Life Science Compliance Update

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32 posts from March 2011

March 31, 2011

Physician Payment Sunshine: GSK Reports Research Payments

Sunshine_1 
 
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.

Physician Payment Sunshine: Pfizer Reports $177 million in Payments to Over 200,000 Health Care Professionals - Report Outlines Importance of Interaction to Health Care System

Sunshine 

Pfizer Inc. released a report detailing the company’s financial interactions with health care professionals and researchers in 2010.  The report shows just how important those interactions are for research and accurate use of therapies.  Specifically, the report presents 2010 data on payments -- including compensation for clinical research activities, professional consulting, and speaking at expert-led forums –- and the value of other items, such as meals, educational items and reimbursed travel expenses, provided to U.S. health care professionals who are licensed to prescribe medicines.

The report represents data collected from January through December 2010 about interactions with nearly 200,000 health care professionals.  Of approximately $177 million reported, the majority (61%) went to clinical trials and related research and development expenses. 

Dr. Steve Romano, vice president, Medicines Development Group for Pfizer, asserted that the company “depends on the medical and scientific community for a broad range of activities, from conducting clinical trials to providing insight about patient care needs.” 

He noted that through Pfizer’s interactions and collaboration with physicians, Pfizer “receives valuable information that can help them better serve doctors and patients, or share information that health care professionals may use to make better treatment decisions for their patients.” 

Upon releasing the payments, Mary Woolley, president of Research! America asserted that, Research partnerships with Pfizer and other biopharmaceutical companies help to drive innovation and lead to better, safer medicines and improved lives.” Ms. Woolley further noted that, “Pfizer's financial transparency in their relations with healthcare providers demonstrates the significant commitments they've made in supporting clinical research and discovery.”   

Clinical Research  

Approximately $108 million of the total payments disclosed reflects work conducted with nearly 1,000 research organizations and academic medical centers to study how medicines work and to develop new medicines.  Pfizer’s payments to these institutions supported critical clinical trial activities including patient recruitment, coordinating and conducting the trials, and complying with legal and regulatory requirements.  These payments represent a small portion of Pfizer’s total investment in research and development. 

Professional Advising 

Approximately 1,400 experienced health care professionals provided input and advice to Pfizer to ensure the company addresses the real needs of clinicians and patients.  These professionals were compensated an average of approximately $6,200 per person in 2010 in return for their time and expertise.  

Expert-Led Forums 

Approximately 4,600 experienced health care professionals were selected as speakers to educate their peers about health conditions and the safe and appropriate use of Pfizer medicines.  These professionals were compensated an average of approximately $7,400 per person in 2010 for their work.  Speakers and attendees were also often provided meals at these events. 

Dr. Owen Garrick, president-elect of the American Medical Association Foundation, asserted that, “The AMA Foundation supports Pfizer and other pharmaceutical/biotech companies in their commitment to transparency in their financial relationships with doctors.”  Dr. Garrick recognized that, “physicians learn about new discoveries, new innovations and improved products from many different sources and in many different ways.”  

As a result, he pointed out that, “these relationships and financial transactions enable vital research and the development of new and innovative medicines, and provide health care professionals with up-to-date and valuable information to help inform better treatment decisions for their patients.”         

Pfizer’s press release also noted that the company “is now reporting data for health care professionals who received payments, meals or educational items worth $10 or more. For health care professionals who received more than $100 in total value during 2010, all payments or items are reported regardless of value.”  

Pfizer’s “reporting complies with the company’s Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services and also reflects the minimums and thresholds set forth in the transparency reporting provisions of the Affordable Care Act (Section 6002). 

Ultimately, the broad scope of Pfizer’s current disclosures puts the company ahead of many others in making the types of disclosures that will soon be required of companies subject to this federal law.  Going forward, Pfizer said it will release its disclosures on a quarterly basis, adhering to the new dollar minimums and threshold for reporting.  The next report will be released in June 2011.

JAMA Disclosure of Interests in Meta Analyses

Metaanalysis 
A recent article from the Journal of the American Medical Association (JAMA) noted that, “disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships are sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals.” However, “authors of meta-analyses, are not required to report COIs disclosed in original reports of included RCTs.” 

Background 

Over the past several years, “conflicts of interest (COIs) related to the funding of biomedical research by pharmaceutical companies and financial relationships between researchers and pharmaceutical companies have come under increased scrutiny.”

According to the authors, “COIs may influence the framing of research questions, study design, data analysis, interpretation of findings, whether to publish results, and what results are reported. 

 

For example, the authors pointed to various studies, which showed that “results from positive trials and from favorable analyses are more likely to be published than results unfavorable to sponsors. In addition, they cited studies, which found that “compared with nonindustry-funded trials, pharmaceutical industry–funded studies more often yield results or conclusions in support of the sponsor's drug, and authors' relationships with drug manufacturers have been linked to favorable assessments of drug efficacy and safety.” 

To address this issue, the Consolidated Standards of Reporting Trials (CONSORT) guidelines require disclosure of study funding sources in trial reports. Moreover, the International Committee of Medical Journal Editors (ICMJE) guidelines recommend disclosure by authors of study funding sources and also of author-industry financial ties. However, as noted above, “there are no guidelines for the reporting in meta-analyses of COIs disclosed in included randomized controlled trials (RCTs).”

 

While the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement requires meta-analysis authors to report the funding source of a meta-analysis, it does not address the reporting of COI from included RCTs.”  

This concerned the authors because “meta-analyses are cited more than any other study design and prioritized in grading evidence for practice guidelines.”In addition, the authors noted that “without documentation in meta-analyses of COIs from included RCTs, users of meta-analyses may not have access to important information that could influence their evaluation of the risk of bias in the evidence reported.” As a result, the authors decided “to investigate whether meta-analyses of pharmacological treatments published in high-impact biomedical journals report COIs disclosed in included RCTs.”

The objective of the study was to investigate the extent to which pharmaceutical industry funding and author-industry financial ties or author employment disclosed in published reports of RCTs of pharmacological interventions are transparently reported in meta-analyses published in high-impact general and specialty medicine journals and the Cochrane Database of Systematic Reviews.

Methods

The study, entitled “Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments,” looked at 3 recent meta-analyses of patented pharmacological treatments published January 2009 through October 2009 in each general medicine journal with an impact factor of at least 10; in high-impact journals in each of the 5 specialty medicine areas with the greatest 2008 global therapeutic sales (oncology, cardiology, respiratory medicine, endocrinology, and gastroenterology); and in the Cochrane Database of Systematic Reviews.

 

Then, two investigators independently extracted data on disclosed study funding, author-industry financial ties, and author employment from each meta-analysis, from RCTs included in each meta-analysis, and on whether meta-analyses reported disclosed COIs of included RCTs. 

Results 

 

Of 29 meta-analyses reviewed, which included 509 RCTs, 62.5% (318 of 509) of included RCTs reported funding source. In addition, only 2 meta-analyses (7%) reported RCT funding sources; and 0 reported RCT author-industry ties or employment by the pharmaceutical industry. Of 318 meta-analyzed RCTs that reported funding sources, 219 (69%) were industry funded; and 91 of 132 (69%) that reported author financial disclosures had 1 or more authors with pharmaceutical industry financial ties. 

In 7 of the 29 meta-analyses reviewed, 100% of included RCTs had at least 1 form of disclosed COI (pharmaceutical industry funding, author-industry financial ties, or employment), yet only 1 of these 7 meta-analyses reported RCT funding sources, and 0 reported RCT author-industry ties or employment. Additional findings included:

 

  • At least 1 author of 16 of the 29 meta-analyses (55.2%) reported at least 1 financial tie to the pharmaceutical industry,
  • All of the authors of 12 of the meta-analyses (41.4%) reported 0 financial ties to the pharmaceutical industry
  • Author financial ties were not reported in 1 meta-analysis (3.4%), and
  • Only 1 of the 29 meta-analyses listed authors employed by the pharmaceutical industry.37

Author financial disclosures were reported in only 25.9% (132 of 509) of included RCTs. Among these, 68.9% (91 of 132) reported 1 or more authors having financial ties to the pharmaceutical industry. Author affiliations were reported in 94.7% of included RCTs (482 of 509), including 26.1% (126 of 482) with at least 1 author employed by the pharmaceutical industry.

 

Discussion 

The main finding of the study was that with few exceptions, information on COI disclosed in RCTs is not reported when RCT data are combined in meta-analyses. Based on these results, the authors asserted the “need for complete and transparent disclosure of COI in biomedical research.” They recommended that the PRISMA statement be updated to “require authors of meta-analyses to report funding sources of included RCTs or report that funding sources were not disclosed.” In addition, they recommended that the PRISMA statement consider recommending that meta-analyses report author-industry financial ties disclosed in included RCTs or report that there was no disclosure statement.

 

The authors did note that “the proportion of RCTs reporting author-industry financial ties will likely increase with the recent introduction of ICMJE disclosure guidelines.” The authors also recommend that, “meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias.”

The authors also stated that “meta-analysts should evaluate the potential for bias due to pharmaceutical industry study funding and author-industry financial ties as part of their standard risk of bias assessment,” and that the Cochrane Collaboration should consider formalizing the requirement to assess potential bias from COIs.

One of the limitations from this study is extremely significant. Specifically, while authors asserted the potential problem created by the lack of reporting, “the study was not designed to assess whether reporting of COI from RCTs included in meta-analyses was related to the quality of meta-analyses or whether COIs from included RCTs influenced the results of the meta-analyses reviewed.” In other words, this study had no indication or conclusions about whether the COI’s affected the quality of the studies. Without this information, the value of this study is merely informational.

Ultimately, transparency in all aspects of medical research is important. However, this study did not show that industry involvement or lack of disclosure led to negative quality of meta-analyses. Accordingly, the recommendations contained in this article should be further discussed to meet modern standards of transparency and disclosure to ensure that medical research is conducted at the highest standards to ensure that physicians are given all the information necessary to make informed decisions that will improve patient care.

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