The US Food and Drug Administration (FDA) has taken a harsher stance on its approval guidelines for new drugs so, despite a huge proliferation of multi-drug resistant strains of bacteria, the number of approvals for new antibiotics has dropped.
This harsh attitude towards approval is partly in response to the scandal surrounding Ketek (telithromycin), the antibiotic passed by the FDA in 2004 that was later linked to liver failure. The new rules now require applicant companies to show that patients are no more likely to die – of any cause – within 28 days of treatment with the new drug.
These new regulations are likely to cause much damage to pharmaceutical companies. London-based company AstraZeneca recently announced that its revenues have dropped by 15% (although this was partly due to a recent failure in late-stage clinical trials on drugs that were expected to restock the company’s store of products under patent). As the pool of money in the pharmaceutical industry diminishes, the same is happening in academia. The situation has led to AstraZeneca’s neuroscience research group combining knowledge with academics to take new drugs forwards.
In fact, pharmaceutical companies might be getting better at working with academia in general. GlaxoSmithKline (GSK) are attracting praise from scientists for announcing that they will make their raw data on clinical trials available to researchers, which is a rare move in clinical science, although other sciences such as genomics and particle physics are already familiar with sharing their data.
This transparency will hopefully help health professionals and researchers avoid making important decisions on patient health with incomplete information. It could also help speed up drug development and increase trust in industry-led research, which has been lacking in recent years due to ongoing scandals that have seen many major pharmaceutical giants fined billions of dollars.
But perhaps this transparency and openness won’t be so clear after all. GSK have said that an expert panel will be established to handle access requests to their clinical trial data to prevent people who don’t have a solid scientific question trawling through it. Many are against these restrictions, fearing that decisions about releasing the data would favour the big pharmaceutical giants rather than serving the public interest.
GSK say there is a risk that the data in the wrong hands could cause a public scare but Peter Groztsche, director of the Nordic Cochrane Centre, says that the more people who can look over the data, the less of a risk it becomes. The European Medicines Agency (EMA) believes public interest to be far more valuable than commercial interest, and is therefore making all the clinical trial data sets submitted to it publically available as of this year. In contrast, the US FDA still holds the data to be commercially confidential.
Although not everyone is completely happy about the way GSK have decided to release their raw data, this is still a step towards the pharmaceutical industry gaining greater public trust. It is hoped that other companies will follow GSK’s lead towards disclosure.
The data is not the only important factor that needs to be revealed. Following a recent review by the Cochrane Collaboration it is clear that the source of funding for research should also be exposed. In general, biomedical research funding comes from three sources: government agencies, private non-profit organisations and private industry. But funnily enough, in 2007 it was found that studies sponsored by the pharmaceutical industry tended to find positive outcomes for the drugs being produced by big pharma more often than studies on the same drugs sponsored by other sources.
More recently, the December 2012 Cochrane review provided a synthesis of 48 papers that compared industry-sponsored research studies to studies sponsored by other sources and, just as before, found that industry-sponsored studies reported greater benefits and fewer harmful side effects than those not sponsored by industry.
These findings call on the need for greater transparency on all levels; from the publication of full clinical trial data, to the unreserved disclosure of sponsorship. If the pharmaceutical industry is to gain the benefits of collaborating with academic scientists, and if it wants to regain the trust of the public, it needs to follow current trends and open up clinical trial data to the whole public. Their excuse that it would cause more public scares grossly underestimates the public’s rationality and, moreover, implies they have a worrying lack of confidence in the safety and efficacy of their products.
IMAGE: Sarar G, flickr