Following the steps of the vast majority of large pharmaceutical companies, GlaxoSmithKline (GSK) recently published a list of payments made during 2010 for clinical research studies led by U.S. healthcare professionals.
In announcing the publication of these payments, GSK noted that “clinical trials are an important step in the lengthy process of discovering and developing new medicines” and that “GSK works with these independent institutions and healthcare professionals because they have considerable expertise in conducting research that contributes to the body of knowledge about diseases and potential new treatments.”
Moncef Slaoui, GSK's Chairman of Research and Development asserted that, “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.” She also recognized that, “working 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 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, 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.
Beginning in January 2009, GSK implemented a series of initiatives in the U.S. to increase transparency about its research to the public.
First, GSK posts all observational studies, meta-analyses and studies of terminated compounds on the GSK Clinical Study Register. GSK also 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.
Second, GSK publishes 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.
Third, GSK reports 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.
Fourth, GSK provides 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.
Last but not least, GSK provides a quarterly update on payments to U.S. 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.
Deirdre Connelly, President of North America Pharmaceuticals for GSK, asserted that, “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.” GSK has also recently implemented changes in the way it conducts its U.S. commercial business to be more open and transparent.
For example, GSK strengthened guidelines that cover U.S. healthcare professionals who speak and consult with the company. Since 2010, GSK has:
- Expanded background checks and qualification criteria for potential speakers to exclude anyone with a state or federal sanction or discipline.
- Lowered the limit on payments to healthcare professionals in the U.S. for speaking and advising. Fees are now restricted to a maximum of $100,000 a year for an individual, down from $150,000 in 2009.
- Changed its policy to prohibit speakers from using their own slides in programs they conduct for GSK. This change was made to ensure that all the available information on medicines – both benefits and risks – is presented in a fair and balanced way, and in accordance with the FDA approved product label.
Additionally, GSK has strengthened internal controls to distinguish the exchange of scientific information from promotional activities. GSK has expanded internal guidelines that govern the interaction and exchange of information between GSK and external communities to advance scientific and medical understanding, including the appropriate development and use of our medicines and vaccines, the management of disease, and improved patient care.
This is clearly distinct from commercial promotion, which educates customers on the prescription, supply, sale or use of medicines and vaccines. These principles ensure a clear, visible distinction between commercial interests and GSK’s scientific activities such as advisory boards, publications, scientific congress activities, medical education, and other engagement with key stakeholders.
GSK also implemented a unique continuing medical education (CME) program on Jan. 1, 2010, which limits CME grant applications to approximately 20 academic medical centers and national-level professional medical associations. All CME providers must be directly accredited by a recognized accrediting body, and GSK now funds only CME by not-for-profit providers. The first grants were awarded mid-year to programs designed to close evidence-based gaps in patient healthcare, and to support the optimal performance of healthcare professionals.
In addition, GSK is shifting pay incentives in the sales organization from a focus on prescription volumes to providing information and support that healthcare professionals want and need. GSK is putting in place a new and unique incentive compensation system in which individual sales representatives do not receive bonus pay based on the prescriptions they generate but on their scientific and business knowledge, feedback from customers, and overall performance of the business unit they support.
Ultimately, GSK’s commitment to transparency should reassure many patients, Americans and consumers of the company’s focus on ensuring integrity in the practice of medicine, education and training.