22 November 2017

How much you can rely on Clinical Trial data?


How much you can rely on Clinical Trial data

In 2012, pharma companies had been critically accused for burying bad data from clinical trials for years before their post-approvals to the market despite of many mergers and acquisitions in the industry.

Roche, an integrated healthcare services India, were hesitant to release all the trial data for oseltamivir a kind of Tamiflu. The company had promised to release the complete data set back in November 2012 but still they haven’t done it as given by British medical journal (BMJ).The company is also been slammed by the EMA i.e. European medicine agency for failing to handle the adverse event reports correctly. In June 2012, MHRA i.e. Medicines and Healthcare products Regulatory Agency, the UK regulator, reported that up to 80,000 potential adverse events were not properly assessed. EMA has started a violation procedure against the company that could lead to a fine of up to 5% of its annual EU turnover which is CHF640 million (£430 million), based on 2011 figures.

In October 2012 GlaxoSmithKline, also announced that, they would make a detailed, anonymised, patient-level data on both marketed and failed drugs that are available to scientists, inspite of the stinging criticism in the past over burying trial data on rosiglitazone (Avandia).

The European Medicines Agency (EMA) has made a commitment to provide a widespread proactive publication of trial data post-approval. A trade body named EFPIA i.e. The European Federation of Pharmaceutical Industries and Associations has supported EMA, despite the decision made by EMA to release preclinical data that might be a greater use to generic competitors. According to Richard Bergstorm, EFPIA director general, the general public trusts regulatory agencies should be independent.

The European commission has also proposed a new regulation in clinical trials, to create a more competitive environment for medical research in Europe. Basically, it would simplify and standardise clinical trial administration. The commission has estimated that, from 2007 to 2011, the number of trials in Europe reduced by 25% mainly because of the complexity involved in conducting trials across different member states.

In 2012, AstraZeneca a global, innovation-driven, integrated biopharmaceutical company, announced it plans to cut a further 2200 R&D jobs because the neuroscience research team of 40–50 Astra scientists would carry out development work externally with academic and biotech partners.

In the same year, even the US biotech named Alnylam, reduced its workforce by three times to finance clinical development. Similarly, another US biotech, named Targacept, closed their entire labs to conserve capital after an ADHD trial failure.

Despite the past growth, spending on health in the EU has reduced for the first time since 1975. The pan-EU drop was 0.6% in 2010, as compared to an annual growth of 4.6% in the previous decade and this decline in spending will have a long-term effect on healthcare outcomes. The drop was seen mainly due to the economic crises in Greece which fell by almost 7% in 2010, as compared to the growth of almost 6% a year in 2000–09, according to a report given by the Organisation for Economic Co-operation and Development and the commission

Forecast says that spending on the latest medicines will rise to 1% annually for the next three years, in the mean while, to avoid large-volume medicines lose patent protection; the National Health Service (NHS) is estimated to save nearly £3 billion as reported by UK Office of Health Economics.

In 2012, due to the end of patents protecting several big selling drugs, the healthcare providers themselves must save the drugs. The sales of Sanofi’s blood thinning agent clopidogrel (Plavix) have decreased rapidly by 70% from $9.3 billion (£5.8 billion) in 2011, given by EvaluatePharma.

In 2013, the annual sales of non-patent drugs is expected to be $29 billion as compared with $67 billion in 2011 and might reach $40 billion in 2014 with more than two thirds of those sales likely to head the way of the generics companies, according to the research made by EvaluatePharma.

Some of the first-in-class drugs such as Dapagliflozin (Forxiga) from AstraZeneca and Bristol-Myers Squibb which is a diabetes medicine were given a positive feedback by EMA in 2012.

Spanish company named Almirall’s linaclotide (Constella) is a synthetic peptide that is the first drug designed to treat irritable bowel syndrome, UniQure’s alipogene tiparvovec (Glybera), and Europe’s first gene therapy medicine was approved in EU.

In US, manufacturing problems is still a concern in New England Compounding Centre in Framingham, US. Filthy conditions were found in the plant after nearly 500 patients across the US developed fungal meningitis, 36 of whom later died due to spinal steroid injections formulated there as per the analysis made by the Food and Drug Administration (FDA).

To deal with the manufacturing problems, EMA has given a plan, which includes improved information sharing and encouraging industry in improving its continuity planning.

As per the forecast, in the next few years, the decade to follow could bring a ‘golden era of renewed productivity and prosperity’ for the pharma industry given by PricewaterhouseCoopers (PWC), a UK consultancy.

Source: rsc.org

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