Current Events Pharmaceuticals

Trials and transparency

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a scathing report criticizing the medical procedures Parexel used in testing the TGN1412 drug. In-Pharma (“Parexcel back in hot water…“) reports that six individuals suffered severe side effects such as organ failure swelling of body parts due to poor administration of the trials by Waltham, Mass.-based Parexel. In the US, Merck has received much negative press for withholding data from its trials of the Vioxx painkiller. After 11 children given Paxil attempted suicide compared to only one attempt with a placebo, GlaxoSmithKline had to re-label the drug to warm of an increased risk in child suicide rates (WebMD’s report).

Amid all of this negative press regarding pharmaceutical clinical trials, one organization may have a solution. The May 20th-26th Economist (“Trials and transparency“) reports that the World Health Organization (WHO) recently released its suggestion for universal rules of disclosure for pharmaceutical clinical trials. The article states:

“At the moment, the industry can choose from various voluntary initiatives encouraging disclosure and dozens of registries, but it is governed by few hard-and-fast rules.

With its new manifesto, the WHO hopes to change all that. It outlines 20 data requirements that must be disclosed for all trials. Provocatively, it insists that all such information must be disclosed before the first patient is registered for a trial—even for early-stage trials.”

One of the major complaints of researchers is that medical and academic journals only publish the results of successful trials even though much could be learned from the results of unsuccessful experiments. PHARMA claims that compelling drug companies to disclose early experiment results may reduce innovation for fear that competitors may steal their ideas. The Economist argues the following:

“The fears are overblown. Full disclosure early in trials might indeed make it harder for firms to protect clever new ideas. But pharmaceutical companies should still enjoy patent protection. In any case, they already routinely look for clues as to what their rivals are doing. The WHO argues that transparency could even improve the efficiency of the drug discovery process. The same firm that loses its lead on one drug might catch up or beat rivals on three others using information gained from a newly transparent process.”

The Healthcare Economist would argue that it is rare that more information harms society.  “The more information, the better.”  The WHO rules are sensible and would lead to more disinterested evaluation of pharmaceuticals in development; I agree with the Economist that innovation would not be significantly reduced.