Pfizer is running a big marketing campaign for its combination heart pill, Caduet. Medical magazines have been carrying full-page advertisements, advising doctors that “patients will soon be asking about their suitability for combination heart medications”.
The advertisement includes a sample from a consumer advertising campaign, which advises readers to talk to their doctor about a combination heart pill if they’re taking multiple medicines for their heart. The consumer ad incudes a rip-out section to take to the doctor, which carries a Pfizer logo and says “I’d like to discuss my treatment for high blood pressure or high cholesterol. Please advise me if a combination heart pill is suitable.”
This is occurring despite a Medicines Australia Code of Conduct, which complements the Australian legislation that prohibits direct-to-consumer advertising of prescription medicines. However, the code has several loopholes that allow pharmaceutical companies to subvert the ban on DTCA.
Unfortunately, direct-to-consumer advertising of Caduet is not an isolated case.
De facto direct-to-consumer advertising increasingly occurs in the form of “unbranded” advertisements or campaigns about specific diseases and conditions, which do not mention of the name of a specific medicine, but may include the company name or their logo.
Famous examples of unbranded marketing campaigns include the Viagra “Welcome Back Tiger” campaign. Pfizer, the maker of Viagra, simultaneously advertised to GPs and to consumers in popular magazines. The only difference between advertisements was the “omission” of the product name and product information in the consumer version. The tiger character became prominent in subsequent campaigns, making it synonymous with the product.
There are multiple examples of ongoing de facto DTCA campaigns in Australia. For example, Pfizer is currently running the “Master” marketing campaign for Champix (varenicline), a new drug marketed for smoking cessation.
The consumer campaign includes TV, radio, outdoor and online advertising. The “Master” is featured by a pack of cigarettes, “representing the manipulative inner voice of nicotine addiction”. This campaign encourages smokers to seek healthcare professional advice and visit outsmartcigarettes.com, a commercial website listing websites for smoking cessation products such as nicotine replacement product. At the same time, Pfizer is promoting Champix towards doctors and pharmacists and give them promotional leaflets to distribute to their patients.
Wide-scale advertising to the public of new medicines, whose long-term health effects are still unknown, is a threat to public health as two-thirds of the medicines that are withdrawn from the market due to safety concerns have been on that market for less than three years.
While advertising a medicine for smoking cessation such as Champix may seem a laudable objective, Champix is a new drug and as such, may cause severe adverse effects that may only be discovered post-marketing. No surprise, it is actually what happened with Champix.
Since the initial marketing of Champix, medicine agencies around the world have issued stronger and stronger safety alerts. In the United Kingdom, 1241 reports of suspected adverse reactions were received during the first year of marketing, mainly psychiatric adverse effects with headaches, abnormal dreams and nightmares, depressions and depressed moods and suicidal ideations.
In December 2008, the Australian Adverse Drug Reactions Advisory Committee (ADRAC) bulletin stated that they had received 339 adverse reaction reports with varenicline up to October 2008, more than 72% being psychiatric symptoms including depression, aggression, agitation, abnormal dreams, insomnia, hallucination and anger. There have also been reports of suicidal/self-injurious ideation or behaviour.
In July 2009, the US Food and Drug Administration required Champix to carry the agency’s strongest safety warning over side-effects including depression and suicidal thoughts. Despite the new, stricter warnings, the FDA said consumers and doctors still have to weigh the benefit versus the risks when taking the drug. “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, the director of the FDA’s Centre for Drug Evaluation and Research.
Another ongoing DTCA campaign is the Bayer’s campaign on how “low testosterone can take the life out of you” (for example, full-page advertisement in the August 22-23 Weekend Australian Magazine). This campaign encourages men to see their doctors if they have any symptoms such as “lack of vitality, reduced sex drive, mood swings, poor concentration and reduced strength”.
Bayer’s low testosterone campaign is typical of a disease awareness campaign that is used as a strategy to extend the boundaries of illness and to expand markets for new products. In the case of Bayer’s campaign, men are told to view non-specific and common symptoms that may occur in ageing as a treatable disease that could be cured. It is similar to the promotion of hormone replacement therapy (HRT) for menopausal women.
And when you have the “disease”, look out for the drug! A single internet search showed that Bayer was marketing in Australia a range of testosterone products, such as Reandron 1000 and Testogel. The use of testosterone products (androgens) in men outside very limited indications is not a harmless measure.
Severe adverse effects from inappropriate use of androgens include sodium and water retention, oedema, acne, gynaecomastia, impotence, testicular atrophy, priapism, inhibition of spermatogenesis, degenerative changes in seminiferous tubules, impaired glucose tolerance, hypercalcemia, polycythaemia, decreased clotting factors, increased LDL cholesterol, aggressive behaviour, psychotic symptoms, physical and psychological dependence, withdrawal symptoms etc.
The ban on DTCA is related to the ban on direct sales of prescription medicines. It a health protection measure to prevent unsafe and unnecessary medication use. The ban on DTCA is consistent with regulatory aims to protect health and with the National Strategy for Quality Use of Medicines to encourage appropriate medicine use. DTCA may pretend to be information, but its primary objective is to increase sales of one particular medicine without any consideration for the public health issues.
Unbranded product advertising and disease-awareness campaigns are two of the most common forms of DTCA that should not be allowed in Australia if the current regulatory ban was properly enforced.
Over the past 20 years, several complaints have been sent to Medicines Australia about unbranded product advertising and disease-awareness campaigns. To our knowledge, they have never been upheld if the name of the advertised product was not explicitly mentioned in the advertising campaign. Any further complaint to the TGA would just remain ignored because of their absolute “trust” in the efficacy of the self-regulatory system for the control of drug promotion.
In the past few years, the successive waves of international scandals have revealed to a wide public that misleading drug promotion and unethical behaviour of top international drug companies were systemic problems and not isolated cases. The passive attitude of regulatory agencies will have to change if they want to keep the trust of the Australian public.
Parliamentary Secretary for Health Mark Butler recently declared that the government has begun to conduct a complete review of how the relationship between pharma companies and doctors is regulated. We hope that the Australian government will take vigorous steps to enforce the ban of DTCA in Australia including unbranded product advertising and disease-awareness campaigns. We hope that we will regain confidence in the Australian regulatory agencies to achieve what they are meant to achieve: preventing unsafe and unnecessary medication use and protecting the Australian public from the harm of misleading drug promotion.
Dr Agnes Vitry is a member of Healthy Skepticism and Health Action International