a fortune, while farmers are going bankrupt. Society needs fewer pharmacists and more "farm-assists."

Competing interests: None declared

Pitfalls of other sources of patient informations; another form of stealth advertisement? 15 October 2007
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Mohamed Sakel,
Director NeuroRehabilitation Services East Kent, Consultant Physician
NeuroRehabilitation Unit,East Kent Hospitals Trust CT2 7AN

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Re: Pitfalls of other sources of patient informations; another form of stealth advertisement?

Toop and Magin discussed concerns about industry provided information. I have concerns about Voluntary societies (VS) providing information directly to patients as well.On the whole, VS provide an invaluable role in patient care. But, their infomation sheets may have unintended harmful consequences. These information sheets describe a generalised narrative without taking into account the individual context and the uncertainties in the natural history of the condition. This may generate misleading perception of prognostic apprisal by the patient/ carer ,eg Motor Neuron Disease life expectancy will be described as 3.5 years on average, but an individual patient may well survive longer than 10 years! This may lead to unnecessary anxiety,distress and subsequent difficult consultations in the clinic.

On a more sinister note, is it not possible that these information sheets could well be used as a form of "stealth Ad" by the industry of their "wonderful drug" ? These specialist drugs (likely to be mentioned in the information sheets)are not suitable for all patients. The industry could influence the text of the infiormation sheets by providing financial incentives to the VS or their medical advisors.

I believe, patients should get clinical information from clinicians who should suggest how other sources of information could be accessed. They should also provide guidance about how to interpret those informations.

Competing interests: None declared

article is misleading ... 1 November 2007
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Dr Pippa MacKay,
Chairman
New Zealand

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Re: article is misleading ...

I refer to the feature article published in BMJ 2007 335:694-695 by Professor Les Toop and Dee Mangin titled “Industry funded patient information and the slippery slope to New Zealand”.

The authors are well known campaigners in New Zealand against direct- to-consumer (DTC) advertising of pharmaceutical products. Unfortunately their article is not only misleading for lack of balance and content but it also contains serious errors of fact.

Perhaps the most egregious error is contained in the following statement

“In response to evidence of mounting concern from the public and the professions, the New Zealand government resolved to ban direct to consumer advertising in late 2003. The easiest mechanism seemed to be to include a ban in the omnibus legislation being drafted to set up a joint Australia- New Zealand Trans Tasman agency for the regulation of all therapeutic goods. Advertising of drugs to the public is prohibited by law in Australia. To date the Government has been unable to pass the necessary legislation.”

The authors reference for this statement was an article by Bob Burton of Canberra published in BMJ 2004; 328-68. The authors Toop and Mangin apparently (mis)interpreted Burton’s statement

“After a pre-Christmas cabinet meeting, a brief press release by Ms King [the then NZ Minister of Health] said that she had been authorised to “seek to reach agreement with Australia in March 2004” on a common standard on drug promotion.”

to be a resolution by the New Zealand Government to ban DTC advertising. Nothing could be further from the truth. Apart from the fact that there is no cabinet minute supporting Toop and Mangin’s claim, the Minister of Health, Annette King, in introducing the Therapeutic Products and Medicines Bill specifically stated:

“Direct-to-consumer (DTC) advertising of prescription medicines will continue to be permitted.” (http://www.beehive.govt.nz/ViewDocument.aspx?DocumentID=27993)

Critics contend that DTC advertising harms the doctor-patient relationship, gives rise to inappropriate prescribing and medicalisation and can impact negatively on the pharmaceutical budget. Of these, evidence of inappropriate prescribing and/or harm to the doctor-patient relationship could be sufficiently deleterious to public health objectives to justify limitations or a ban, but this is not the case.

Toop and Mangin never produced any evidence to support their regular assertions that DTC advertising had led to patient harm.

New Zealanders enjoy one of the best doctor-patient relationships in the Commonwealth and the Hoek and Gendall 2003 survey found that the majority of consumers consider that DTCA has no effect on their relationship with their doctor while a good proportion (16%) felt it could improve the relationship.

Likewise there is no evidence that DTC advertising gives rise to inappropriate prescribing in New Zealand. The final treatment decision lies with the doctor who is professionally accountable for the prescribing decision. The fact that the patient may come away with a prescription for the product they enquired about as a result of DTC advertising is not evidence of inappropriate prescribing.

In any event, bans on DTC advertising are being increasingly thwarted by the internet where health care information directed at consumers promote therapeutic products and treatments from seaweed extract to antibiotics and from aromatherapy to plastic surgery.

At least in the case of prescription medicines registration of the product prior to marketing is required with approval based on efficacy, safety and quality.

Furthermore prescription medicines cannot be directly obtained by the consumer and must be prescribed by a registered medical practitioner or other approved prescriber.

Dr Pippa MacKay
Chairman
Researched Medicines Industry Association

Competing interests: The Researched Medicines Industry Association (RMI) is the national body representing New Zealand's research based pharmaceutical industry

Authors response 5 November 2007
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Les Toop,
professor
University of Otago, Christchurch,
Dee Mangin

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Re: Authors response

The introduction to Dr MacKay’s response implies we are lone New Zealand voices opposing DTCA. Support for a ban on DTCA now comes from virtually all health professional groups, including the New Zealand Medical Association, the Royal New Zealand College of General Practitioners, the Royal Australasian College of Physicians, the New Zealand Nurses Organisation, The College of Nursing Aotearoa and the New Zealand College of Midwives (who have limited prescribing rights). These representative bodies are joined by Academic Pharmacy, the Consumers Institute of New Zealand (UKCA equivalent), Grey Power (representing the elderly), Women’s Health Action and many other independent consumer groups, all of whom are calling for more independent consumer health information to replace DTCA of prescription medicines.

Dr Mackay accuses us of “egregious” use of evidence to deliberately mislead readers on the issue of the New Zealand governments desire to ban DTCA. As evidence of this she references a statement on from Minister Annette King from the official government website, announcing the final tabling of the bill around Trans Tasman harmonisation therapeutics regulation (1). What she omitted to include was the sentence immediately following her extracted and selective quote, where Minister King goes on to say:

"The Government's preference was to ban DTCA of prescription medicines; however it is clear that there is not the necessary support within Parliament for that to happen at this point."

We believe this is as clear a statement as is possible of the New Zealand Government’s frustrated intention to ban DTCA, and its ongoing desire to do so at some time in the future.

We, with many others commenting on the parallel situation in the US, have repeatedly set out the ways in which DTCA is of net harm to public health and the ways in which it leads to inappropriate prescribing.

We acknowledge Dr MacKay must represent the views of her employer and their vested interests. The NZMA, whom Dr MacKay previously represented as chair, issued a statement in 2003 which we believe accurately reflects the views of the professions:

“The NZMA is calling on the Government to prohibit Direct to Consumer Advertising (DTCA) of prescription medicines in New Zealand.

‘The NZMA has been reviewing its position on DTCA of prescription medicines and has now decided that the disadvantages outweigh the benefits,’ says NZMA Chairman Dr Tricia Briscoe. ‘We believe it is time for the Government to move into line with most other countries in prohibiting DTCA.’……..

…….‘In our view,’ says Dr Briscoe, ’The pharmaceutical industry, the advertising industry and the Ministry of Health have had plenty of time to make the changes recommended by the 2001 Ministerial Review of DTCA, but have failed to take action. In some instances, pharmaceutical companies have continued to “test the boundaries”.’

‘We no longer have confidence that self-regulation is sufficient to protect the interests of either patients or doctors, nor do we feel that greater government regulation would provide adequate protection. We have therefore come to the conclusion that DTCA of prescription medicines should be prohibited.’

The NZMA position was restated in a submission in 2006 to the latest round of public consultation.

Reference 1 http://www.beehive.govt.nz/ViewDocument.aspx?DocumentID=27993

Les Toop and Dee Mangin

Competing interests: As before

Consumer Response to DTCA 10 November 2007
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Janet A Hoek,
Professor
Massey University, Palmerston North, New Zealand

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Re: Consumer Response to DTCA

In her response to Toop and Mangin’s editorial on direct to consumer advertising of prescription medicines (DTCA), Dr Pippa McKay cites a study that Professor Phil Gendall and I conducted in 2003 and uses this to counter arguments that DTCA has led to patient harm.

It is important to place Dr McKay’s comments in context. All three consumer studies into DTCA we have conducted show that consumers see a sharp imbalance in the risk and benefit information provided in DTCA. In other words, while consumers may have found DTCA helpful, they also see it as flawed. This raises the question of whether other information sources, particularly non-commercial sources, might more effectively meet consumers’ desire to access health information.

The findings from the 2003 and 2004 studies that we conducted were widely disseminated among the advertising industry. Both studies found that risk, side effect and contra-indication information was poorly presented in DTCA and we recommended changes that could address this problem. I also obtained funding from an advertising association to test these changes and made specific recommendations that would improve uptake of risk information in television DTC. Despite this work, none of the recommendations was adopted and details of drug risks, side effects and contra-indications remain difficult to read and interpret, and are best described as information that is hidden in plain view.

Recent work I have conducted has confirmed the pharmaceutical and advertising industries’ failure to respond to and address consumer concerns. In a survey conducted in late 2006, 84% of the 998 respondents surveyed agreed that prescription medicine advertisements over-emphasise benefits and do not explain risks enough. The same survey found 81% agreed that most people lack the technical knowledge to tell whether an advertised medicine is safe and 68% agreed that DTCA leads people to ask their doctor for medicines that may not suit them.

To test an idea that Toop et al first proposed in their 2003 report, namely provision of pharmaceutical information via a disinterested source, I included a specific question to estimate support for this proposal. Sixty percent of respondents agreed that it would be better if the money spent on regulating prescription medicine advertising was used to provide a neutral information service.

Dr McKay is correct in using our data to suggest that consumers wish to access pharmaceutical information. However, it is not correct to suggest that DTCA is the best means of meeting this need or that, given consumers’ general inability to assess the content of DTCA, it may not pose a potential risk to them.

Competing interests: Janet Hoek has received funding for research into DTCA from the Association of New Zealand Advertisers. She last received funding, which supported a post-graduate student, in 2003.