Regulation report reveals drug approval delays
THE first report from the Independent Review of Medicines and Medical Devices Regulation
, released by the Australian Government last week, makes 32 recommendations on regulatory frameworks for medicines and medical devices, as well as on access to unapproved therapeutic goods in special circumstances. The expert panel that conducted the review said it was “mindful of the technological change and innovation that has occurred in the changing health care environment” since regulatory frameworks for medicines and medical devices were first introduced. In the executive summary of the report, the panel members wrote that they were “mindful of the increasing globalisation of the pharmaceutical and medical devices industries and the rapid pace of innovation and change within the health care sector”. The report revealed that it had taken between 34 and 467 days longer for some new medicines to gain approval in Australia than in the US or Europe because of drug company delays. The panel said they had “identified opportunities to enhance the regulatory frameworks for medicines and medical devices” to ensure the future of the Australian National Regulatory Authority (NRA). “Continuing to harmonise the Australian regulatory system with international regulatory frameworks plays an important role in this regard. In identifying opportunities for reform, the Panel has been conscious of ensuring that there is no diminution of protections for the Australian public.” The panel is working on stage two of its review, which will examine the regulation of complementary medicines and report on the regulation of advertising of therapeutic goods. The stage two report is expected to be presented to the government in the near future.
Recurrence risk after stillbirth in first pregnancy
WOMEN who experience an unexplained stillbirth in their first pregnancy are at increased risk of stillbirth in subsequent pregnancies, according to the results of a systematic review and meta-analysis published in The BMJ
. The research included studies published between 2001 and 2014, including five undertaken in Australia. It found data on 3 412 079 women with pregnancies of at least 20 weeks’ duration, with 99.3% of women having had a previous live birth and 24 541 (0.7%) a stillbirth. Women with a history of stillbirth suffered 14 283 stillbirths in subsequent pregnancies (2.5%), but only 0.4% of those without a prior stillbirth. Those who experienced a stillbirth in their first pregnancy were almost five times as likely as women who had had a live birth to experience a stillbirth in their second pregnancy (odds ratio of 4.77). The researchers wrote that the review and meta-analyses represented the first comprehensive synthesis of available evidence on the association between stillbirth and unexplained stillbirth in a previous pregnancy and the risk of recurrence. They said the research added to the body of evidence on stillbirth recurrence, “and can be used to counsel couples who are thinking of conceiving after a previous explained or unexplained pregnancy loss”. An accompanying editorial
said the research findings suggested that “effective antenatal surveillance and intervention for this high risk group may reduce the overall burden of stillbirth”.
MERS information, guidelines available
THE federal Department of Health
has released information, fact sheets and national guidelines for public health units on the Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV). Professor Chris Baggoley, the Chief Medical Officer, has also contacted Australian medical colleges and health agencies, asking them to publicise the international situation regarding the spread of MERS and making them aware of the recommendations for the identification and handling of suspected cases. In an alert to members, the Royal Australasian College of Physicians
said more than 1300 cases of MERS-CoV infection has been diagnosed worldwide, with 85% recorded in Saudi Arabia. Cases in the Middle East had been associated with a 40% fatality rate. The alert said that since the first cases of MERS had been noted, a small number had been recognised in other countries, mostly in the Middle East, but also in France, the UK and the Philippines. All have been exported from the Middle East or can be linked to infection acquired in Saudi Arabia .An outbreak was reported in South Korea earlier this month with sustained person-to-person transmission occurring almost exclusively in health care settings. Professor Baggoley has told the medical colleges that “in alert and well functioning health systems, the risk of transmission is low”. He also emphasised the need to ask about travel to the Middle East in the previous 14 days in all patients presenting with respiratory or influenza-like symptoms, and stressed the importance of keeping the data on non-specific features of the illness in mind.
“Notable advantages” from injectable risperidone
A RANDOMISED controlled trial published in JAMA Psychiatry
, has found the use of long-acting injectable risperidone after a first episode of schizophrenia has important advantages for clinical outcomes when compared with oral risperidone. The trial included 83 patients with onset of schizophrenia within the previous 2 years who were assigned to receive long-acting injectable or oral risperidone. Half of each group simultaneously received either cognitive remediation to improve cognitive functioning, or training in healthy behaviours to improve lifestyle habits and wellbeing. Psychotic relapse and control of breakthrough psychotic symptoms were assessed as outcome measures; the mean follow-up time was 10.2 months, with psychiatric hospitalisations during the study period examined independently of symptom return. The authors found that psychotic exacerbation and/or the relapse rate was reduced in the long-acting risperidone group compared with the oral group. Injectable risperidone was also better at controlling the mean levels of hallucinations and delusions through the follow-up period. The cognitive remediation and healthy-behaviours training groups did not differ significantly with respect to psychotic relapse, symptom control or hospitalisation rates. The authors also found no significant interactions between the two medications and the two psychosocial treatments. Discontinuations owing to inadequate clinical response were more common in the oral group than in the injectable medication group. The authors wrote that the key advantage of long-acting injectable risperidone was apparently the more consistent administration of the medication. They said their results were a “game changer” and highlighted how long-acting injectable antipsychotics early in schizophrenia “can modify the trajectory of the disorder and lead to better long term outcomes”. An accompanying editorial
said that, in the absence of trials of more than 3 years and the potential advantages of dosage reductions in the longer term, physicians still had much to learn as long-acting injectable medications were “extended to being given early in illness and to patients with a better prognosis”.
Colorectal cancer trials gradually improve survival
MORE effective agents and better surgical, medical and supportive care for patients with metastatic colorectal cancer (mCRC) has led to a gradual improvement in overall survival (OS) in the past 20 years, according to research publish in JAMA Oncology
. The systematic review and analysis of 96 phase 3 trials and large (>50 patients) phase 2 trials conducted between 1993 and 2015 found that novel therapies only accounted for a fraction of survival gains in mCRC. The researchers said this finding contradicted “the widespread narrative that improved therapies are primarily responsible for advances”. They found that the OS in experimental arms (EAs) increased at a mean rate of 0.80 months/year, while those in control arms (CAs) improved by 0.63 months/year. Chemotherapy contributed only partly to the gains in OS, with mean improvements in progression-free survival of 0.31 months/year in the EAs and 0.23 months/year in CAs. The researchers wrote that the most important conclusion to be drawn from the analysis was the “indisputable value” of patients enrolling in clinical trials. “The progress made in mCRC in the past 2 decades has been earned through the hard work of rigorous clinical trials conducted by countless dedicated investigators”, they wrote. “And while patients with mCRC can now expect on average to live more than 2 years after the diagnosis, oncologists should not consider this acceptable.” They wrote that future progress would be greater if emphasis was placed on enrolling patients in experimental trials to explore and develop alternative first-line regimens and better second-line therapies.
Depression in children linked to cyberbullying
CYBERBULLYING has been associated with depression among children and adolescents, but evidence of the effect of cyberbullying on other mental health conditions is inconsistent, a review published in JAMA Pediatrics
has found. The authors based their findings on a review of 36 studies examining the effects of cyberbullying via social media. Most of the studies were conducted in the US and included middle and high school students aged 12‒18 years who were mostly female. Facebook was the most commonly used platform, where 89.0%‒97.5% of social media users had an account. The authors found that the median reported prevalence of cyberbullying was 23.0%. Five papers reported inconsistent or weak correlations between cyberbullying and anxiety, while 10 studies found a statistically significant association between cyberbullying and reports of depression. Five studies investigated self-harm or suicide, but the results were statistically insignificant. Only one study used a longitudinal design, preventing any firm conclusions about the long-term effects of cyberbullying. The authors found that the most common reason for cyberbullying was relationship issues, and girls were the most frequent targets. Responses to cyberbullying were usually passive, including blocking the sender and avoiding or ignoring the messages. There was also a pervasive lack of awareness or confidence that anything could be done to prevent or reduce cyberbullying. The authors wrote that the review highlighted the evolution of social media and its creation of an online world that had both benefits and potential harms for children and adolescents. They said adolescents lacked awareness of strategies to cope with cyberbullying, and the research results provided important information to help inform prevention and management strategies, including on the characteristics of targets and perpetrators, reasons for and the nature of bullying behaviours, and how victims react to and manage bullying behaviours.