21 June 2016


An interesting study of correlation rather than causation is provided by 'Pharmaceutical Industry–Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries' from Colette DeJong, Thomas Aguilar, Chien-Wen Tseng, Grace A. Lin, W. John Boscardin and R. Adams Dudley in (2016) JAMA Intern Medicine.

The authors comment 
The association between industry payments to physicians and prescribing rates of the brand-name medications that are being promoted is controversial. In the United States, industry payment data and Medicare prescribing records recently became publicly available.
To study the association between physicians’ receipt of industry-sponsored meals, which account for roughly 80% of the total number of industry payments, and rates of prescribing the promoted drug to Medicare beneficiaries.
Design, Setting, and Participants
Cross-sectional analysis of industry payment data from the federal Open Payments Program for August 1 through December 31, 2013, and prescribing data for individual physicians from Medicare Part D, for all of 2013.
Participants were physicians who wrote Medicare prescriptions in any of 4 drug classes: statins, cardioselective β-blockers, angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers (ACE inhibitors and ARBs), and selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs). We identified physicians who received industry-sponsored meals promoting the most-prescribed brand-name drug in each class (rosuvastatin, nebivolol, olmesartan, and desvenlafaxine, respectively).
Data analysis was performed from August 20, 2015, to December 15, 2015.
Receipt of an industry-sponsored meal promoting the drug of interest.
Main Outcomes and Measures
Prescribing rates of promoted drugs compared with alternatives in the same class, after adjustment for physician prescribing volume, demographic characteristics, specialty, and practice setting.
A total of 279 669 physicians received 63 524 payments associated with the 4 target drugs. Ninety-five percent of payments were meals, with a mean value of less than $20. Rosuvastatin represented 8.8% (SD, 9.9%) of statin prescriptions; nebivolol represented 3.3% (7.4%) of cardioselective β-blocker prescriptions; olmesartan represented 1.6% (3.9%) of ACE inhibitor and ARB prescriptions; and desvenlafaxine represented 0.6% (2.6%) of SSRI and SNRI prescriptions. Physicians who received a single meal promoting the drug of interest had higher rates of prescribing rosuvastatin over other statins (odds ratio [OR], 1.18; 95% CI, 1.17-1.18), nebivolol over other β-blockers (OR, 1.70; 95% CI, 1.69-1.72), olmesartan over other ACE inhibitors and ARBs (OR, 1.52; 95% CI, 1.51-1.53), and desvenlafaxine over other SSRIs and SNRIs (OR, 2.18; 95% CI, 2.13-2.23). Receipt of additional meals and receipt of meals costing more than $20 were associated with higher relative prescribing rates.
Conclusions and Relevance
Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted. The findings represent an association, not a cause-and-effect relationship.

20 June 2016

FBI Biometrics

The US Government Accounting Office (GAO) has released a 68 page critique of FBI biometrics practice - FACE Recognition Technology:FBI Should Better Ensure Privacy and Accuracy.

The report examines:
1) the FBI's face recognition capabilities; and the extents to which
2) the FBI's use of face recognition adhered to privacy laws and policies and
3) the FBI assessed the accuracy of these capabilities. 
To address these questions, GAO reviewed federal privacy laws, FBI policies, operating manuals, and other documentation on its face recognition capability. GAO interviewed officials from the FBI and other federal and two state agencies that coordinate with the FBI on face recognition.

The report comments
The Department of Justice's (DOJ) Federal Bureau of Investigation (FBI) operates the Next Generation Identification-Interstate Photo System (NGI-IPS)— a face recognition service that allows law enforcement agencies to search a database of over 30 million photos to support criminal investigations. NGI-IPS users include the FBI and selected state and local law enforcement agencies, which can submit search requests to help identify an unknown person using, for example, a photo from a surveillance camera. When a state or local agency submits such a photo, NGI-IPS uses an automated process to return a list of 2 to 50 possible candidate photos from the database, depending on the user's specification. As of December 2015, the FBI has agreements with 7 states to search NGI-IPS, and is working with more states to grant access. In addition to the NGI-IPS, the FBI has an internal unit called Facial Analysis, Comparison and Evaluation (FACE) Services that provides face recognition capabilities, among other things, to support active FBI investigations. FACE Services not only has access to NGI-IPS, but can search or request to search databases owned by the Departments of State and Defense and 16 states, which use their own face recognition systems. Biometric analysts manually review photos before returning at most the top 1 or 2 photos as investigative leads to FBI agents.
DOJ developed a privacy impact assessment (PIA) of NGI-IPS in 2008, as required under the E-Government Act whenever agencies develop technologies that collect personal information. However, the FBI did not update the NGI-IPS PIA in a timely manner when the system underwent significant changes or publish a PIA for FACE Services before that unit began supporting FBI agents. DOJ ultimately approved PIAs for NGI-IPS and FACE Services in September and May 2015, respectively. The timely publishing of PIAs would provide the public with greater assurance that the FBI is evaluating risks to privacy when implementing systems. Similarly, NGI-IPS has been in place since 2011, but DOJ did not publish a System of Records Notice (SORN) that addresses the FBI's use of face recognition capabilities, as required by law, until May 5, 2016, after completion of GAO's review. The timely publishing of a SORN would improve the public's understanding of how NGI uses and protects personal information.
Prior to deploying NGI-IPS, the FBI conducted limited testing to evaluate whether face recognition searches returned matches to persons in the database (the detection rate) within a candidate list of 50, but has not assessed how often errors occur. FBI officials stated that they do not know, and have not tested, the detection rate for candidate list sizes smaller than 50, which users sometimes request from the FBI. By conducting tests to verify that NGI-IPS is accurate for all allowable candidate list sizes, the FBI would have more reasonable assurance that NGI-IPS provides leads that help enhance, rather than hinder, criminal investigations. Additionally, the FBI has not taken steps to determine whether the face recognition systems used by external partners, such as states and federal agencies, are sufficiently accurate for use by FACE Services to support FBI investigations. By taking such steps, the FBI could better ensure the data received from external partners is sufficiently accurate and do not unnecessarily include photos of innocent people as investigative leads.
The GAO comments that 
According to the FBI, [automated face recognition] technology can help law enforcement agencies identify criminals in their investigations. GAO was asked to review the FBI's use of face recognition technology. ... GAO is making six recommendations, including, that the Attorney General determine why PIAs and a SORN were not published as required and implement corrective actions, and for the FBI director to conduct tests to verify that NGI-IPS is accurate and take steps to determine whether systems used by external partners are sufficiently accurate for FBI's use. DOJ agreed with one, partially agreed with two, and disagreed with three of the six recommendations. In response, GAO clarified one recommendation, updated another recommendation, and continues to believe that all six recommendations remain valid as discussed further in this report.
It recommends
To improve transparency and better ensure that face recognition capabilities are being used in accordance with privacy protection laws and policy requirements, we recommend that the Attorney General:
• Assess the PIA development process to determine why PIAs were not published prior to using or updating face recognition capabilities, and implement corrective actions to ensure the timely development, updating, and publishing of PIAs before using or making changes to a system.
• Assess the SORN development process to determine why a SORN was not published that addressed the collection and maintenance of photos accessed and used through NGI for the FBI’s face recognition capabilities prior to using NGI-IPS, and implement corrective actions to ensure SORNs are published before systems become operational.
To better ensure that face recognition capabilities are being used in accordance with privacy protection laws and policy requirements, we recommend that the Director of the Federal Bureau of Investigation conduct audits to determine the extent to which users of NGI-IPS and biometric images specialists in FACE Services are conducting face image searches in accordance with CJIS policy requirements.
To better ensure that face recognition systems are sufficiently accurate, we recommend that the Director of the Federal Bureau of Investigation take the following three actions:
• Conduct tests of NGI-IPS to verify that the system is sufficiently accurate for all allowable candidate list sizes, and ensure that the detection and false positive rate used in the tests are identified.
• Conduct an operational review of NGI-IPS at least annually that includes an assessment of the accuracy of face recognition searches to determine if it is meeting federal, state, and local law enforcement needs and take actions, as necessary, to improve the system.
• Take steps to determine whether each external face recognition system used by FACE Services is sufficiently accurate for the FBI’s use and whether results from those systems should be used to support FBI investigations