How does the GlaxoSmithKline scandal affect future clinical trials?


  • Author: Carlos Alberto Gómez Grajales
  • Date: 09 August 2013
  • Copyright: Image appears courtesy of iStockPhoto

As research becomes more and more expensive, it is not surprising that organizations aim to optimize the resources invested in research activities. The British pharmaceutical company GlaxoSmithKleine did this a few years back, locating a major research centre in China, in an effort to reduce expenses and, at the same time, ensure a quicker transition of their products into the Asian market. The move seemed to pay-off, as the facility quickly grew, reaching more than 400 employees around 2011 and becoming Glaxo's biggest research centre. This Shanghai office has not only become an example of a recent tendency of moving research efforts to emerging countries (more than half of the world's biggest pharmaceuticals are researching in China) but it has recently been under the spotlight due to an internal audit that was discovered a few days back. This audit concluded that, when investing in research, that cheaper is not necessarily the better and the document revealed that Glaxo's research centre has been surrounded by some dubious and unprofessional work, that has produced several flaws in its research, including the use of inappropriate protocols and some ethical misbehaviours.

thumbnail image: How does the GlaxoSmithKline scandal affect future clinical trials?

The internal audit was performed by Glaxo itself at the end of 2011 and just recently saw the light of day, thanks to the US media. Although some of the red lights in the document were linked to some unethical or inappropriate conduct, some of the flaws can be regarded as innocent mistakes, albeit critical ones. For instance, one of the issues included not appropriately following and recording some basic participants' behaviours, which, as any statistician may be well aware, may produce inaccurate results in certain situations. Glaxo's audit showed that, many times, participants weren't checked to verify they took the appropriate doses of the tested medicine. Besides being a risk to the participants (they could end up taking too much), this endangers the desired homogeneity within the design, since some patients may be taking a higher dose, thus presenting higher incidence of side effects. The opposite situation is entirely viable too, people not taking enough dose might not show a positive evolution due to an inadequate dosage (this could also mask some negative side effects as well). More critically, the audit found that, even when the researchers learned that the patients weren't taken the right doses, no follow up, nor register was devised to ensure that participants corrected this, or at least it was considered in the statistical analysis. These individuals should be treated as outliers, since their exposure to the medication would be different to that of the rest of the participants, yet due to the inappropriate recordings, it would be impossible to identify them in the analysis.

Other flaw found in the protocols, that was also described in the audit, involved researchers not reporting the results of a drug test performed in animals, even when that particular drug was already being tested in humans. This issue was described as a"mortal sin" by specialists in research ethics as it could endanger the participants in human trials. Thankfully, apparently no harm occurred this time.

Another scandal that related with the company's research efforts in China started even earlier in the year. In June GlaxoSmitheKleine fired the head of research and development in China after discovering that an article he helped write in the journal Nature Medicine contained misrepresented data. There are other accusations of bride and possible corruption regarding the payments that the Research centre did to several hospitals, by concepts of recruiting and following research participants (something we already know wasn't done properly). All this paints a sad landscape within Glaxo's research, an image that the company has been undoing during this year.

Glaxo said it has already invested in improving the quality controls and procedures involved in its research protocols in China, as well as tightened the payment procedures for clinical research coordinators. In all, company officials said that appropriate steps were taken to address the issues outlined in the audit. And in 2011, auditors noted that leaders at the facilities are interested in improving its methods.

This may be an isolated case, but it is an important lighthouse to guide other research centres and componies that are interested in working overseas. Adequate research does not only require equipment, but also an appropriate, ethic and competent staff, as well as strict quality control. And yes, it would be nice to have some professional statisticians to tell when the clinical trials are going awry.

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