Fact Sheet: Conflict of Interest Disclosure and Journal Supplements in MEDLINE®
Source: National Library of Medicine
Journals indexed for MEDLINE® sometimes publish supplements devoted to a specific topic and that may be financed by profit-making organizations or by organizations representing for-profit interests. The supplements may have a guest editor or may be produced outside of the routine editorial and peer review processes of the journal. Citation of these supplements in MEDLINE may give the appearance that for-profit interests have acquired a place in the scholarly literature while working outside of the usual standards for publication that were considered when the journal was approved for indexing in MEDLINE by the NLM Literature Selection Technical Review Committee. Supplements will thus be cited and indexed for MEDLINE only if certain conditions are met.
If a supplement is sponsored by an outside organization, or reports on a conference or other activity that was sponsored by an outside organization, or is devoted to a special topic that is in any way related to a proprietary product, then the articles in the supplement will not be cited and indexed for MEDLINE unless the supplement includes the disclosure information that is described below. An “outside organization” does not include the organization for which the journal is the publishing organ (e.g., the American Academy of Dermatology and the Journal of the American Academy of Dermatology), nor does it include any U.S. or non-U.S. government agency.
Source: Senator Tom Harkin
Today, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, unveiled a report on the findings of the Committee’s two-year investigation of the for-profit higher education industry. The report outlines widespread problems throughout the sector, as evidenced by the thousands of pages of never-before-released internal documents that education companies submitted to the Committee at Harkin’s request.
“In this report, you will find overwhelming documentation of overpriced tuition, predatory recruiting practices, sky-high dropout rates, billions of taxpayer dollars spent on aggressive marketing and advertising, and companies gaming regulations to maximize profits. These practices are not the exception — they are the norm; they are systemic throughout the industry, with very few exceptions,” Harkin said.
“Justice Louis Brandeis famously said that sunlight is the best disinfectant. As a result of this investigation, a wide range of Americans – including taxpayers, prospective students and their families – are waking up to the troubling realities of this industry. I hope that for-profit colleges will be moved by this final report to reform and focus on students’ success instead of just their financial aid dollars. But that will not be enough — real, bold legislative reforms are critical. We need to know how every student is faring. We need to ensure that resources intended for education are spent productively. We need colleges to provide the services that students need to succeed. And for companies so reliant on taxpayer revenues, we need to start requiring they demonstrate results for students, not just shareholders.”
Source: U.S. House of Representatives (Oversight and Government Reform Committee)
House Oversight and Government Reform Committee Chairman Darrell Issa today released a new report following the Committee’s three year investigation into Countrywide Financial’s “Friends of Angelo” and “VIP Program” that issued discounted mortgages to influential Washington policy figures. The report finds that Countrywide used its VIP Program to aid its lobbying efforts as well as to strengthen its relationship with taxpayer backed Fannie Mae. Countrywide partnered with Fannie Mae in a strategic business alliance that also included joint lobbying efforts.
Physician Payment Sunshine Act
Calls for more transparency and disclosure of payments made by the life sciences industry to health care professionals are creating challenges and opportunities for all parties involved in the delivery of health care. These new rules, such as the Physician Payment Sunshine Act (PPSA) in the U.S., were not intended to eliminate financial interactions between life sciences companies and individual health care providers, but rather to empower patients by providing visibility to those interactions. The hope was that by providing such visibility, patients could question whether the financial interactions might negatively affect their course of treatment.
To better understand how all parties are addressing these requirements and this new era of transparency, Deloitte, in collaboration with Forbes Insights, surveyed 110 U.S. based physicians and 223 global life sciences executives about transparency and these new requirements. The survey, Physician Payment Sunshine Act: Physicians and life sciences companies coming to terms with transparency? indicates that both parties appear to be coming to terms with the concept of transparency, and health care providers and life sciences companies expect to continue collaborating to develop new and more effective treatments for patients. Physicians do have concerns over how the data will be interpreted by the public (e.g., the context), as well as their own understanding of the requirements of the new regulatory environment.
Life sciences company executives, on the other hand, at this time are less focused on the public’s interpretation of the data than the logistics of aggregating and reporting it. As a result, most are still investigating how best to leverage the data for competitive advantage once it becomes publicly available.
SWF Publishes new fact sheet on the International Code of Conduct for Space Activities
Source: Secure World Foundation
SWF has published a new fact sheet on the draft International Code of Conduct for Space Activities (ICOC). The fact sheet describes goals of the original Code of Conduct as proposed by the European Union in 2008 and updated in 2010. The document discusses the various criticisms of the EU proposed Code of Conduct and the transition to the process of developing an International Code of Conduct that would include all interested states.
Retail Pharmacies with Questionable Part D Billing (PDF)
Source: U.S. Department of Health and Human Services, Office of Inspector General
WHY WE DID THIS STUDY
Under the Medicare Part D program, CMS contracts with private insurance companies, known as sponsors, to provide prescription drug coverage to beneficiaries who choose to enroll. In the 6 years since Part D began, OIG has issued several reports that found that Part D had limited safeguards in place.
HOW WE DID THIS STUDY
We based this study on an analysis of prescription drug event records. Sponsors submit these records to CMS for each drug dispensed to beneficiaries enrolled in their plans. Each record contains information about the pharmacy, prescriber, beneficiary, and drug. We analyzed all of the records for drugs billed by retail pharmacies in 2009. We developed eight measures to describe Part D billing and to identify pharmacies with questionable billing.
WHAT WE FOUND
Retail pharmacies each billed Part D an average of nearly $1 million for prescriptions in 2009. Over 2,600 of these pharmacies had questionable billing. These pharmacies had extremely high billing for at least one of the eight measures we developed. For example, many pharmacies billed extremely high dollar amounts or numbers of prescriptions per beneficiary or per prescriber. This could mean that a pharmacy is billing for drugs that are not medically necessary or were never provided to the beneficiary. Although some of this billing may be legitimate, pharmacies that bill for extremely high amounts warrant further scrutiny. The Miami, Los Angeles, and Detroit areas were the most likely to have pharmacies with questionable billing.
WHAT WE RECOMMEND
Together, the findings of this report and prior OIG reports call for a strong response to improve Part D oversight. Therefore, we recommend that CMS: (1) strengthen the Medicare Drug Integrity Contractor’s monitoring of pharmacies and ability to identify pharmacies for further review, (2) provide additional guidance to sponsors on monitoring pharmacy billing, (3) require sponsors to refer potential fraud and abuse incidents that may warrant further investigation, (4) develop risk scores for pharmacies, (5) further strengthen its compliance plan audits, and (6) follow up on the pharmacies identified as having questionable billing. CMS concurred with four of the recommendations and partially concurred with the other two.
The STOCK Act, Insider Trading, and Public Financial Reporting by Federal Officials (PDF)
Source: Congressional Research Service (via Federation of American Scientists)
The STOCK Act (Stop Trading on Congressional Knowledge Act of 2012), which was signed into law on April 4, 2012, affirms and makes explicit the fact that there is no exemption from the “insider trading” laws and regulations for Members of Congress, congressional employees, or any federal officials. The law states that all federal officials have an express “duty” of trust and confidentiality with respect to nonpublic, material information which they may receive in the course of their official duties, and a duty not to use such information to make a private profit. The act also requires expedited public disclosure of covered “financial transactions” by all officials in the executive and legislative branches of the federal government who are covered by the public reporting provisions of the Ethics in Government Act of 1978, as amended. The act requires not only annual public reporting of such transactions, but also public reporting within 30 days of receipt of a notice of a covered financial transaction, however, in no event more than 45 days after such transaction. All public financial disclosure statements filed under the Ethics in Government Act in the legislative and executive branches will eventually be made in electronic form, and will be posted on the Internet where they may be publicly searched, sorted, and, if a log-in protocol is followed, downloaded from official government websites.
In any given month, an estimated 48 percent of Americans take at least one prescription drug. Prescription drugs are crucial for preventing and treating diseases and improving the public’s health, but they can also have unintended harmful effects. Often, their benefits and risks cannot be fully identified until after a drug has been used by a large, diverse group of patients over time, mainly because clinical trials conducted before approval may be too small or too short to detect all possible risks. The passage of the Food and Drug Administration Act in 2007 provides the Food and Drug Administration (FDA) with additional postmarketing regulatory tools to better protect the health of the public, including the authority to require manufacturers to continue studying drugs that are being marketed.To help determine when it is appropriate to require a postmarketing study, which types of studies to require, how to best protect the rights and interests of patients who participate in research, and how to use research in making regulatory decisions, the FDA asked the IOM to evaluate the scientific and ethical aspects of conducting safety studies for approved drugs. The IOM concludes that the FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle. Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent, and proactive. These changes could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.
A Comparison of DSM-IV and DSM-5 Panel Members’ Financial Associations with Industry: A Pernicious Problem Persists
Summary Points+ The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).+ The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.+ Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.+ Gaps in APA’s disclosure policy are identified and recommendations for more stringent safeguards are offered.
Poll: Super PACs Leave Americans Less Likely to Vote
Source: Brennan Center for Justice, New York University School of Law
A new national poll finds that the outsized spending of super PACs and other groups in the 2012 election cycle has given rise to significant, bipartisan fears of corruption and heightened distrust in government. The poll, conducted on behalf of the Brennan Center for Justice at NYU School of Law, also finds that one in four Americans are less likely to vote this year due to fears that candidates cater to the interests of super PAC donors over the public interest.
One in four Americans — 26% — say they are less likely to vote because big donors to super PACs have so much more influence over elected officials than average Americans.
- Less wealthy and less educated Americans were significantly more likely to say they would be less likely to vote because of super PAC influence: 34% of respondents with no more than a high school education, and 34% of those in households with an annual income less than $35,000, said they would be less likely to vote.
- 41% of respondents — including 49% of those who have no more than a high school education and 48% of those with household incomes under $35,000 — believe that their votes don’t matter very much because big donors to super PACs have so much more influence.
The poll found that nearly 70 percent of Americans believe super PAC spending will lead to corruption, while three in four believe that limiting how much corporations, unions and individuals can donate to super PACs would curb corruption. These beliefs are held equally by both Republicans and Democrats.
The 2011 Annual Report on the implementation of the Charter for Protection of Children and Young People reports that nearly all dioceses in the country are totally compliant with the 17-point Charter.It also notes that, as in previous years, the Diocese of Baker, Oregon, and Lincoln, Nebraska, and six eparchies (Eastern rite dioceses) refused to participate in the audits and therefore are found non-compliant.…The report notes that most allegations reported today are of incidents from previous decades. For example, 68 percent of allegations made in 2011, were of incidents from 1960-1984, and the most common time period for allegations was 1975-1979. It also found most of the accused have died or been removed from ministry and many had been accused previously.Three percent (or 21) of the allegations noted in the 2011 report came from current minors.“Of the 21 allegations made by minors, seven were considered credible by law enforcement; three were determined to be false, five were determined to be boundary violations, and three are still under investigation,” the report said. The credibility of three allegations could not be determined.In the same period, “683 adults who were victims/survivors of abuse in the past came forward to report on allegations for the first time.”
+ Full Report (PDF)
The first successful non-regenerative organ transplantation took place in 1954 when Dr. Joseph E. Murray transplanted a kidney from Ronald Herrick to Mr. Herrick’s identical twin Richard, who had been diagnosed with end-stage kidney failure. That time the initial ethical dilemma was whether a healthy donor can be operated in order to save the life of the sick brother. That time it was a miracle that without the use of immunosuppressive drugs, Richard survived with his transplanted kidney for more than eight years. Since then transplantation has become a gradually developing technology. The type and number of transplantable organs have increased, especially since the last decade of the 20th century. By the twenty first century in developed countries the number of available organs, infrastructural, and budgetary means could not keep pace with the increased technological capacity for transplantation. National waiting lists have become full and long, and the number of people who died while waiting in the line has also increased. The other important element that created tension between developed and less developed countries is the globalization, Europeanization and mobilization. Patients no longer feel bound to the capacity of one health care sector. It is easier to travel and it is no longer regarded as an exceptional luxury to seek health care beyond the national frontiers. At the EU level, the European Commission has urged of addressing ethical and legal issues concerning organ transplantation. One of the most important legal instruments was adopted in 2010, the Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation. During this short term project in our work package we attempted to map and to analyze laws, practices, cases, problems with regard the violation of organ transplantation laws. From the minor violation of selecting donor for the recipient to major and severe forms of violation of human rights, such as organ trafficking cases were collected and analyzed. In our small group of this half of the work package we also examined selected laws and practices in order to de-velop some recommendation which may serve for legislation, ethics committees and further research. Our principle methods to this study were legal methods of analysis which were ac-companied with policy analysis, field work, interviews and finally recommendations. We presented our ideas in several conferences, at the workshops of the EULOD Project held in Rot-terdam, Sofia, Munich and in Berlin. We are grateful for the comments that helped us to re-fine methods and arguments.This report is written by researchers working under the Coordination Action on ‘Living Organ Donation in Europe’ (EULOD), funded under the Seventh Framework Programme (FP7) of the European Commission. The first section of this report explores the existing international legal framework to fight against organ trade and trafficking, discussing legal concepts and definitions. The second part analyzes the adopted legislative measures in some selected European countries: Hungary, Moldova, the Netherlands, Romania, and Serbia. The third section presents case studies on illegal organ trade and trafficking. The fourth and final part presents recommendations to improve the effectiveness of efforts to halt organ trade and trafficking.
Western Regions Conference Management Efficiency Report (PDF)
Source: General Services Administration, Office of Inspector General
Our findings included the following:
- GSA spending on conference planning was excessive, wasteful, and in some cases impermissible. To select a venue and plan the conference, GSA employees conducted two “scouting trips,” five off-site planning meetings, and a “dry run.” Six of these planning1events took place at the M Resort (the conference venue) itself. Travel expenses for conference planning totaled $100,405.37, and catering costs totaled over $30,000. GSA spent money on refreshment breaks during the planning meetings, which it had no authority to do, and the cost of catered meals at those meetings exceeded per diem limits.
- GSA failed to follow contracting regulations in many of the procurements associated with the WRC and wasted taxpayer dollars. GSA actions included:
- Disclosing a competitor’s proposal price to a favored contractor;
- Awarding a $58,000 contract to a large business in violation of small-business set-asides;
- Promising the hotel an additional $41,480 in catering charges in exchange for the “concession” of the hotel honoring the government’s lodging cost limit;
- Providing free rooms to a contractor’s employees even though the contract cost included lodging; and
- Disclosing to the team-building contractor the agency’s maximum budget for one day of training, then agreeing to pay the contractor that amount ($75,000).
- GSA incurred excessive and impermissible costs for food at the WRC. GSA spent $146,527.05 on catered food and beverages during the WRC. That spending included $5,600 for three semi-private catered in-room parties and $44 per person daily breakfasts. GSA also paid $30,207.60 – or roughly $95 per person – for the closing reception and dinner; attendees at that dinner included 27 guests of GSA employees and seven contractor employees. GSA obtained repayment for guests’ meals, but only for 23 of the guests and not for the entire cost of the meal.
- GSA incurred impermissible and questionable miscellaneous expenses. These expenses included mementos for attendees, purchases of clothing for GSA employees, and tuxedo rentals.
GSA’s approach to the conference indicates that minimizing expenses was not a goal. The PBS Region 9 Commissioner/Acting Regional Administrator instructed those planning the conference to make it “over the top” and to make it bigger and better than previous conferences. Several suggestions to minimize expenses were ignored.
GSA, in its management response, concurred with our recommendations and outlined the steps it is taking to prevent future waste and abuse.
A Comparison of DSM-IV and DSM-5 Panel Members’ Financial Associations with Industry: A Pernicious Problem Persists
- The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.
- Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.
- Gaps in APA’s disclosure policy are identified and recommendations for more stringent safeguards are offered.
Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database
BackgroundPublication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy.Methods and FindingsFDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant.ConclusionsThe magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs.