Monday, April 25, 2016
The World Health Organization has alleged "fraud" and pointed to violations of good laboratory and clinical practices at Semler Research, a Bengaluru-based contract researcher that was pulled up last week by USFDA on data integrity issues.
"Manipulation of at least five studies over an extended period of time indicates this is a common practice," the world health body wrote in its 'notice of concern' report on April 12 on the clinical research outfit.
WHO said upon investigations of study documentations for products like atazanavir, acetazolamide, celecoxib and saquinavir, inspectors identified evidence of such manipulations by comparing concentration time curves for specific pairs of study subjects. "It is of the impression that to execute this type of manipulation, several staff members on various levels within the organization have to be collaborating and coordinating. The issue is thus not confined to a single person operating outside of the quality management system."
The WHO team cited its inspections between January 27 and 31, 2015, and a follow-up between December 2 and 5, 2015, and highlighted issues such as manipulation of study samples. The WHO said its findings bring into question the validity of studies (performed for 12 products) that are under assessment, but not prequalified.
Those products include fixed dose combinations of HIV product efavirenz, lamivudine and tenofovir, another combination of lamivudine, zidovudine and nevrapine, antibiotic drug azithromycin, antimalarial combination of artemether and lumefantrine, anti-TB drug combination rifampicin, isoniazid and pyrazinamide. It also brought into question nearly a dozen other products that are already prequalified and belong to companies such as Mylan, Micro Labs, Lupin and Strides.
In its letter, the WHO noted Semler had acknowledged that "4 FDA studies and 1WHO study have questionable data", that these trends "cannot be physiologically explained" and that there were "system gaps identified during the retrospective investigative audit in the system due to which we are not able to identify who and why this happened".
"This implies that Semler acknowledges existence of these unnatural trends in their data, the root cause has not been identified and the system cannot support adequate root cause analysis for these issues of concern," WHO said.
For products that pre-qualified, the WHO has directed applicants that the risk assessments with proposed corrective and preventive action be submitted for all the studies within 30 days and for those that are not prequalified, it has requested for bio-waivers where applicable, and submissions of fresh studies which may be extended to 12 months.
Source : economictimes.indiatimes.com
