Adverse drug events increase

A new study shows the number of drug-therapy related deaths and injuries reported to the US Food and Drug Administration (FDA) nearly tripled between 1998 and 2005.

A researcher at Wake Forest University School of Medicine in the US and colleagues reviewed serious and fatal drug events reported in that eight-year period to the FDA by consumers, health professionals and drug manufacturers, and found that serious adverse drug events increased 2.6-fold, from about 35,000 to nearly 89,000, and adverse drugrelated deaths increased 2.7- fold, from about 5,500 to more than 15,000.

The study is reported in the 10 September issue of Archives of Internal Medicine.

The FDA receives these reports of serious adverse drug events through its Adverse Event Reporting System, better known as MedWatch.

The study also reported serious events increased four times faster than the total number of outpatient prescriptions during that period.

“This marked increase of serious injuries from drug treatment is of great concern,” said Curt Furberg, MD, PhD, professor of public health sciences at Wake Forest University School of Medicine in the US, and a co-author of the report. “It shows current efforts to ensure the safety of drugs are not adequate, and that physicians and patients are unaware of these risks.”

Furberg has previously called for far-reaching changes in drug safety regulation, including expanded authority for the FDA, higher priority for drug safety and new systems to monitor drugs once they are approved by the FDA.

“The study found that a relatively small number of drugs accounted for the most reported serious adverse drug events,” said Thomas J Moore, AB, of the Institute for Safe Medication Practices (ISMP), and the lead author. The authors of this study took into account several factors that might influence their findings.

“We saw no evidence that doctors and patients had become more active in reporting events in some across-the-board fashion,” said Furberg. “We also tried to eliminate ‘noise’ in the reporting system, by excluding reports from more than 14 days after a drug was withdrawn. In addition, we excluded events that were not serious, and foreign reports to focus on US risks.”

Human-animal embryos

BBC News online reports that British regulators have agreed in principle to allow human-animal embryos to be created and used for research. But scientists wanting to use hybrids will still need to make individual applications, the UK-based Human Fertilisation and Embryology Authority (HFEA) said.

Lyle Armstrong, of Newcastle University, who has applied to the HFEA for a licence to pursue such research, told the BBC: “It's not our intention to create any bizarre cow-human hybrid, we want to use those cells to understand how to make human stem cells better.”

The HFEA said in a statement: “The decision on how the HFEA should approach the licensing of human-animal hybrids and chimera research has presented a particular challenge as this research is so novel in legal, scientific and ethical terms.

“In order to ensure that the Authority was able to make an appropriate and reasoned decision, we needed to ensure we had a comprehensive and robust evidence base as a foundation for that decision.

“Having looked at all the evidence the Authority has decided that there is no fundamental reason to prevent cytoplasmic hybrid research. However, public opinion is very finely divided with people generally opposed to this research unless it is tightly regulated and it is likely to lead to scientific or medical advancements.

“This is not a total green light for cytoplasmic hybrid research, but recognition that this area of research can, with caution and careful scrutiny, be permitted.”

The HFEA points out in a consultation paper published earlier this year that cytoplasmic hybrid research can advance research into stem cells which could lead to new therapies for diseases such as Parkinson’s and Alzheimer’s.

Updated GOLD report for COPD

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) has released new standards for the diagnosis, management and prevention of chronic obstructive pulmonary disease (COPD). The latest recommendations emphasise the importance of proper diagnosis, assessment of the disease’s severity, and the need for a better understanding of comorbidities to improve treatment of disease.

The GOLD report is updated annually online, but this is the first “complete makeover” since its initial publication in 2002. “This is an absolutely up-to-date summary of all the available evidence on the diagnosis, management and prevention of COPD,” said Klaus Rabe, MD, PhD, lead author of the report.

The executive summary of the updated GOLD report appears in the second issue for September of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

According to the report, COPD is the fourth leading cause of death in the US and is projected to be fifth worldwide by 2020. It currently affects 15% to 25% of adults over the age of 40, says Dr Rabe, of the Department of Pulmonology at the Leiden University Medical Center in the Netherlands. Yet in spite of the prevalence and seriousness of COPD as a public health threat, COPD is relatively unknown and ignored by the public as well as by health officials.

The new standards reflect the evolution of current scientific and medical thought. “One of the most important points is that we now say COPD is preventable and treatable,” said Dr Rabe. “There are steps we can take to prevent it, and it is no longer viewed with therapeutic nihilism.” The guidelines can be downloaded here:

Malaria WARNing

The World Antimalarial Resistance Network (WARN) – a global network to monitor drug resistance and guide malaria treatment and prevention policies – is being launched.

WARN aims to initiate a globally co-ordinated effort to tackle the disease, which is estimated to kill between 1 million and 2.7 million people every year. The initiative comes on the back of four related papers published in Malaria Journal which make the case for the establishment of the global network.

WARN will facilitate worldwide monitoring and characterisation of drug resistance, particularly that to the latest generation of antimalarial drugs, artemisinin-based combination therapies (ACTs).

The network will consist of four linked, global, openaccess, web-based databases containing four kinds of data:

- Clinical drug efficacy
- In vitro response of malaria parasites to drugs
- Prevalence of molecular markers of drug resistance
- Pharmacological properties of drugs in different groups of patients

The databases will include freely available tools to make adding information straightforward, and to give researchers the opportunity to analyse and use information from the databases in a variety of ways.

For more information visit:


The US National Institutes of Health (NIH) and NASA have signed a Memorandum of Understanding to enable American scientists to utilise the International Space Station to conduct research about human health and diseases.

Elias Zerhouni, MD, NIH director, said: “The station provides a unique environment where researchers can explore fundamental questions about human health issues – including how the body heals itself, fights infection, or develops diseases such as cancer or osteoporosis.”

Compared with the Earthbound laboratories, the facility at the station provides a virtually gravityfree environment where the cellular and molecular mechanisms that underlie human diseases can be explored. For example:

– Since the beginning of the space programme, researchers have known that prolonged periods of weightlessness cause bones and muscles to deteriorate. The station provides a stable platform on which scientists can study the molecular basis of these effects, for the eventual benefit of people who suffer from weak, fragile bones or from muscle-wasting diseases.

– When people escape the gravitational pull of Earth, their brains also need to adjust to the sensation of weightlessness. Understanding how elements of the brain in space compensate for the absence of sensory input that gravity provides on Earth holds promise for people who suffer from balance disorders.

– Other biologic systems in humans and in other organisms also are affected by microgravity. A biologic explanation for observed changes in microbe infectivity and human immunity during prolonged space travel could offer new hope to people who have difficulty fighting infections on Earth.

Mobile phone one-metre rule

Mobile phones should come no closer than one metre to hospital beds and equipment, according Dutch research published in the online open access journal, Critical Care. Scientists demonstrated that incidents of electromagnetic interference (EMI) from second and third generation mobile phones occurred at a mere three-centimetre distance.

In this particular study, the research team examined the effects of General Packet Radio Service (GPRS) and Universal Mobile Telecommunications System (UMTS) signals on critical care equipment such as ventilators and pacemakers. Almost 50 EMI incidents were recorded; 75% were significant or hazardous. Hazardous incidents varied from a total switch off and restart of mechanical ventilator and complete stops without alarms in syringe pumps to incorrect pulsing by an external pacemaker.

The second generation (2.5G) GPRS signal caused the highest number of EMI incidents at over 60% whereas the third generation (3G) UMTS signal was responsible for just 13%. EMI incidents also occurred at a greater distance with GPRS with a hazardous incident even at three meters.

While first generation mobile phones are used mainly for voice transmission, 2.5G and 3G phones enable internet access, sending and receiving data. They entered the market, however, with little proof regarding their safe use in the medical environment.

Dr Erik van Lieshout, lead researcher from the Academic Medical Center, University of Amsterdam, said: “Our work has real implications for present hospital restrictions of mobile phone use in patient areas.”

“It is unlikely that mobile phone induced EMI in hospitals will be eradicated in the near future so the one metre rule currently in place should continue, as it is relatively safe,” commented Dr van Lieshout.


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