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
I object to advertising of prescription drugs full stop! Why? What’s the reason for advertising? To sell more product/s. The benefits of one drug over another should be driven by the successful and safe trials of the drugs – not be patient driven due to overinflated promises via TV or other advertising. It’s also going down the US path, and I’m against anything that remotely resembles the disgraceful so-called health industry in the US.
Having been in the United States I can say that the advertisement in question is a direct replica of the actual advertisement used to advertise directly to consumers in the US including the stretch against the tree by an overweight male trying to look fit. Pretty sure the colours on the tracksuit and the choice of leg stretch are also a replica. The only thing missing is the drug name and drug company. You can bet there is a further massive marketing campaign directly to doctors going on at the same time to bring together the “query your doctor” and “prescribe to your patient” themes.
The marketing budgets for these drugs are obscene. Finding loop-holes to link brands by some of the devices mentioned shows contempt to the spirit of the legislation. While in the US they use some archaic loophole to advertise drugs – at least they are required to state side-effects. “May cause suicidal ideation” might not sound so good in the battle against the nicotine monster.
I’ve just read Side Effects by Allison Bass, a journalist from the Boston Globe. Interesting to get background on the FDA move (in the Bush Snr. Era) to a user pays model (as the TGA is in Australia..wtf?) and the vast sums of money Big Pharma is funnelling into these organisations, and of more concern directly to the people sitting on these committees – just sign a conflict of interest waver.
The way people killed and harmed themselves after commencing Prozac (and other SSRIs) are horrific. I was reading thinking – how terrible but that happened 20 years ago in the US… Pretty naive of me to think it has been different here – hundreds of Australians died from Vioxx. Had the FDA spent double the time approving the drug (Pharma pushed the FDA to halve it’s approval time) would the result have been different?
The side-effects of SSRIs such as Prozac, Zoloft and Paxil. Safeguarding profits by maintaining low risk profiles is abhorrent. There’s far too many things I found upsetting in this book to mention here – read it.
DAVID ROBERTS – Hi David, did you buy the book at the usual outlets or from the internet? My library is pretty good too, I might try there (pensioner’s income?)I heard the other day, that with the health care debate currently going on in the US, there’s about 6-7 lobbyists for every congressperson? I wonder what percentage are from drug companies? For more insight Michael Moore’s ‘Sicko’ is a real eye opener (www.freedocumentaries.org – just go down the right hand side and you’ll see it – some great documentaries on that site). Who’d want to be poor and really sick in the US. I read an article that stated, that between 2000 – 2006? 135,000 americans died due to lack of health insurance. Obscene isn’t it? The debate re the cost of a decent health care program; accusations of socialism??? etc is really tragic. If they protested over the anticipated $2-3 TRILLION spending on the illegal invasion of Iraq & Afghanistan, I’d have some sympathy. A decent health system(with the necessary checks & balances re drugs and drug companies?) would cost heaps less(several billion per year) by comparison!
A woman who worked at a Peoples Medical Centre in my area made a wall clock out of those colourful pens you see in doctor’s surgeries and chemist shops; all from drug companies and the like. It was like a wall mural – quite large! Amazing! It was very sobering to see the numbers and colours of these ‘give aways’ from drug companies?
It may be too much to hope that this will be fixed by discussions with industry and with the regulatory body (the TGA) fighting regulatory capture as previously mentioned on Croakey http://blogs.crikey.com.au/croakey/2009/09/11/open-letter-to-mark-butler-on-weak-dysfunctional-and-inconsistent-regulation-of-health-industry-marketing/. Also see Marcia Angell’s excellent book: The Truth about the Drug Companies http://www.nybooks.com/articles/17244 .