"These institutions and associated healthcare professionals contribute their knowledge, time and expertise to partner with the pharmaceutical industry to discover and develop new medicines and vaccines to treat and prevent diseases," said Moncef Slaoui, GSK’s Chairman of Research and Development. "We understand the changing expectations for our industry in regards to these partnerships and so we are choosing to take steps to provide increased transparency to details about the way we work together. We continue to believe that w orking together to examine the benefits and risks of potential medicines is critical if we are to maintain our contribution to improving global health."
The report on payments for research (us.gsk.com) lists 127 studies involving 595 different lead researchers or principal investigators (PIs) in the U.S. who were associated with those studies. The list also includes the clinical research study number (which links to details about the research disclosed on the GSK Clinical Study Register, the city and state of the lead researcher or PI and the amount of money the institution received during the year for a particular study.
In total, GSK paid $28.5 million to these institutions during 2010 for their help in conducting research on topics including cardiovascular disease, chronic obstructive pulmonary disease (COPD), macular degeneration, renal and other cancers. The payments include the costs for study visits and any other costs to conduct the research such as: procedures (diagnostic tests, laboratory services and patient assessments), detailed monitoring of clinical outcomes and drug safety, and institutional overhead, etc. In most cases, GSK has no knowledge as to the amount of money paid to the individual PI or lead researcher.
This is a small part of the significant investment made by GSK in research and development each year. In 2010, the company invested $6.9 billion for R&D globally. GSK has progressed 10 new compounds and vaccines into Phase III clinical trials since the start of 2010. The company has a peer-leading pipeline of about 30 late-stage assets.
Beginning in January 2009, GSK implemented a series of initiatives in the U.S. to increase transparency about its research to the public, including:
- Posting all observational studies, meta-analyses and studies of terminated compounds on the GSK Clinical Study Register - GSK began posting a broader range of study results on the GSK Register. GSK already posted on the register the results of all Phase l-lV clinical trials of marketed medicines and the results of certain observational studies and studies of terminated compounds.
- Committing to publish all clinical research results in the scientific literature - GSKpublishes all clinical research of its medicines either as manuscripts in peer-reviewed journals or, when studies are not accepted for publishing, provides context and interpretation via the GSK Clinical Study Register to supplement the result summary which is posted.
- Reporting clinical trial principal investigator names and institutions - The names of the principal investigators participating in GSK-sponsored clinical trials, together with the institutions they are working in, are included in the protocol summary for new studies posted to the GSK Clinical Study Register.
- Providing quarterly updates to its report listing grants and sponsorships to U.S.-based health-related organizations. This report includes grants to organizations such as hospitals, teaching institutions, managed care organizations, professional associations, patient advocacy groups, and continuing medical education companies located in the U.S. and Puerto Rico.
GSK also provides an update on payments to U.S. healthcare professionals
GSK also posted an update to its quarterly listing of healthcare professionals who have been paid for speaking on behalf of the company or advising GSK. The update showed that in 2010, there were 5,331 healthcare professionals in the U.S. paid a total of $56.8 million for such activities. The company has voluntarily posted these payments since 2009.
"GSK believes properly engaging doctors to share their knowledge with other physicians in peer-to-peer education programs helps them keep up with advances in medicine," said Deirdre Connelly, President of North America Pharmaceuticals for GSK. "Society expects our business to be conducted openly and transparently and in a way that does not create even a perception of inappropriate influence," she said. "Our industry has made significant changes in how we operate and at GSK we continually re-examine how we conduct our business to ensure that our values are reflected in all our practices."
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.