RTI and clinical trials

Sarah Hiddleton has a useful note today in the Hindu about the Right to Information and Clinical trials in which she discusses how disclosure of test data is in the public interest. This is against the backdrop of the Mahyco/Greenpeace fight over Bt Brinjal test data currently being fought in the Delhi High Court. Some useful international comparisons in the article which make it a compelling read.

The question therefore is this: when does public interest in trial data outweigh commercial interest?

If the researchers had not gone to such lengths to obtain full data from the U.S. Food and Drug Administration (FDA) under the freedom of information act, we would never have known that published data available to the scientific community had not included significant information from unfavourable trials (nine of these were refused by the FDA, data from four of them were obtained from a company website). We would have also been ignorant of the fact that the FDA had not spotted data manipulations from which conclusions were drawn and approved the drug on that basis. Nor would we have known that the companies involved had breached the trust of those who underwent the trials, the doctors who prescribed the medicines, and the patients who took them. Nor that these companies have made massive profits for something that has not stood up in the trials.

What if a product was found not just to be ineffective, but harmful? Just 10 days after Kirsch’s results were published, GlaxoSmithKline was found to have withheld clinical trial data from the United Kingdom regulator, the Medicines and Healthcare Regulatory Authority (MHRA), that showed that its anti depressant increased the risk of suicide among teenagers, and that it had known this since 1998.

Does putting such data in the public domain affect a company’s commercial interest: Yes. But does the public interest outweigh this? Yes, because if the product is useless or harmful, there should be no commerce in it in the first place.

Companies claiming that this might affect their intellectual property would do well to remember that this is at the core of the a defined set of criteria through which society gives up its fundamental immediate right to health to grant a right to property. A patent, which gives a company a monopoly in recognition of the risks it undertakes in product development, is awarded if a product is new, involves an inventive step, and has an industrial application - in other words if it is useful.

A very long time ago, I wrote this article on Data Protection that has since been quoted somewhat widely. Has some useful information on clinical trials, although my position is opposite to what is stated in the article.

Monsanto Vs. Greenpeace in the Delhi High Court

Some news today about Mahyco’s (Monsanto’s Indian partner) suit in the Delhi High Court challenging the Central Information Commission’s November 2007 order which required the Department of Biotechnology to disclose information pertaining to Bt Brinjal.

The Maharashtra State Information Commission had previously denied this request on the ground that it “would affect the competitive position of a third party” (Sec. 8 ) - in this case Monsanto. The CIC had overruled this decision holding that notwithstanding the existence of such a ground of withholding of information, where public interest lay in the disclosure of information, such information could not be denied. The Delhi High Court passed an interim order in December 2007 staying the order till the next hearing of the case on April 23.

More details in this Business Standard article.

Greenpeace has obtained similar data on Monsanto’s genetically modified insect resistant maize in Europe through a court order. The Monsanto data, when independently evaluated, had given rise to conclusions that were contradictory to Monsanto’s observations.

Armed with the new data, the international NGO had launched a campaign, though not with much success, to see that the marketing approval given to the particular maize variety (MON 863) in Europe was withdrawn. Greenpeace is looking at the possibilities of a similar review of the data generated by Mahyco for its brinjal variety..

What’s startling about this suit is that Mahyco’s argument that in disclosing this information, India is violating our TRIPs data protection obligations. This is the Novartis case all over again. The Delhi High Court is notoriously more narrow-minded with patent suits and I hope this isn’t a strategy to arrive at data protection by other means.