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European Pharmaceutical Contractor

Breaking News

Two items in the newspaper on 26 July caught my attention. The first article’s headline read “Cancer experts unite against EU data law”, and discussed the proposed EU General Data Protection Regulation which would – according to the report – require doctors across Europe to obtain explicit and specific patient consent every time they wished to use their data. Seemingly, this means that any patient could give consent to personal data usage in one trial, but if this data were to be used in further studies, specific permission would have to be provided again.

At present, patients can give permission in perpetuity so that comparison studies using the same data can be carried out. However, the planned new restriction will prevent such studies, especially Cochrane trials, from being conducted unless consent is given by every patient – alive or deceased.

Although the proposed regulation makes no specific mention of cancer studies, the follow-up of patients would – argues the European Society of Medical Oncology – prove very difficult, if not impossible, and would put a halt to many public health research efforts. The draft regulation has been available for over two years and, clearly, the efforts of cancer researchers have been inadequate to persuade the European Parliament that the planned legislation is misguided. Nevertheless, the regulation was approved by the Parliament by a huge majority, and it may prove too late to change this outcome in the near future (also see page 28).

The second item, entitled “Google sets its sights on early detection of deadly diseases”, reported that Google is to collect samples of human tissue from thousands of people to potentially detect the earliest signs of cancer and other fatal diseases. The study will also take blood, urine, saliva and DNA samples from test subjects in order to determine what comprises a healthy human being; the objective being to detect a biomarker that will predict the onset of diseases.

Google’s mission statement is to “organise the world’s information and make it universally acceptable and useful”. If the EU General Data Protection Regulation is not amended, then this objective will surely be seriously compromised and not applicable to the EU. Google has already shown the power of its algorithms in detecting changes in human behaviour through its study of the transmission of avian flu in the US. Here, the company was able to predict outbreaks two or three weeks prior to the estimations made by the Centers for Disease Control and Prevention, by analysing search patterns on the Google search engine. Restriction on its activities in the public health area may have a significant impact in Europe.

As I looked through my particular newspaper over the entire week, I also noticed a discouraging pattern. The business section summarising the main events of the previous day had no mention of any noteworthy healthcare-related topics.

Given the interest of the general public in their health, this seemed to be a surprising omission. The one reference that was made during the week, was the announcement of the submission for the malaria vaccine registration from GlaxoSmithKline. The company – currently under considerable financial pressure due to falling sales and scandals in China – is receiving little credit for its altruistic development of this vaccine.

This tends to confirm my view that the pharmaceutical industry is currently a media scapegoat, whatever its achievements. For example, the BBC recently reported on an ongoing prostate cancer study that was being carried out with thousands of patients worldwide, and seemed to imply that this was being financed by Cancer Research UK, rather than a pharma company. Perhaps the industry feels that, at the present time, a low profile is for the best.

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