A few months ago, celebrity Kim Kardashian promoted a prescription morning sickness drug, Diclegis. The pharmaceutical company responsible promptly got in trouble for violating the United States’ federal drug promotion regulations.
As far as the Food and Drug Administration (FDA) was concerned, the problem was not the promotion itself, but that Kardashian neglected to mention the drug’s possible side effects, such as drowsiness. Nor had she said that Diclegis was not approved for certain women with excessive and prolonged vomiting.
The FDA would have found the promotion acceptable if the warnings were included. The ad would have been allowed in New Zealand also. Australia, however, bans all direct-to-consumer advertising of prescription-only medication.
Pharmaceutical companies can use prescription medication ads to mislead an unwitting public for the sake of profits. The ads can undermine the integrity of doctors who may feel pressured to prescribe medication that isn’t the best treatment for their patient.
The US and New Zealand are the only two countries in the Organisation for Economic Cooperation and Development (OECD) to allow such advertising. But in Australia, pharmaceutical companies still find legal loopholes to promote their products.
Laws in New Zealand
New Zealand law requires advertisements of prescription medication directly to the public (as opposed to targeting medical professionals) to contain minimum product information. This includes recommended use, adverse effects, details of the advertiser and the statement “ask your doctor if (the drug) is right for you”.
Advocates argue these advertisements inform patients about products they may be prescribed. They say this leads to better communication between doctors and patients, as well as better health outcomes.
Opponents say emphasising a product’s positives (as advertising does) leads to unrealistic expectations. Patients might be encouraged to ask for a medication that isn’t the most appropriate treatment for them. And the increased demand for branded medication could be costly to the health system.
Medication for people with a psychotic disorder, such as schizophrenia, has been marketed directly to patients in mainstream media and at bus stops in New Zealand.
Prime-time television commercials typically show families before and after their loved one is medicated with drugs such as antipsychotic Risperdal Consta (risperidone), and the difference it makes. These commercials don’t present any additional therapy that could be used. They show health care professionals endorsing the product.
While Risperdal Consta is not the only prescription medication advertised directly to the New Zealand public, the additional challenge here is the potential vulnerability of the patients who may need this type of medication.
Arguably, the risks are amplified when these ads are directed at vulnerable people, such as those with mental health issues.
Advertising in Australia
In Australia, advertisements for therapeutic products are subject to the Therapeutic Goods Act and the Competition and Consumer Act. Advertisements of medication or other therapeutic products directed at consumers must comply with the Therapeutic Goods Advertising Code.
Advertising prescription medicines to health professionals is allowed. This is self-regulated by Medicines Australia. But advertising this medication directly to consumers is prohibited.
In 2000, the Australian government commissioned a review of its Drugs, Poisons and Controlled Substances Legislation to explore deregulating direct-to-consumer advertising. The review found it was unlikely to be in the public’s interests.
But pharmaceutical companies have, on occasion, found ways to evade legislation by exploiting loopholes.
For instance, they use “awareness campaigns” to indirectly promote their products. Advertisements don’t name a drug directly but provide general information about diseases and treatments and encourage consumers to talk to their doctor.
Its Code of Conduct has a number of weaknesses. It relies mostly on spontaneous complaints and voluntary compliance by pharmaceutical companies. This means pharmaceutical companies may advertise directly to consumers until a complaint is made.
In 2002, the company Sanofi-Synthelabo advertised its hypnotic drug Zolpidem in the Qantas airline magazine. After a complaint was lodged, Sanofi-Synthelabo was found to have breached the code and fined $A50,000. But it is unknown how many travellers had bought or asked to be prescribed the drug after reading the magazine.
More harm than good
Direct-to-consumer advertising contributes significantly to profits of pharmaceutical companies. Despite what advocates of such ads might say, the priority is likely to be profits, rather than provision of information. To attract sales, companies can misrepresent the benefits of their products and downplay risks.
In New Zealand, support is growing for direct-to-consumer advertising in the name of “consumer choice”. This is concerning as these new and expensive branded medications may, at best, have only marginally better results than their generic counterparts.
While a need for information about medication clearly exists, there is a more immediate need to protect the integrity of medical professionals who are being pressured to prescribe certain medication.
A study of 3,200 general practitioners in New Zealand revealed nearly 70% (or 35% of all GPs in New Zealand) reported having felt pressured by patients to prescribe advertised medicines. Such pressure may prevent doctors from considering treatment alternatives.
Another study showed doctors felt direct-to-consumer ads could be detrimental to their relationships with patients. Patients may also engage in “doctor shopping” to get the prescription they want.
Health professionals and politicians in Australia and New Zealand must hold the pharmaceutical and advertising industries to account on how they market prescription medicines.
Even in the US, thanks in part to Kim Kardashian, questions are being asked about the “serious problem” of direct-to-consumer advertising.