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IMPROVING TRANSPARENCY IN THE PHARMACEUTICAL INDUSTRY
05 Mar 2010
Clinical Research
The issues of transparency and trust seem to have emerged within the pharmaceutical industry of late.
Over the past few months, a campaign called Pharmageddon 2012 has been running across a dedicated microsite, Twitter, YouTube, Facebook, a blog and direct mail in the US.
At the beginning of December, S+R Medical Communications and its sister agency Friday Morning revealed that they were the brains behind the campaign, designed to raise awareness about the "eroding trust between physicians and pharmaceutical companies that has mostly been a result of aggressive marketing efforts".
The agencies' aim was to bring to light the complaints that doctors and physicians have about the pharmaceutical industry.
Pharmageddon 2012 sparked a debate within the pharmaceutical industry on the issue of trust and transparency, which led to an editorial on the topic in the November issue of Med Ad News.
It is not only the issues of sales reps and their tactics that has emerged in terms of transparency, but also pharmaceutical companies conducting clinical trials on their own drugs.
In November, the British Medical Journal (BMJ) published articles on whether it is acceptable firms to do so, with two writers presenting different sides of the argument.
Dr Ben Goldacre and Professor Vincent Lawton presented their cases from opposing viewpoints. Dr Goldacre argued that since the practice of medicine is based on evidence which needs to be of the highest quality and pharmaceutical companies have a conflict of interest.
"They want to sell their products, and so naturally they want a positive result from the trials they sponsor," he contended.
Dr Goldacre cited research, also published in the BMJ, which showed that studies sponsored by drug companies were four times as likely to have outcomes which favoured the financer, compared to trials which had other sponsors.
He said that a common problem was that pharmaceutical companies were able to choose which data to publish and which to make unavailable.
"It is inevitable that publishing positive results more than once will cause doctors to think a drug is better than it really is, since doctors are busy, and cannot each conduct forensic checks on every trial they read," he claimed.
But Professor Lawton, a healthcare consultant and non-executive director, countered: "The industry develops medicines through years of painstaking research by some of the best scientists in the world, often in collaboration with academic researchers."
He said that proposals to bring in an objective third party to control the system should be critically examined.
Professor Lawton insisted that trial designs and protocols - something called into question by Dr Goldacre - were endorsed by regulators "who assiduously guard against inadequate trial design, insist on good clinical practice standards and ensure high quality analyses".
In the UK, ethics committees are fully independent and usually established by the NHS, while the regulatory bodies the US Food and Drug Administration and the Europe Medicines Agency do not allow trials to begin without their approval.
"The drug industry actively worked to change the public's negative perception of clinical research and their lack of trust in science," he insisted.
"In January 2005, the major drug industry trade associations from Europe, Japan, and the US announced their commitment to increase the transparency of clinical trials sponsored by their member companies," Professor Lawton continued.
He added that this pledge included the industry registering its trials in central, publicly accessible databases, so that information is available, be it good or bad. Most pharmaceutical companies also usually publish clinical trial results, whether positive or negative, on their own websites.
In the interests of transparency, GlaxoSmithKline (GSK) recently published a list of the fees paid to US healthcare professionals between April and June for speaking and consultancy services. GSK also committed to update this list quarterly.
It is one of a number of measures that the company has undertaken to improve openness and honesty to boost trust with consumers and other stakeholders.
These include publishing all clinical research results in scientific literature and reporting clinical trial investigator names participating in GSK-sponsored trials and institutions they are working in, both of which took effect in January 2009.
