The battle over whether to ban advertising of prescription drugs direct to consumers is about to heat up again in Parliament. Donna Chisholm reports.
“I didn’t know it was nerve pain and that I wasn’t treating it properly,” the voice-over continued. “So you should talk to your doctor about your pain and get it diagnosed. You could be prescribed a newly funded medicine that specifically treats nerve pain. Find out if you’ve been suffering from nerve pain and help get your smile back. Ask your doctor about getting a newly funded medicine and treat your pain properly.”
The ad did not mention the name of the Pfizer product being promoted, but it was a drug called pregabalin, the effects of which are so rapid that it’s increasingly being linked internationally to misuse and addiction. Pregabalin was originally marketed as a treatment for epilepsy, but after its patent for that condition expired, nerve pain – for which it gained a secondary patent – soon became its main market, which netted about US$5 billion a year in worldwide sales. The drug’s price had risen more than 163% since 2012.
The problem was, as a UK Supreme Court decision in November 2018 found, the company didn’t have the evidence to prove it worked. “More than a bare assertion or mere possibility of therapeutic efficiency is required,” a majority of the Supreme Court judges wrote when ruling against Pfizer’s patent for nerve pain.
But thanks in part to New Zealand allowing direct-to-consumer advertising (DTCA) of prescription medicines – one of only two countries in the world to do so – the cat is not only already out of the bag, but has also gone on to have several litters of kittens. Since the campaign, which ran after Crown drug agency Pharmac decided to fully fund the medicine from May last year, nearly 16,000 people have been prescribed pregabalin, the majority for “neuropathic pain”.
There are two reasons that Pfizer’s Family Health Diary ad to consumers is so problematic, doctors and academics believe. The first is its “infomercial” tone, says psychiatrist and researcher David Menkes of the University of Auckland, which leads viewers to believe it’s not an ad at all, but some sort of public health message. “These things are presented very much like, ‘Hey, this is something for you to think about that you might benefit from.’”
And yet, he says, this is a “high-risk” prescription-only medicine that can have serious side effects and for which drug seekers have developed a taste. “There is certainly an appetite for this drug out there and it does have a street value and it’s sought by people who want it for not just therapeutic purposes.”
The second problem is that images in the ad imply pregabalin might be useful for any bad back. The only sort of back pain for which it should be prescribed is sciatica, in which pain radiates down the legs. Even then, though, research suggests it’s not all that effective, either. In 2017, an Australian randomised controlled trial, reported in the prestigious New England Journal of Medicine, found pregabalin didn’t significantly reduce the intensity of leg pain associated with sciatica or improve other outcomes when compared with a placebo, but the incidence of adverse effects, including dizziness, was significantly higher in the pregabalin group.
The Listener approached Brandworld, the advertising company behind Family Health Diary, for an interview about the slot, which is the single biggest advertiser of medicines, including over-the-counter products, based on Nielsen figures. After initially agreeing to an interview, executives changed their minds the day after we asked for the screening dates of the pregabalin advertising.
University of Auckland pharmacy teaching fellow Rhys Ponton, who is researching pregabalin prescribing and wrote a paper in the New Zealand Medical Journal in July last year highlighting the potential for addiction and misuse of the drug, says doctors need to be “acutely aware” of those risks, particularly if patients have a history of drug or alcohol misuse that may make them more susceptible.
When pregabalin was launched in the UK, it took off because it was a non-opioid and anyone could prescribe it – as is the case here – before it was linked with misuse and overdose deaths in combination with other drugs. Eventually, it was made a controlled drug, restricting its use. If it was a controlled drug in New Zealand, Ponton says, Pfizer would not have been able to advertise it directly to consumers. The paper said a Cochrane review found that 18-28% of patients needed to stop treatment because of adverse events.
But it seems many prescribers are failing to heed those warnings here. And although pregabalin is seen as an alternative to a related drug, gabapentin, which has slower absorption, the overall market for both drugs has grown, to the point where more than 52,000 people are now taking one or the other. “My fear is that it will be a repeat of the benzodiazepine story, with another generation addicted to a dangerous drug,” says Les Toop, a professor of general practice and head of the University of Otago’s Christchurch-based Department of General Practice and a vocal opponent of this country’s DTCA laws for 20 years.
For Toop and other critics of New Zealand’s permissive regime for prescription drug advertising, the pregabalin case highlights everything that is wrong with our law because it accelerates demand for a drug that might not only be relatively ineffective but also actually cause harm. Now, that legislation is back on Parliament’s agenda with the planned overhaul of the nearly 40-year-old Medicines Act in the Therapeutic Products Bill, a draft of which was released for consultation late last year.
The draft bill allows the advertising status quo to continue, but Health Minister David Clark has signalled a willingness to strengthen regulations relating to the accuracy of the statements made in ads. That’s not good enough for Menkes and Toop, for whom only a ban will do. Says Menkes: “We know industry self-regulation is ineffective, and evidence indicates that government regulators can’t do it, either, partly because there is just too much work to do but also the time frame of ad campaigns is often shorter than the time it takes to adequately review and correct misleading statements. They have often moved on to another strategy, another product. It’s a thankless task, very resource-intensive and demanding, and I don’t think New Zealand should buy into a model that has been tried and clearly failed in North America.”
Pivotal to DTCA opponents’ hopes will be the influence on his National Party colleagues of Whangārei MP Shane Reti, a GP who is deputy chair of the health select committee and is lobbying for a ban. National Party opposition to a ban has scuppered previous attempts to change the law.
Reti told the Listener the wording in the draft bill was not a preconceived view that DTCA should continue. “If we’re going to ban it, put up the hypothesis that it should remain and therefore compel really forceful arguments to talk it down. That would be my guess as to the way it’s been framed.”
Clark declined to be interviewed for this story, but in a statement said the Government had heard the public’s concerns about DTCA and it was one of the key issues he was considering. “I’m not going to pre-empt our decisions by making comment now.” However, he said he was aware of the wide range of views, including those of many health practitioners, that DTCA risked being misleading. “We also know others think DTCA encourages people to engage with their health practitioner to discuss health issues and seek appropriate treatment.”
He said he would speak more about DTCA when he had made decisions and taken them to Cabinet. A spokesman for the minister believed that was likely to happen before the end of the year.
As the only still-prescribing doctor in Parliament and a GP for 30 years, Reti says DTCA causes increasing pressure on him and other physicians to prescribe medicines people had seen on television that weren’t appropriate for them, or that medicalised normal ageing. These patients were sometimes the “worried well” who took the time and resources that would be better directed elsewhere. The National caucus hasn’t discussed the draft bill and won’t until it is introduced.
In 2017, drug companies spent $5.5 million advertising prescription-only medicines in New Zealand. Although that’s a sizeable sum, it’s dwarfed by the ad spend on over-the-counter pharmacy-only medicines ($42.4 million) and natural products ($30.3 million). Asthma drugs featured prominently, as did erectile-dysfunction treatments, before they became products that pharmacists could dispense without a prescription.
Antidepressants have featured as well, and Menkes says he’s encountered dozens of patients over the years who’ve responded to these ads and been prescribed the drugs but who have “run into trouble of various sorts, including suicidality, aggression, intolerance of alcohol and withdrawal syndromes”.
But wouldn’t all this harm to patients be avoided if doctors, when asked for advertised medicines, simply said no? It’s not that easy. “Sometimes, it’s easier to acquiesce,” says Toop, who believes doctors are also “hoodwinked” by the pharmaceutical industry into believing the drugs are better than they are. And when new drugs are marketed, it’s often before the longer-term evidence of harms and ineffectiveness becomes clear. “It’s reasonable to say, ‘Well, Medsafe let it in so it must be safe, and Pharmac funded it so it must be okay. I wouldn’t have chosen it, but okay.’
“Am I going to have someone come and ask for something I wouldn’t have chosen for them and have a 20-minute discussion or longer after which they leave somewhat grumpy. They took a half day off work to come in and get something, they didn’t get it and it’s cost them $50 on the way out. You have to remember how many medicines there are and how grey some of the literature is and how much time they’ve got to spend looking at this stuff.”
Increasingly, though, doctors are declining visits from drug reps, and are signing up to an independent drug evaluation and education programme that Toop co-founded in Christchurch and is now used in seven other places around the country, including Auckland’s ProCare-run practices.
ProCare clinical director Dr Allan Moffitt says doctors have to take drug company advice about a product “with a degree of cynicism” and verify it independently. “We know it has an impact. If you have a visit from a drug rep, prescribing for that particular item [that they were promoting] goes up. Whether it be the reminders in the form of the stationery, pens or freebies given out is unclear, but there is a clear bias in all of that and I think it’s simply what is top of mind for people.”
GPs might get specific requests about once a week or more for a drug they’ve seen advertised. “Even though we are professional and ethical, when you have a patient coming in saying, ‘I want this drug,’ there is increasing pressure for you to say, ‘Okay, we’ll give that a try.’”
Moffitt, who works in South Auckland, says his patients often can’t afford the new drugs, which attract part-charges. But he has had some patients asking for an asthma inhaler that’s been advertised. “You sit down and explain to them that what they are on is the same stuff or just as good.”
Out of step
The New Zealand Medical Association now supports a ban on DTCA – a shift from its position in 2000 when it said it “does not oppose DTC per se but it is opposed to advertising that interferes with the doctor/patient relationship and advertising that is emotive or manipulative”. It said then it wouldn’t be opposed to regulations surrounding advertising being tightened.
“Since that submission, we have not seen any of the argued benefits of DTCA,” says chair Kate Baddock, a Warkworth GP. “There is nothing good about it. People come in saying, ‘I think this is the medicine I need,’ and you then have to unpick why they think that.”
A good example was proton-pump inhibitors such as Losec being sought and prescribed for indigestion. “Indigestion is a really common problem and it only rarely denotes underlying disease. And unless you have underlying disease, inhibiting the production of acid, which these medicines do, is not necessary. A regular antacid just coats the stomach and stops it being a problem.”
The US is the only other country with such a permissive advertising regime for prescription medicines, which puts New Zealand out of step with the rest of the world, Baddock says. She and other doctors the Listener spoke to rejected the argument of Medicines New Zealand, a lobby group representing pharmaceutical companies, that DTCA increases health awareness, encourages patients to act on undiagnosed or poorly managed conditions, improves their compliance with medicines and makes them feel better about medicines when they’ve been involved in the decision-making.
In a fact sheet, Medicines New Zealand referenced those claims to a 2003 Massey University paper, “Dogma, doubts, diversity and diversion: Perspectives from the medical professions regarding the impact of the promotion of medications direct to consumers”. The paper concluded there was no evidence to suggest a ban on DTCA was justified and there were clear benefits to the practice. It added there was a clear need for ads to provide balanced information to enable patients to be better informed about their condition and its treatment.
However, the researchers also said consumers strongly agreed that information about prescription medicines should come only from a doctor or pharmacist, that ads did not give enough information about possible risks, that they made the medicines seem better than they were and were profit driven, and that they created needs in patients that were not justified.
Medicines New Zealand general manager Graeme Jarvis says there is no evidence DTCA is causing overprescribing or is a waste of money. “I’ve seen no evidence of a blowout of anyone’s meds budget, or people having to buy these medicines out of pocket, because most of them are covered by Pharmac, which, in real terms, has had a decrease in budget.” He says there is nothing to suggest DTCA is causing “issues around community or personal health”.
DTCA critics point to two infamous cases, which involved the anti-inflammatory Vioxx and weight-loss pill Reductil, and say the industry’s self-regulatory processes approved ads for both products here before they were withdrawn by manufacturers or banned because of the increased risk of heart attacks and strokes. Vioxx was withdrawn in 2004 and Medsafe revoked consent for Reductil in 2010.
Jarvis says regulatory processes have tightened significantly since then. “The products my members advertise are for serious, chronic and sometimes life-threatening conditions such as diabetes, chronic obstructive pulmonary disease and asthma, and also vaccinations. They are well grounded and researched and there is no targeting of the worried well.”
All advertising has to comply with the Medicines Act 1981, the Medicines Regulations 1984, Medsafe’s Guidelines on the Regulation of Therapeutic Products and the Advertising Standards Authority’s Therapeutic and Health Advertising Code. Every ad for a prescription medicine also has to be screened by the Therapeutic Advertising Pre-vetting Service (TAPS) to ensure all statements it make are “100% accurate”. “Companies don’t just say, ‘We are going to do an ad,’ and put it on TV or in a magazine and away we go. It’s not the Wild West,” says Jarvis.
No public drive for a ban
It is likely that it is precisely because of those rules, though, that advertising often goes the other way, and makes few if any particular claims, other than highlighting a broad condition such as nerve pain and exhorting viewers to ask their doctor if a particular medicine is right for them.
Toop says, in some cases, the advertised condition doesn’t even exist, as happened with the promotion of a medicine called Detrusitol for “overactive bladder” in the early 2000s. That, too, featured on Family Health Diary at the time and the ad was fronted by popular television personality Jude Dobson. “Ever wondered why there’s always a queue outside the ladies?” she asked. “Well, it could be because many New Zealand women suffer from a condition known as overactive bladder. If you’re going to the toilet more than eight times a day, or getting up more than twice a night, you may have an overactive bladder … Many women put up with the problem, some wearing pads, not realising there is an effective treatment such as Detrusitol available.”
“Overactive bladder”, however, was a created disease. Doctors knew it as “urge incontinence” – something that probably made patients reluctant to seek help because of shyness or embarrassment. But the rebranding shifted the narrative – identifying a “new” condition that didn’t imply age or incontinence, but included people who just wanted to go to the toilet less often. The campaign grew the worldwide market for the drug from US$40 million in 1997 to more than US$800 million in 2001.
But Toop says a later Cochrane review showed Detrusitol did little. “It basically works out that you would go to the toilet once less every second day – that’s how minimal the reduction is.” But he says Detrusitol is a type of drug known as an anticholinergic, a group associated with increased risk of dementia and glaucoma, which causes side effects including dry mouth and constipation. “The effect is greater the older you are and the longer you take it, and in ‘overactive bladder’, middle-aged and older women are the target.”
Lindsay Mouat, chief executive of the Association of New Zealand Advertisers, says that less than 0.3% of all advertising in New Zealand is for prescription medicines or associated health campaigns, and from 2016-18, there were fewer than 10 campaigns a year on average.
Ads for prescription drugs have attracted just 11 complaints in the past five years. Mouat says responsible advertising of medicines “plays an important part in our nation’s health”, plus there is no public drive to have DTCA banned. With the ideal doctor-patient relationship being a partnership, he says, patients should be able to choose what medical treatment they want to have.
But if DTCA is so good for us all, why do doctors not want it? A survey of GPs in 2002 found only a third believed DTCA didn’t lead to difficulties in the doctor-patient relationship. Only 3% thought it improved the quality of their prescribing. Said one GP who responded: “Reluctance to prescribe (by me) has been seen as paternalistic, small-minded and power-wielding by one patient who informed me that it was their body, their right to choose and that drug companies used DTCA because doctors don’t have patients’ best interests at heart!”
Another commented: “Although I always resist DTCA-generated requests to initiate or change medications, these patients simply go to another practitioner (in the same practice!) who gives them anything they ask for. I spend a great deal of time explaining the evidence-based option, the non-drug-based options and the options that will lead to better outcomes at lower doses. I don’t know why I waste my breath!”
Mouat believes that antipathy might be partly the result of the changing doctor-patient relationship, which he believes some doctors are struggling with. “My parents treated their GP almost like a god. You never questioned, you did exactly what you were told. The relationship was almost patriarchal, but the world has changed a lot. People want a lot more involvement in medical treatment and health generally.”
DTCA is only a small part of where people get their information about medicines, behind “Dr Google” and family and friends. “Patients are more frequently arriving in the surgery with some level of information already. So, is a good relationship between doctor and patient essentially the GP saying ‘this is the treatment’ or is there an informed discussion? The genie is out of the bottle and you can’t put the cap back on.”
Asked whether it was wise for a potentially addictive painkiller to be advertised in a Family Health Diary format, Mouat said the drug was Medsafe-registered and Pharmac-funded, and the important thing was that it could potentially bring patients with ongoing pain back to the doctor to ask whether they were on the correct treatment or if there were other possibilities. “It’s not like you can go and buy it; you have to have it prescribed.” He says New Zealand’s DTCA cannot be compared with the US regime because of the regulations and independent vetting required here. “What we have is very, very different to that model and I would never endorse what happens in the US. I would much rather provide information in our relatively controlled environment than in the Wild West of Dr Google.”
More harm than good?
At the Council of Medical Colleges, Dr Derek Sherwood is the clinical leader of the Choosing Wisely NZ campaign, which aims to reduce overprescribing, over-testing and over-treatment. “One of the big issues for us is that generally our level of health literacy in New Zealand is not wonderfully high, and it’s certainly much lower in some disadvantaged groups.
“We know that the conversation between health professionals and patients is often not ideal and we have evidence that Māori and Pacific patients don’t feel as engaged in decisions about their health care as other people, so there are a lot of things we could be doing better.
“There has always been a debate about whether DTCA is providing health information and raising health literacy or whether it’s misleading and biased and making it more difficult for patients to have good shared decision-making with their health professionals.”
Canada and South Africa allow “reminder” drug ads, which include only the brand name of the product but no reference to any health claims or hints about the way the product is used. They also allow ads that discuss a health condition and suggest viewers ask about an unspecified treatment.
Dee Mangin, director of the University of Otago Primary Care Research Group and a chair in family medicine at McMaster University in Canada, says she’s uncomfortable even with that more-restricted advertising. “They are quite subtle and work in the same way, showing images of the brand and why you might use it.” Canadians can also access a lot of “cross-border” advertising in the US.
For advocates of a ban, such as Mangin and Toop, the review of the legislation represents what could be the last chance in their lifetime to stop DTCA. “Every time they have had a round of public submissions on this, they’re weighted in favour of banning it, but they never have,” says Toop. “This is a once-in-a-generation opportunity to get it right.”
‘It’s an equity issue’
Minorities and the elderly are inordinately influenced by medicine advertising.
Medicine ads go through the Therapeutic Advertising Pre-vetting System (TAPS), but in a paper in the New Zealand Medical Journal published in June, academic psychiatrist David Menkes, from the University of Auckland, and Joel Lexchin, an emeritus professor of health policy and management at York University in Toronto, Canada, argued regulation doesn’t work and concluded DTCA should be banned.
“It is unrealistic to expect that a revised regulatory system in New Zealand could ensure that commercially driven DTCA can serve the public interest by presenting realistic and unbiased drug information.”
They said the ads are more likely to affect vulnerable people with poorer health status who are older, ethnic minorities and those who are less educated and have lower incomes. Christchurch professor of general practice and leading DTCA critic Les Toop agrees. “It’s an equity issue. When weight-loss drug Xenical was advertised in the early 2000s, he says, the campaign was targeted at Māori and Pacific people. “We got stories from our survey to GPs of patients saying the whole whānau was going without new clothes so grandad could go on it.”
Playing a lung game
Drug makers are targeting their advertisements at diseases of the lungs.
The list includes:
- Breo Ellipta (inhaler for asthma and (COPD))
- Silvasta (erectile dysfunction)
- Viagra (erectile dysfunction)
- Ventolin (inhaler for asthma and COPD)
- Lantus Solostar (long-acting insulin for diabetes)
- Gilenya (multiple sclerosis)
- Symbicort Turbuhaler (inhaler for asthma and COPD)
- Ultibro (inhaler for COPD)
- Spiolto (inhaler for COPD)
- Norflex (muscle relaxant for pain)
- Seebri Breezhaler (inhaler for COPD)
- Circadin (melatonin tablet for sleeping disorders)
- Eltroxin (thyroid hormone for hypothyroidism)
- Ovestin (hormone replacement therapy for women)
- Rex Medical inhalers (asthma, COPD)
- Viekira Pak (treatment for hepatitis C)
- Duolin inhaler (COPD)
- QVAR (inhaler for asthma/COPD)
- Ferinject (iron deficiency anaemia)
This article was first published in the November 9, 2019 issue of the New Zealand Listener.