An influx of safety concerns

In terms of clinical trials there is one thing likely to set alarm bells ringing in the minds of any pharmaceutical executive: "safety concerns". Interestingly - and perhaps worryingly - safety issues have been punctuating the pharmaceutical marketplace by a significant degree over the past week or so - calling into question the very basis of drug discovery.

We start in the UK, where the tragic death of 14-year old schoolgirl Natalie Morton on Monday sparked considerable concern over the safety of GlaxoSmithKline's HPV vaccination, Cervarix.

The drug, which protects against the two strains of the human papilloma virus (HPV) that cause more than 70 percent of cervical cancer cases, has been used as part of the UK's routine program for vaccinating 12 and 13-year-old girls since September 2008.

The current "catch-up campaign" for older girls - which Natalie had taken part in just hours before collapsing - is now underway.

Following the girl's death, while the batch of the vaccine was put in quarantine while post mortems were carried out, reports from the UK's Medicines and Healthcare Regulatory Agency surfaced that they had received 2137 reports between 14 April 2008 and 23 September this year regarding reactions to the vaccine.

Meanwhile GSK defending Cervarix, saying that about a million girls in the UK had already safely received the jab.

Then, despite reports from the local NHS authority saying the UK's ongoing vaccination program would continue after a short pause, and the discovery that the girl actually died from a large and previously undetected tumour in her chest and not from side effects of the jab, GSK were dealt another blow with news of the US Food and Drug Administration's (FDA) decision to delay their approval of the vaccine.

While the FDA went on to insist there was no reason to assume the delay had anything to do with UK schoolgirl's death - nor that there were any underlying safety issues causing the FDA concern - their decision couldn't have come at a worse time: at least in terms of the ensuing safety debate.

As such, as reported on the company's website on 25 September, Swiss drug developer Roche also joined the "safety concerns" debacle when six cases of patients with heart failure symptoms prompted a halt to enrollment in a National Cancer Institute sponsored study of its blockbuster drug Avastin.

According to reports, US National Cancer Institute and US Eastern Cooperative Oncology Group (ECOG), who are conducting the study, told Roche it had suspended adding new patients to the late-stage study because of heart failure symptoms in the early-stage breast cancer patients.

As author of the Pharma Strategy Blog, Sally Church notes: "Any time you see the words 'study halted over safety concerns' you know the news isn't going to be cheering."

And, in reference to the Roche case, she adds: "While six patients out of 3439 isn't a lot (less than 0.2 percent), it will be interesting to see whether this is an expected anthracycline problem or an increased potentiated by two drugs that impact the vascular system."

And Church certainly has a point: the recent wave of safety-questioning issues and setbacks - at the time of the FDA delay on Cervarix, for instance, the agency made a point of stressing they had recently put back several action dates as a result of its growing workload - are likely to raise significant issues for pharmaceuticals in the coming months.

Not least as vaccinations against the pandemic influenza A (H1N1) come to market, once again calling into question the validity and usability of new vaccines.

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