Corporate crimes in pharmaceutical industry are a growing menace threatening the lives of millions of innocent and less informed people all over the world. When such crimes are committed by powerful MNCs with the connivance of a section of medical practitioners, the scope to fight or defend such aggression is limited for the common man. And if such offences can be committed so blatantly in the US, one can imagine what these drug MNCs can dare to do in developing countries. Only last month, Pfizer Inc was dragged to court in the US for off label promotion of its drug, Neurontin. The world's largest pharmaceutical company agreed to plead guilty and pay a compensation of 430 million dollars in fines and settle charges. Now, GSK, the second largest pharmaceutical corporation in the world is in the dock for another serious offence. New York Attorney General, Eliot Spitzer, last week sued GSK for consumer fraud charging the company with concealing negative information about Paxil, its popular antidepressant drug. The lawsuit says that the British drug giant sponsored five clinical studies on the use of Paxil in children but only published the results of the most favourable one. Although the data showed drug might be linked with the increased risk of suicidal thoughts or acts, the company failed to disclose the possible link or the negative trial results in the medical information letters sent to the physicians. The lawsuit says that about 2.1 million prescriptions were written for paroxetine, the chemical name of the drug used in Paxil, for children and adolescents in the US in 2002.Nearly 90,000 of these prescriptions were for youth with mood disorder. And the mood disorder prescriptions accounted for about 55 million US dollars for GSK in 2002.
It is to be recalled in this context that the UK regulatory authorities last year had asked the drug companies marketing antidepressants to provide the unpublished data of trials of these products. And this data revealed that several anti depressants including Paxil might trigger suicidal thoughts in some young users, a problem not disclosed in any of the published studies. In the US, a company seeking to get a new drug approval must submit the results of all clinical trials it conducts. But the US FDA holds that information in confidence until the drug is approved for sale. Only summaries of those trials and not the complete data are publicly released. GSK, in this case, has defended itself by saying that it provided all the results of Paxil trials to the US FDA. Whether this defence is true or otherwise the clinical trial data of the drug in its entirety did not reach the medical practitioners. The regulatory authorities have the responsibility to protect the public by ensuring that the drugs that come to the market are safe and effective. Paroxetine is being marketed in India by Ranbaxy, Cipla, IPCA and Intas and DCGI has decided to examine the safety profile of the drugs. It is significant in this regard to consider a demand by a growing number of medical experts to create a public registry of clinical trials with a uniform pattern of disclosing results of all studies conducted by drug companies. Such a registry will enable the policy makers and medical practitioners to easily learn about all trial results before deciding to grant marketing permission.