Steffen Schulz was completing his PhD in medical neuroscience when he realised he needed more job security than academia could offer. Now, he works as a drug safety manager in his native Berlin.
Originally I was interested in the origin and the development and evolution of life. Then I shifted to questions like ‘why do animals and humans behave the way they do?’
Steffen Schulz
The worst thing that can happen to a person participating in a clinical trial is what’s known as a ‘serious adverse event’, which can describe anything from permanent kidney damage or liver failure to hospitalization or even death. Federal law in the US mandates that researchers conducting trials of drugs or other products regulated by the country’s Food and Drug Administration (FDA) report adverse events on ClinicalTrials.gov, a data repository open to the public. But a new study shows that many of these serious adverse events don’t appear in medical journals, making some interventions seem more favorable than they may actually be.
Reporting online today in the Archives of Internal Medicine, a group of researchers led by Daniel Hartung, a drug safety and policy analyst at Oregon Health & Science University in Portland, looked at how the data reported on ClincialTrials.gov stack up against the results published in the medical literature. The team limited their focus to phase 3 or 4 trials with results reported on ClinicalTrials.gov and completed prior to 2009, to allow sufficient time for the trials’ results to be published in medical journals. Hartung’s group then randomly selected 10% of those trials that had matching publications, yielding a total of 110 trials.
Hartung’s team found that 33 of the trials reported a greater number of serious adverse events on ClinicalTrials.gov than in the medical literature. For example, a 13,608-person study comparing the blood-thinning drugs Effient (prasugrel) and Plavix (clopidogrel) reported in the online database a total of 3,406 serious adverse events among all participants in the trial, and 3,082 in a related publication. (The patients in the trial were at high risk of heart attack, and were undergoing angioplasty, so it’s important to note that these adverse events were not necessarily linked to the drugs.)
Of the 84 trials that reported the occurrence of serious adverse events in the public database, 16 of the matching publications either failed to mention them or incorrectly reported that they did not occur. (Notably, 5 trials actually reported more serious adverse events in related medical papers than they did in the public database.)
Last week, we wrote about the results of a new survey on lab safety. One of the findings was that scientists are unlikely to tell others of health and safety infringements in the lab. Here Nathan Watson, founder of BioRAFT, a Digital Science-supported company which co-published the survey, tells his story.
My left index finger should probably glow green under 488nm light for the rest of my life. As a junior researcher, I was producing recombinant viruses to overexpress genes including Green Florescent Protein (GFP) and a number of oncogenes. While isolating the virus carrying GFP, I was supporting the test tube with my left hand and slowly pressing a syringe needle through the tube’s soft plastic wall. I pressed too hard and the needle went completely through the tube and into my left index finger. I washed the finger with iodine and soap, put on a new pair of gloves, and finished the virus isolation.
I told no one.
I checked the cells and my finger daily over the next two weeks, and to my relief, the cells glowed and my finger did not. I corrected my methods when working with the oncogenes and consider myself lucky I had my incident with just the GFP.
This is the reality of research. If you had asked me if safety was important to me, I would have said, “sure it is.” If you had asked me if my lab was safe and if my PI cared about safety, I would have said yes. Yet, did I get training on the specific experiments I was doing or the hazards I was working with? Not really. Safety training, beyond the general lab safety lecture during new employee orientation, often entailed a post doc giving you a detailed protocol and encouraging you to ask questions. Yet, as an enthusiastic researcher who believed he already knew his way around a lab, I (and others like me) was more concerned with the scientific objectives, not the rigid tedium of safe experimentation.
Continue reading Nathan’s story here.
Does this sound like a familiar tale? Let us know your own experiences in the comments section or on Twitter: @naturejobs
{credit}SOURCE: Center for Laboratory Safety, UCLA/NPG/Bonamy Finch{/credit}
The survey of around 2,400 scientists was commissioned by the University of California in Los Angeles (UCLA) Center for Laboratory Safety, in collaboration with Nature Publishing Group and BioRAFT – a company providing software for safety compliance, which receives funding from Digital Science, a sister company to Nature Publishing Group. The survey was in part commissioned in response to the death of research assistant Sheharbano Sangji following a lab fire at UCLA in 2009, and a first analysis of the results was published in the news section of Nature this week. Continue reading