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| Challenges at the cutting edge |
8-Jun-2010 |
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ETHICS: Deciding when to start prescribing newly released drugs to patients can present an ethical dilemma. By John Kron
BRISBANE GP Dr Camilla Andrews admits she is not an early adopter of newly available drugs. She makes sure she has done plenty of research before deciding whether to prescribe new medications.
“One of the first things I do is call in a drug rep to provide information, which I find is helpful for giving me the limit of the expectations of the benefits that can be achieved by a new drug,” Dr Andrews says.
“But then I also tap into the scientific expertise of the drug rep, rather than just the marketing expertise, and ask for specific studies, particularly those relating to side effects and interactions.
“I attend education events where speakers might be zealots for a new drug, but even they usually talk about the bad aspects as well as the good. To round out all this, I read the [prescribing information] and the National Prescribing Service reports in detail. And, if necessary, I speak with specialists and GPs whose opinions I respect.”
Dr Andrews admits it takes time to gather all this information.
“At best I’m a middle-of-the-road adopter if the outcome of my investigation shows positive results. But if the results are negative, I prefer to wait and see the impact of the new drug in real clinical settings,” she says.
There are plenty of examples to show such caution is warranted. While early adopters of new drugs clearly want to offer the benefits to their patients as soon as possible, the concern is that the drug may end up like Vioxx (rofecoxib), which came onto the Australian market in 2000 but was withdrawn in 2004 because of reports of harm to patients (see box below).
However, Associate Professor Malcolm Parker, a GP and medical ethics lecturer at the University of Queensland, says despite the Vioxx experience, early adopters stand on good ethical ground.
“GPs are faced with making decisions in some degree of darkness regarding the eventual outcome [of the drug’s use]. So it’s reasonable to put your trust in the regulatory process. A new drug wouldn’t come onto the market if it wasn’t regarded as having an acceptably low risk profile,” Professor Parker says.
“Of course that profile may change as the drug is used in real clinical situations, so as more information becomes available, doctors can change their prescribing behaviour,” he says.
Dr Brendan Shaw, chief executive at Medicines Australia, says the Therapeutic Goods Administration, considered one of the top regulatory agencies in the world, does rigorous evaluation and checks of safety and efficacy that can take a year or more before a new drug is put on the market.
“Before PBS listing, a drug has further evaluation and checks of up-to-date information from Australia and overseas, where it often has already been in clinical use for up to three years, so a good amount of information will be available,” he says.
But Dr Peter Mansfield, a SA GP, visiting research fellow at the University of Adelaide and director of a group that campaigns against misleading drug promotion, Healthy Skepticism, says despite the regulatory process, there is evidence that new drugs are more likely than not to turn out to be “lemons”.
Dr Mansfield says a recent study in Prescrire, the French equivalent of Australian Prescriber, found that of 984 new products and indications in the past 10 years, only 2% were a positive advance on older drugs, whereas 12.6% should never have been put onto the market.
“Because of evidence that being an early adopter is more likely to lead to more harm than good, I usually choose not to prescribe a new drug for five years,” he says.
This is the time recommended by the Health Research Group, a US watchdog unit within Public Citizen, an organisation founded by consumer advocate Ralph Nader.
However, the Prescrire study shows that 29% of new products and indications were categorised as “offers an advantage” or being “possibly helpful”, with 51% described as “nothing new”.
Rather than pinning her decision on the odds of being beneficial or harmful, Professor Jenny Doust, a Brisbane GP and professor of public health at Bond University’s faculty of health sciences and medicine, uses a case-by-case approach that depends on the type of evidence in support of each new drug.
“My approach means I can be an early adopter and allow patients not to miss out on the benefits of a new drug, or a late adopter and avoid harms that may be exposed later on,” says Professor Doust, a member of the Pharmaceutical Benefits Advisory Committee.
“The main thing I look for is whether the marketing evidence is predominantly focused on biological outcomes such as blood pressure levels or HbA1c, or whether it is on clinical outcomes such as stroke and heart attacks.”
She says there are examples of drugs that only had good results of biological outcomes when they first came onto the market such as rofecoxib (Vioxx) and rosiglitazone (Avandia), and the clinical outcomes turned out to be harmful.
“But if the studies show benefits for clinical outcomes then I am more confident about prescribing a new drug.”
Professor Parker says just as it may be ethically acceptable to be an early adopter, the same may apply to late adopters.
“It is difficult to argue against being a late adopter if the outcome of the new drug is unknown at the time, as long as the patient is taking an older drug that is safe and has benefits,” he says.
He also dismisses the criticism of late adopters acting as “bystanders”, where they reap the benefits of knowledge about a new drug gained by sitting back and letting other GPs test it on their patients.
“Doctors will inevitably vary in their level of caution and consequent rate of adoption, and in any group there will be a group of later adopters relative to others in the group,” Professor Parker says.
GP Dr Andrews describes herself as “an advocate for my patients and my primary duty of care is for them”.
“I agree that I have a duty of care for the community. But by gathering as much information as possible about a new drug, I am protecting my patients from overenthusiastic marketing and therefore fulfilling my duty of care to the community,” she says.
Reference:
Prescrire 2010; 30 (316):136-42 (translated in Prescrire International 2010; 19 (106):89-94).
PATIENT PRESSURE
BEFORE Vioxx was withdrawn from sale in 2004 it had been the subject of a big media campaign in Australia that started before the drug was launched in late 2000.
This caused some patients to pressure GPs to prescribe Vioxx, raising questions about the influence of patient expectations when GPs are deciding whether to prescribe a new drug.
The University of Queensland’s Professor Malcolm Parker says patient expectations are always a factor in the efficacy of any drug.
“So, if a patient is keen, the indications are appropriate and you’re happy with the evidence of benefit and risk, it’s reasonable to prescribe a new drug,” he says. “If you’re a late adopter, you may resist the patient’s overtures by explaining your position. However, if the patient is still keen, it is ethically more acceptable to prescribe the drug.”
Dr Peter Mansfield, of Healthy Skepticism, says patient preferences are important and a key reason why he sometimes prescribes new drugs sooner than his usual five-year limit.
“However, I tell patients that government marketing approval has a poor track record because of lack of experience with drugs when they are new. The chances are that over the next five years we will learn that this drug does more harm than good, so if avoiding harm matters to you, say no to new drugs.
“Many of my patients end up changing their minds,” he says.
OUT OF TIME, BUT UP-TO-DATE
BEING time-poor often makes it hard for GPs to keep up with the evidence on new drugs.
Professor Jenny Doust, of Bond University, recommends the following qualitative guide to some convenient sources of information:
* Drug representatives and pharmaceutical company-sponsored education events are likely to place more emphasis on benefits than harms.
* Medical colleagues (specialists and GPs with a special interest in drugs) are likely to be independent sources.
* Publications and websites, in particular, the National Prescribing Service (www.nps.org.au), Therapeutic Guidelines Limited (www.tg.org.au) and Australian Medicines Handbook (www.amh.net.au ) are the most independent sources, with the NPS being more up-to-date and containing more relevant information on recently released drugs.
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