Regarding what you say about Health Canada regulating it, this is my understanding as well - so thanks.

FPME: As late as September I had discussion with the Pharmaceutical Advertising Advisory Board chairman on DTCA and he said that he would provide guidance on any new ad, but Health Canada “regulates” it. Not much regulation happening since there isn’t a huge backlash in Canada against. Yes there is some resistance, but not as organized as here.

…I don’t know the methods of this study but it seems impossible, from what my gut tells me. I think patients have a greater than 1/17 chance of getting a new script/doc visit. So I would think that even if 100% of patients who asked for a med from a commercial got it, it still couldn’t increase new scripts 17X.

Merck had spent more than US $500 million advertising Vioxx to the US public in its five years on the market. In 2000, consumer directed advertising spending for Vioxx surpassed spending for Pepsi-Cola.

2 US cardiologist Eric Topol argued in the New England Journal of Medicine that by not stopping Merck from
advertising Vioxx to the US public while evidence of cardiac risks grew, the Food and Drug Administration (FDA) had failed in its duty to protect public health.3 Just weeks earlier, Peter Wold-Olsen, President of Merck’s Europe, Middle East and Africa Human Health Division, was quoted in Scrip pharmaceutical bulletin arguing that many Europeans were suffering or dying needlessly due to “patient information deprivation syndrome” of epidemic proportions
caused by the European ban on DTCA.4

From the Executive Summary:

This paper examines these claims in light of evidence from research and international experience – and concludes that there is no reliable evidence to support them. For example:
• Analyses of print and broadcast ads in the US have found that information on drug benefits received substantially more space and time than information on risks, and
that key information for informed health care choices, such as how likely a drug is to work or treatment alternatives, is usually missing.
• In a New Zealand survey answered by half the country’s GPs, nearly seven out of 10 reported having felt pressured by patients to prescribe advertised medicines. In 2003,
professors of general practice at four New Zealand medical schools called for a ban on DTCA.
• In a study of 78 primary care physicians’ offices in both the US and Canada, nearly all patients who requested advertised drugs received one or more new prescriptions. These patients were 17 times as likely as other patients to receive one or more new prescriptions during the consultation.
• A systematic review of research on DTCA concluded that “DTCA does influence patient demand and doctor prescribing behaviour. No evidence of health benefit was found
since this had not been examined in any detail [in published research]. . . The onus is on those who might support DTCA to produce evidence of benefit and, in the absence
of this evidence, we must assume that the likely disbenefits (clinical and economic) outweigh the as yet unproven benefits.”

The Parliamentary Standing Committee on Health, in its 2004 report Opening the Medicine Cabinet, has recommended that Health Canada should:
• immediately enforce the current prohibition of all industry-sponsored advertisements on prescription drugs to the public;
• ensure the provision of independent, unbiased and publicly financed information on prescription drugs to Canadians;
• dedicate specific resources to vigorously enforce DTCA regulations, including active surveillance, identification of potential infractions, appropriate corrective action and
annual reports;
• ensure that all complaints about DTCA sent to Advertising Standards Canada and the Pharmaceutical Advertising Advisory Board are forwarded to Health Canada for investigation and action.

These conclusions were supported across the political spectrum. However, there has been
little discussion on implementation since the report’s release.
5

FYI for anyone interested, Canadian drug advertising Act:

Scope

This policy applies to all types of information disseminated in relation to drugs for use in humans.

Background

There are numerous provisions within the Food and Drugs Act and Regulations that apply to drug advertising. In order to determine the applicability of those provisions it is first necessary to determine whether or not a particular message can be considered to be advertising. For the purposes of the Act, advertising is defined as including “any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device”. If a message regarding a drug is not considered to promote sale or disposal, it is not subject to the advertising provisions of the Food and Drugs Act and Regulations.

There is a particular need to distinguish between advertising and non-promotional information in the following situations:

1. Prior to market authorization:

* promotion of a drug prior to market authorization is not permitted (Section 9(1) of the Act, Section C.08 002 of the Regulations) because the terms of such authorization have not been established and the proposed indication(s) for use have not been verified.

2. After market authorization when information on a drug is disseminated to the general public:

* promotion of a prescription drug (Schedule F) to the general public is limited to name, price and quantity (Section C.01.044 of the Regulations).

* a drug (prescription or nonprescription) may not be advertised to the general public for the treatment, preventative or cure for any Schedule A disease (Section 3 of the Act).

I was surprised to hear that Vytorin was in Canada, so I checked the TPD website and it doesn’t show up there. Are you sure it is approved?

I agree with Atlex, the percentage of expense to the A&P spend of DTC would be minor compared to sales effort or CHE or “entertainment”.