ajor western pharmaceutical companies, including Pfizer, Astra Zeneca and GlaxoSmithKline, all of whom are conducting controversial clinical drug trials in India, are facing charges in the United States for bribing officials abroad to get favourable treatments in business.
In a written statement to The Sunday Guardian, Pfizer confirmed that it "has reached agreements-in-principle with the U.S. Department of Justice (DOJ) and U.S. Securities and Exchange Commission (SEC) staff to resolve matters concerning potentially improper payments made by Pfizer and Wyeth subsidiaries in connection with certain sales activities outside the United States. It would be premature to disclose terms at this time as we anticipate entering into and announcing final agreements in the fourth quarter of 2011."
A spokesperson from Glaxo Smith Kline confirmed: "The US Securities and Exchange Commission (SEC) and the US Department of Justice (DOJ) are conducting an industry-wide investigation into whether pharmaceutical companies may have engaged in violations of the Foreign Corrupt Practices Act relating to the sale of pharmaceuticals, including in Argentina, Brazil, Canada, China, Germany, Italy, Poland, Russia and Saudi Arabia. The Group is one of the companies that have been asked to respond to this inquiry and is cooperating with the SEC and DOJ."
Sources in Astra Zeneca India, said that the company was being probed by US government agencies for a case of bribery that took place in Serbia. They denied that there were links between clinical trials in India and the case being probed in the US.
Pfizer and its subsidiary, Wyeth, have paid fines worth Rs 675,000 earlier this year for four deaths caused during its clinical trials in the country, according to data provided by the Ministry of Health and Family Welfare.
Regarding its clinical trials, Pfizer maintained that "patient safety is a top priority at Pfizer. All Pfizer-sponsored clinical studies, in every country, follow accepted ethical, scientific and medical standards that protect the rights of participants. These include policies on informed consent, independent review, and post-study care. Pfizer studies are conducted in accordance with local laws and regulations and international standards."
Nine companies including Pfizer, Bayer, Sanofi and Eli Lilly have paid compensation to 22 people in India for deaths occurring because of the clinical trials they conducted in 2010.
They were directed in April 2011 by the Drug Controller General (India) to pay compensation to the dependants of the deceased. The total compensation paid in the 22 cases amounts to about Rs 50 lakh. A clinical research organisation, PPD Ltd, paid the maximum compensation involving death in one case during the trial of a drug called XL-184/Placebo.
Meanwhile, the Indian Medical Association has taken strong exception to western pharmaceutical companies conducting clinical trials in the country. While accepting that new medicines are required to treat diseases, D.R. Rai, secretary general of the IMA, said, "Strict guidelines must be observed in such matters. Western pharmaceutical companies should not treat the Indian population as guinea pigs."
According to a Ministry of Health statement, "The Serious Adverse Events (SAEs) of deaths related to clinical trials in 2010 were initially reported as 25 in which nine companies were involved. Subsequently, it was revealed that in two cases the deaths were reported two times for the same patients. Further, in one case, the ethics committee and the investigator later on clarified that the death was not related to clinical trial. Thus, there were 22 SAEs of deaths attributable to clinical trial in 2010."