Each month, we review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues at the intersection of regulation, therapeutics and law.
To join the PORTAL list-serve and receive these monthly lists directly to your email, click here.
Major Events in the Life Course of New Drugs, 2000-2016.
Beall RF, Hwang TJ, Kesselheim AS.
N Engl J Med. 2019 Mar 14;380(11):e12.
Out-of-pocket Spending on Orphan Drug Prescriptions Among Commercially Insured Adults in 2014.
J Gen Intern Med. 2019 Mar;34(3):338-340.
Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.
Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly JG, Fischer MA, Kesselheim AS, Gagne JJ.
PLoS Med. 2019 Mar 13;16(3):e1002763. eCollection 2019 Mar.
Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing.
Fleischman W, Auth D, Shah ND, Agrawal S, Ross JS.
JAMA Netw Open. 2019 Mar 1;2(3):e191340.
US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?
Trends in Medicaid Prices, Market Share, and Spending on Long-Acting Insulins, 2006-2018.
Hernandez I, Good CB, Shrank WH, Gellad WF.
2. Hernandez I, Good CB, Cutler DM, Gellad WF, Parekh N, Shrank WH. The Contribution of New Product Versus Existing Product Inflation In The Rising Costs of Drugs. Health Aff (Millwood). 2019 Jan;38(1):76-83.
6. Luo J, Khan NF, Manetti T, Rose J, Kaloghlian A, Gadhe B, Jain SH, Gagne JJ, Kesselheim AS. Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes. JAMA. 2019 Jan;321(4):374-384.
8. Schwartz LM, Woloshin S. Medical Marketing in the United States, 1997-2016. JAMA. 2019 Jan 1;321(1):80-96.
1. Beall RF, Kesselheim AS, Sarpatwari A. New Drug Formulations and Their Respective Generic Entry Dates. J Manag Care Spec Pharm. 2019 Feb;25(2):218-224.
2. Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS. Impact Of The Priority Voucher Program On Drug Development For Rare Pediatric Diseases. Health Aff (Millwood). 2019 Feb;38(2):313-319.
3. Rollman JE, Heyward J, Olson L, Lurie P, Sharfstein J, Alexander GC. Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products. JAMA. 2019 Feb 19;321(7):676-685.
5. Sarpatwari A, Curfman G. Mitigating Health Risks of Prescription Drugs: Lessons From FDA Oversight of Opioid Products. JAMA. 2019 Feb 19;321(7):651-653.
1. Beall RF, Darrow JJ, Kesselheim AS. A Method for Approximating Future Entry of Generic Drugs. Value Health. 2018 Dec;21(12):1382-1389.
2. Danzon PM. Differential Pricing of Pharmaceuticals: Theory, Evidence and Emerging Issues. Pharmacoeconomics. 2018 Dec;36(12):1395-1405.
5. Shaw DL, Dhruva SS, Ross JS. Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval. J Manag Care Spec Pharm. 2018 Dec;24(12):1230-1238.
2. Cutler DM. Extending the User Fee Approach to Pharmaceuticals. JAMA. 2018 Oct 16;320(15):1525-1526.
3. Feldman WB, Hey SP, Kesselheim AS. A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway. Health Aff (Millwood). 2018 Oct;37(10):1605-1614.
1. Avorn J, Kesselheim A, Sarpatwari A. The FDA Amendments Act of 2007 - Assessing Its Effects a Decade Later. N Engl J Med. 2018 Sep 20;379(12):1097-1099.
4. Nishikawa G, Prasad V. Diagnostic expansion in clinical trials: myocardial infarction, stroke, cancer recurrence, and metastases may not be the hard endpoints you thought they were. BMJ. 2018 Sep 19;362:k3783.
5. O'Connor JM, Fessele KL, Steiner J, Seidl-Rathkopf K, Carson KR, Nussbaum NC, Yin ES, Adelson KB, Presley CJ, Gross CP. Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials. JAMA Oncol. 2018 Aug 1;4(8):e180798.
6. Sacks CA, Lee CC, Kesselheim AS, Avorn J. Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents. JAMA. 2018 Aug 21;320(7):650-656.
4. Hernandez I, Prasad V, Gellad WF. Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy. JAMA Oncol. 2018 Jul 1;4(7):994-996.
8. Puthumana J, Wallach JD, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation. JAMA. 2018 Jul 17;320(3):301-303.
5. Gerrity MS, Prasad V, Obley AJ. Concerns About the Approval of Nusinersen Sodium by the US Food and Drug Administration. JAMA Intern Med. 2018 Jun 1;178(6):743-744.
2. Gill J, Obley AJ, Prasad V. Direct-to-Consumer Genetic Testing: The Implications of the US FDA's First Marketing Authorization for BRCA Mutation Testing. JAMA. 2018 May 18.
3. Luo J, Kesselheim AS. Delayed Generic Market Saturation After Patent Expiration--A Billion-Dollar Problem. JAMA Intern Med. 2018 May 1;178(5):721-722.
4. Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barbard RT, Darrow JJ, Kesselheim AS. Precision Medicines Have Faster Approvals Based On Fewer and Smaller Trials Than Other Medicines. Health Aff (Millwood). 2018 May;37(5):724-731.
5. Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS. Evaluating the Impact of the Orphan Drug Act's Seven-Year Market Exclusivity Period. Health Aff (Millwood). 2018 May;37(5):732-737.
7. Sinha MS, Kesselheim AS. The Next Forum for Unraveling FDA Off-Label Marketing Rules: State and Federal Legislatures. PLoS Med. 2018 May 8;15(5).
8. Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket Studies Required by the US Food and Drug Administration For New Drugs and Biologics Approved Between 2009 and 2012: Cross Sectional Analysis. BMJ. 2018 May 24;361.
9. Woloshin S, Schwartz LM. Overcoming Overuse: The Way Forward is Not Standing Still. BMJ. 2018 May 22;361.
1. Corrigan-Curay J, McKee AE, Stein P. Breakthrough-Therapy Designation--An FDA Perspective. N Engl J Med. 2018 Apr 12;378(15):1457-1458.
2. Darrow JJ, Avorn J, Kesselheim AS. The FDA Breakthrough-Drug Designation--Four Years of Experience. N Engl J Med. 2018 Apr 12;378(15):1444-1453.
3. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018 Apr 3;361.
4. Goldman AL, McCormick D, Haas JS, Sommers BD. Effects of the ACA's Health Insurance Marketplaces on the Previously Uninsured: A Quasi-Experimental Analysis. Health Aff (Millwood). 2018 Apr;37(4): 591-599.
5. Gupta R, Henkel A, Forman HP, Ross JS. The Impact of Off-Patent Drug Acquisitions on Prices. J Gen Intern Med. 2018 Apr 23.
7. Sampat BN, Shadlen KC. Indian pharmaceutical patent prosecution: The changing role of Section 3(d). PLoS One. 2018 Apr 2;13(4).
1. DeLoughery EP, Prasad V. The US Food and Drug Administration's use of regulator approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation. Ann Oncol. 2018 Mar 1;29(3):527-529.
2. Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study. BMJ. 2018 Mar 19;360.
3. Hwang TJ, Tomasi PA, Bourgeois FT. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study. PLoS Med. 2018 Mar 1;15(3).
4. Lee TT, Kesselheim AS, Kapczynski A. Legal Challenges to State Drug Pricing Laws. JAMA. 2018 Mar 6;319(9):865-866.
6. Wagner J, Marquart J, Ruby J, Lammers A, Mailankody S, Kaestner V, Prasad V. Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study. BMJ. 2018 Mar 7;360.
1. Beall RF, Kesselheim AS. Tertiary Patenting on Drug-Device Combination Products in the United States. Nat Biotechnol. 2018 Feb 6;36(2):142-145.
2. Bothwell LE, Avorn J, Khan NF, Kesselheim AS. Adaptive Design Clinical Trials: A Review of the Literature and ClinicalTrials.gov. BMJ Ope. 2018 Feb 10;8(2):e018320.
6. Powers JH, Evans SR, Kesselheim AS. Studying new antibiotics for multidrug resistant infections: Are today's patients paying for unproved future benefits? BMJ. 2018 Feb 22;360:k587.
8. Wallach JD, Ross JS. Gabapentin approvals, off-label use, and lessons for postmarketing efforts. JAMA. 2018 Feb 27;319(8):776-778.
4. Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS. Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis. JMIR Public Health Surveill. 2018 Jan 5;4(1).
5. Sommers BD, Kesselheim AS. Massachusett's Proposed Medicaid Reforms - Cheaper Drugs and Better Coverage? N Eng J Med. 2018 Jan 11;378(2):109-111.
6. Woloshin S, Schwartz LM, Bagley PJ, Blunt HB, White B. Characteristics of Interim Publications of Randomized Clinical Trials and Comparison With Final Publications. JAMA. 2018 Jan 23;319(4):404-406.
Darrow JJ, Beall RF, Kesselheim AS. Will Inter Partes Review Speed US Generic Drug Entry? Nat. Biotechnol. 2017 Dec 8;35(12):1139-1141.
Darrow JJ, Avorn J, Kesselheim AS. Speed, Safety, and Industry Funding--From PDUFA I to PDUFA VI. N Engl Med. 2017 Dec 7;377(23):2278-2286.
Dave CV, Hartzema A, Kesselheim AS. Prices of Generic Drugs Associated with Numbers of Manufacturers. N Engl J Med. 2017 Dec 28;377(36):2597-2598.
Hwang TJ, Darrow JJ, Kesselheim AS. The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics. JAMA. 2017 Dec 5;318(21):2137-2138.
Miller JE, Wilenzick M, Ritcey N, Ross JS, Mello MM. Measuring Clinical Trial Transparency: An Empirical Analysis of Newly Approved Drugs and Large Pharmaceutical Companies. BMJ Open. 2017 Dec 5;7(12). Epub ahead of print.
Fralick M, Kesselheim AS, Avorn J, Schneeweiss S. Use of Health Care Databases to Support Supplemental Indications of Approved Medications. JAMA Intern Med. 2017 Nov 20. Epub ahead of print.
Hakim A, Gupta R, Ross JS. High Costs of FDA Approval for Formerly Unapproved Marketed Drugs. JAMA. 2017 Nov 13. Epub ahead of print.
Horton DB, Gerhard T, Davidow A, Strom BL. Impact of the Black Triangle Label on Prescribing of New Drugs in the United Kingdom: Lessons for the United States at a Time of Deregulation. Drug Saf. 2017 Nov;26(11):1307-1313.
Kim J, Ross JS, Kapczynski A. Pediatric Exclusivity and Reuglatory Authority: Implications of Amgen v HHS. JAMA. 2017 Nov 8. Epub ahead of print.
Rutkow L, Vernick JS. Emergency Legal Authority and the Opioid Crisis. N Engl J Med. 2017 Nov 15. Epub ahead of print.
Gordon N, Stemmer SM, Greenberg D, Goldstein DA. Trajectories of Injectable Cancer Drug Costs After Launch in the United States. J Clin Oncol. 2017 Oct 10. Epub ahead of print.
Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. J Manag Care Spec Pharm. 2017 Oct;23(10): 1066-1076.
Jonker CJ, van der Berg HM, Kwa MSG, Hoes AW, Mol PGM. Registries Supporting New Drug Applications. Pharmacoepidemiol Drug Saf. 2017 Oct 6. Epub ahead of print.
Sarpatwari A, Choudhry NK. Recalibrating Privacy Protections to Promote Patient Engagement. N Engl J Med. 2017 Oct 19;377(16):1509-1511.
Bucher Bartelson B, Le Lait MC, Green JL, Cepeda MS, Coplan PM, Maziere JY, Wedin GP, Dart RC. Changes in Misuse and Abuse of Prescription Opioids Following Implementation of Extended-Release and Long-Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy. Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1061-1070. Epub 2017 Jul 31.
Hey SP, Cohen IG, Adashi EY, Kesselheim AS. Influence, Integrity, and the FDA: An Ethical Framework. Science. 2017 Sep 1;357(6354):876-877.
Kesselheim AS, Sinha MS, Avorn J. Determinants of Market Exclusivity for Prescription Drugs in the United States. JAMA Intern Med. 2017 Nov 1;177(11):1658-1664. Epub 2017 Sep 11.
Mostaghim SR, Gagne JJ, Kesselheim AS. Safety Related Label Changes from New Drugs After Approval in the US through Expedited Regulatory Pathways: Retrospective Cohort Study. BMJ. 2017 Sep 7;358:j3837.
Woloshin S, Schwartz LM, White B, Moore TJ. The Fate of FDA Postapproval Studies. N Engl J Med. 2017 Sep 21;377(12):1114-1117.
Kashoki M, Lee C, Stein P. Letter to the Editor: FDA Oversight of Postmarketing Studies. N Engl J Med. 2017 Sep 21;377(12):1201-1202.
Alexander GC, Ballreich J, Socal MP, Karmarkar T, Trujillo A, Greene J, Sharfstein J, Anderson G. Reducing Branded Prescription Drug Prices: A Review of Policy Options. Pharmacotherapy. 2017 Aug 14. Epub ahead of print.
Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study. Ann Intern Med. 2017 Aug 1;167(3):145-151.
Horton DB, Gerhard T, Davidow A, Strom BL. Impact of the Black Triangle Label on Prescribing of New Drugs in the United Kingdom: Lessons for the United States at a Time of Deregulation. Pharmacoepidemiol Drug Saf. 2017 Aug 31. Epub ahead of print.
Hwang TJ, Franklin JM, Kesselheim AS. Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development. Clin Pharmacol Ther. 2017 Aug;102(2):290-296.
Naci H, Smalley KR, Kesselheim AS. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. JAMA. 2017 Aug 15;318(7):626-636.
Sommers BD, Gawande AA, Baicker K. Health Insurance Coverage and Health--What the Recent Evidence Tells Us. N Eng J Med. 2017 Aug 10;377(6):586-593.
Zheng SY, Dhruva SS, Redberg RF. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. JAMA. 2017 Aug 15;318(7):619-625.
Fralick M, Avorn J, Kesselheim AS. The price of crossing the border for medications. N Eng J Med. 2017 Jul 27;377(4):311-313.
Jain N, Hwang TJ, Franklin JM, Kesselheim AS. Association of the priority review voucher with neglected tropical disease drug and vaccine development. JAMA. 2017 Jul 25;318(4):388-389.
Kemp R, Prasad V. Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused? BMC Med. 2017 Jul 21;15(1):134.
Miller JE, Ross JS, Moch KI, Caplan AL. Characterizing expanded access and compassionate use programs for experimental drugs. BMC Res Notes. 2017 Jul 28;10(1):350.
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials. 2017 Jul 18;18(1):333.
Chimonas S, DeVito NJ, Rothman DJ. Bringing Transparency to Medicine: Exploring Physicians' Views and Experiences of the Sunshine Act. Am J Bioeth. 2017;17(6):4-18.
Dong K, Boehm G, Zheng Q. Economic Impacts of the Generic Drug User Fee Act Fee Structure. Value Health. 2017;20(6):792-8.
 Hey SP, Franklin JM, Avorn J, Kesselheim AS. Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors. Circ Cardiovasc Qual Outcomes. 2017 Jun;10(6).
't Hoen EFM, Boulet P, Baker BK. Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation. J Pharm Policy Pract. 2017 Jun 28;10:19.
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA. 2017 May 9;317(18):1854-1863.
Gellad WF, Kesselheim AS. Accelerated Approval and Expensive Drugs - A Challenging Combination. N Engl J Med. 2017 May 25;376(21):2001-2004.
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ. 2017 May 3;357:j1680.
Sacks CA, Avorn J, Kesselheim AS. The Failure of Solanezumab - How the FDA Saved Taxpayers Billions. N Engl J Med. 2017 May 4;376(18):1706-1708.
Sommers BD, Maylone B, Blendon RJ, Orav EJ, Epstein AM. Three-Year Impacts of the Affordable Care Act: Improved Medical Care and Health Among Low-Income Adults. Health Aff (Millwood). 2017 Jun 1;36(6): 1119-1128.
Davies BJ, Hwang TJ, Kesselheim AS. Ensuring Access to Injectable Generic Drugs – The Case of Intravesical BCG for Bladder Cancer. N Engl J Med. 2017;376(15):1401-3.
Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents – FDA versus EMA, 2011-2015. N Engl J Med. 2017;376(14):1386-7.
Gyawali B, Prasad V. Drugs that Lack Single-Agent Activity: Are They Worth Pursuing in Combination? Nat Rev Clin Oncol. 2017;14(4):193-4.
Polinski JM, Howell B, Gagnon MA, Kymes SM, Brennan TA, Shrank WH. Impact of CVS Pharmacy's Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014). Am J Public Health. 2017;107(4):556-62.
Califf RM. Warning About Shortcuts in Drug Development. J Am Heart Assoc. 2017 Mar 21;6(3).
Hey SP, Kesselheim AS. Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations. Hastings Cent Rep. 2017;47(2):16-20.
Layton JB, Kim Y, Alexander GC, Emery SL. Association Between Direct-to-Consumer Advertising and Testosterone Testing and Initiation in the United States, 2009-2013. JAMA. 2017;317(11):1159-1166.
Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open. 2017;7(2):e014582.
Luo J, Kesselheim AS, Greene J, Lipska KJ. Strategies to improve the affordability of insulin in the USA. Lancet Diabetes Endocrinol. 2017;5(3):158-159.
Spelsberg A, Prugger C, Doshi P, Ostrowski K, Witte T, Hüsgen D, Keil U. Working Group on Health and Working Group on Freedom of Information, Transparency International Deutschland eV. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ. 2017;356:j337.
Wong J, Motulsky A, Abrahamowicz M, Eguale T, Buckeridge DL, Tamblyn R. Off-label indications for antidepressants in primary care: descriptive study of prescriptions from an indication based electronic prescribing system. BMJ. 2017;356:j603.
Ahn R, Woodbridge A, Abraham A, Saba S, Korenstein D, Madden E, Boscardin WJ, Keyhani S. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study. BMJ. 2017;356:i6770.
Kesselheim AS, Treasure CL, Joffe S. Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage. PLoS Med. 2017;14(1):e1002190.
Califf RM, Robb MA, Bindman AB, Briggs JP, Collins FS, Conway PH, et al. Transforming Evidence Generation to Support Health and Health Care Decisions. N Engl J Med. 2016;375(24):2395-2400.
Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone – Risks to Efforts to Stem Overdose Deaths. N Engl J Med. 2016;375(23):2213-2215.
Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M. Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan. Clin Pharmacol Ther. 2016;100(6):626-632.
Knopf K, Baum M, Shimp WS, Bennett CL, Faith D, Fishman ML, Hrushesky WJ. Interpretation of surrogate endpoints in the era of the 21st Century Cures Act. BMJ. 2016;355:i6286.
Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016;375(24):2313-2315.
Sinha MS, Kesselheim AS. Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorg Med Chem. 2016;24(24):6446-6451.
Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016;31(12):1482-1489.
Abola MV, Prasad V. Industry Funding of Cancer Patient Advocacy Organizations. Mayo Clin Proc. 2016;91(11):1668-1670.
Xu J, Gill R, Cruz M, Staffa J, Lurie P. Effect of US Food and Drug Administration-Approved Pediatric Labeling on Dispensing of Extended-Release Oxycodone in the Outpatient Retail Setting. JAMA Pediatr. 2016;170(11):1103-1104.
Doshi P. Is this trial misreported? Truth seeking in the burgeoning age of trial transparency. 2016;355:i5543.
Sommers BD, Blendon RJ, Orav EJ, Epstein AM. Changes in Utilization and Health Among Low-Income Adults After Medicaid Expansion or Expanded Private Insurance. JAMA Intern Med. 2016;176(10):1501-9.
Bouvy JC, Huinink L, De Bruin ML. Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012. Pharmacoepidemiol Drug Saf. 2016;25(9):1004-14.
Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016;176(9):1391-3.
Kleijnen S, Lipska I, Leonardo Alves T, Meijboom K, Elsada A, Vervölgyi V, d'Andon A, Timoney A, Leufkens HG, De Boer A, Goettsch WG. Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries. Ann Oncol. 2016;27(9):1768-75.
Mailankody S, Prasad V. Thinking Systematically About the Off-Label Use of Cancer Drugs and Combinations for Patients Who Have Exhausted Proven Therapies. Oncologist. 2016;21(9):1031-2.
Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016;316(10):1093-103.
Chang HY, Lyapustina T, Rutkow L, Daubresse M, Richey M, Faul M, Stuart EA, Alexander GC. Impact of prescription drug monitoring programs and pill mill laws on high-risk opioid prescribers: A comparative interrupted time series analysis. Drug Alcohol Depend. 2016;165:1-8.
Chambers JD, Rane PB, Neumann PJ. The impact of formulary drug exclusion policies on patients and healthcare costs. Am J Manag Care. 2016;22(8):524-31.
Doshi JA, Lim R, Li P, Young PP, Lawnicki VF, State JJ, Troxel AB, Volpp KG. A Synchronized Prescription Refill Program Improved Medication Adherence. Health Aff. 2016;35(8):1504-12.
Fleischman W, Agrawal S, King M, Venkatesh AK, Krumholz HM, McKee D, Brown D, Ross JS. Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. BMJ. 2016;354:i4189.
Hey SP, Kesselheim AS. The FDA, Juno Therapeutics, and the ethical imperative of transparency. BMJ. 2016;354:i4435.
Kesselheim AS, Avorn J, Sarpatwari A. The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. JAMA. 2016;316(8):858-71.
Sarpatwari A, Gagne JJ. Balancing benefits and harms: privacy protection policies. Pharmacoepidemiol Drug Saf. 2016;25(8):969-71.
Gabler NB, Duan N, Raneses E, Suttner L, Ciarametaro M, Cooney E, Dubois RW, Halpern SD, Kravitz RL. No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals. Trials. 2016;17(1):320.
Gagne JJ, Han X, Hennessy S, Leonard CE, Chrischilles EA, Carnahan RM, Wang SV, Fuller C, Iyer A, Katcoff H, Woodworth TS, Archdeacon P, Meyer TE, Schneeweiss S, Toh S. Successful comparison of US Food and Drug Administration Sentinel analysis tools to traditional approaches in quantifying a known drug-adverse event association. Clin Pharmacol Ther. 2016 Jul 14. [Epub ahead of print].
Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016 Jul 18. [Epub ahead of print].
Haffner ME. The history of orphan drug regulation – US and Beyond. Clin Pharmacol Ther. 2016 Jul 9. [Epub ahead of print].
Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU. Br J Clin Pharmacol. 2016;82(1):213-26.
Luo J, Kesselheim AS. Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad. AMA J Ethics. 2016;18(7):727-35.
Mailankody S, Prasad V. Implications of Proposed Medicare Reforms to Counteract High Cancer Drug Prices. JAMA. 2016;316(3):271-2.
van Staa TP, Goldacre B, Buchan I, Smeeth L. Big health data: the need to earn public trust. BMJ. 2016 Jul 14;354:i3636.
Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the Gold Standard–Lessons from the History of RCTs. N Engl J Med. 2016;374(22):2175-81.
Hwang TJ, Sokolov E, Franklin JM, Kesselheim AS. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ. 2016;353:i3323.
Kesselheim AS, Gagne JJ, Eddings W, Franklin JM, Ross KM, Fulchino LA, Campbell EG. Prevalence and Predictors of Generic Drug Skepticism Among Physicians: Results of a National Survey. JAMA Intern Med. 2016;176(6):845-7.
Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG. Variations in Patients' Perceptions and Use of Generic Drugs: Results of a National Survey. J Gen Intern Med. 2016;31(6):609-14.
Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):713-8.
Sarpatwari A, Kesselheim AS. Navigating the Dermatological Drug Cost Curve. JAMA. 2016;315(24):2724-5.
Sarpatwari A, Avorn J, Kesselheim AS. State Initiatives to Control Medication Costs–Can Transparency Legislation Help? N Engl J Med. 2016;374(24):2301-4.
Eichler HG, Hurts H, Broich K, Rasi G. Drug Regulation and Pricing–Can Regulators Influence Affordability? New Engl J Med. 2016 May 12;374(19):1807-9.
Kapczynski A, Kesselheim AS. 'Government Patent Use': A Legal Approach To Reducing Drug Spending. Health Aff. 2016 May 1;35(5):791-7.
Outterson K, McDonnell A. Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy. Health Aff. 2016 May 1;35(5):784-90.
Califf RM, Woodcock J, Ostroff S. A Proactive Response to Prescription Opioid Abuse. N Engl J Med. 2016 Apr 14;374(15):1480-5.
Goldacre B, Gray J. OpenTrials: towards a collaborative open database of all available information on all clinical trials. 2016 Apr 8;17(1):164.
Kesselheim AS, Woloshin S, Eddings W, Franklin JM, Ross KM, Schwartz LM. Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation. 2016 Apr 12;315(14):1516-8.
Rex JH, Outterson K. Antibiotic reimbursement in a model delinked from sales: a benchmark-based worldwide approach. Lancet Infect Dis. 2016 Apr;16(4):500-5.
Woloshin S, Schwartz LM. US Food and Drug Administration Approval of Flibanserin: Even the Score Does Not Add Up. JAMA Intern Med. 2016 Apr 1;176(4):439-42.
Hey SP, Kesselheim AS. An Uninformative Truth: The Logic of Amarin's Off-Label Promotion. PLoS Med. 2016 Mar 15;13(3):e1001978.
Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of post-marketing studies of conditionally authorised medicines in the EU. Br J Clin Pharmacol. 2016 Mar 18. [Epub ahead of print].
Kapczynski A. Free Speech and Pharmaceutical Regulation-Fishy Business. JAMA Intern Med. 2016 Mar 1;176(3):295-6.
Massey PR, Wang R, Prasad V, Bates SE, Fojo T. Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting. 2016 Mar;21(3):261-8.
Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. 2016 Feb 17;352:i637.
Doshi P, Jefferson T. Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency. 2016 Feb 11;17(1):78.
Hwang TJ, Kesselheim AS. Vaccine Pipeline Has Grown During The Past Two Decades With More Early-Stage Trials From Small And Medium-Size Companies. Health Aff (Millwood). 2016 Feb 1;35(2):219-26.
Lyapustina T, Rutkow L, Chang HY, Daubresse M, Ramji AF, Faul M, Stuart EA, Alexander GC. Effect of a "pill mill" law on opioid prescribing and utilization: The case of Texas. Drug Alcohol Depend. 2016 Feb 1;159:190-7.
Sarpatwari A, Kesselheim AS. The Case for Reforming Drug Naming: Should Brand Name Trademark Protections Expire upon Generic Entry? PLoS Med. 2016 Feb 9;13(2):e1001955.
Arnold DG, Troyer JL. Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation? J Health Polit Policy Law. 2016 Jan 5. [Epub ahead of print].
Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Jan;17(1):31.
Choudhry NK, Denberg TD, Qaseem A; Clinical Guidelines Committee of the American College of Physicians. Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med. 2016;164(1):41-9.
Greene JA, Anderson G, Sharfstein JM. Role of the FDA in Affordability of Off-Patent Pharmaceuticals. 2016 Jan 4. [Epub ahead of print].
Kesselheim AS, Hwang TJ. Breakthrough Medical Devices and the 21st Century Cures Act. Ann Intern Med. 2016 Jan 19. [Epub ahead of print].
Lieberman DA, Polinski JM, Choudhry NK, Avorn J, Fischer MA. Medicaid prescription limits: policy trends and comparative impact on utilization. BMC Health Serv Res. 2016;16(1):15.
Vilhelmsson A, Davis C, Mulinari S. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012. PLoS Med. 2016;13(1):e1001945.
Wu MH, Bartz D, Avorn J, Seeger JD. Trends in Direct-to-Consumer Advertising of Prescription Contraceptives. 2016 Jan 22. [Epub ahead of print].
Dhruva SS, Prasad V. Application of Medicare's New Technology Add-on Payment Program for Blinatumomab. JAMA Oncol. 2015 Dec 30:1-2. [Epub ahead of print].
Hunter NL, O'Callaghan KM, Califf RM. Engaging Patients Across the Spectrum of Medical Product Development: View From the US Food and Drug Administration. 2015 Dec 15;314(23):2499-500.
Langedijk J, Whitehead CJ, Slijkerman DS, Leufkens HG, Schutjens MD, Mantel-Teeuwisse AK. Extensions of indication throughout the drug product lifecycle: a quantitative analysis. Drug Discov Today. 2015 Dec 2. [Epub ahead of print].
Neumann PJ, Cohen JT. Measuring the Value of Prescription Drugs. N Engl J Med. 2015 Dec 31;373(27):2595-7.
Shaw DL, Ross JS. US Federal Government Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing. AMA J Ethics. 2015 Dec 1;17(12):1152-9.
Treasure CL, Avorn J, Kesselheim AS. Do March-In Rights Ensure Access to Medical Products Arising From Federally Funded Research? A Qualitative Study. Milbank Q. 2015 Dec;93(4):761-87.
Yeh JS, Austad KE, Franklin JM, Chimonas S, Campbell EG, Avorn J, Kesselheim AS. Medical Schools' Industry Interaction Policies Not Associated With Trainees' Self-Reported Behavior as Residents: Results of a National Survey. J Grad Med Educ. 2015 Dec;7(4):595-602.
Årdal C, Outterson K, Hoffman SJ, Ghafur A, Sharland M, Ranganathan N, Smith R, Zorzet A, Cohn J, Pittet D, Daulaire N, Morel C, Rizvi Z, Balasegaram M, Dar OA, Heymann DL, Holmes AH, Moore LS, Laxminarayan R, Mendelson M, Røttingen JA. International cooperation to improve access to and sustain effectiveness of antimicrobials. Lancet. 2015 Nov 17. [Epub ahead of print].
Eguale T, Buckeridge DL, Verma A, Winslade NE, Benedetti A, Hanley JA, Tamblyn R. Association of off-label drug use and adverse drug events in an adult population. JAMA Intern Med. 2015 Nov 2. [Epub ahead of print].
Gagne JJ, Kesselheim AS, Choudhry NK, Polinski JM, Hutchins D, Matlin OS, Brennan TA, Avorn J, Shrank WH. Comparative effectiveness of generic versus brand-name antiepileptic medications. Epilepsy Behav. 2015;52(Pt A):14-8.
Hung A, Sieluk J, Doshi P. The untapped potential of pharmacy leaflets for informing patients about drug benefits and risks. JAMA Intern Med. 2015 Nov 30. [Epub ahead of print].
Kesselheim AS, Hwang TJ, Franklin JM. Two decades of new drug development for central nervous system disorders. Nat Rev Drug Discov. 2015 Nov 20. [Epub ahead of print].
Krishnamurti T, Woloshin S, Schwartz LM, Fischhoff B. A randomized trial testing US Food and Drug Administration "breakthrough" language. JAMA Intern Med. 2015;175(11):1856-8.
Palasik B, Sieluk J, dosReis S, Doshi P. Stimulant use and cardiovascular risk among children and adolescents with ADHD: what product labeling does, or does not, tell us. Value Health. 2015;18(7):A747.
Abola MV, Prasad V. The Use of Superlatives in Cancer Research. JAMA Oncol. 2015 Oct 29. [Epub ahead of print].
Downing NS, Krumholz HM, Ross JS, Shah ND. Regulatory watch: Characterizing the US FDA's approach to promoting transformative innovation. Nat Rev Drug Discov. 2015 Oct 5. [Epub ahead of print].
Ioannidis JP, Fanelli D, Dunne DD, Goodman SN. Meta-research: Evaluation and Improvement of Research Methods and Practices. PLoS Biol. 2015 Oct 2; 13(10):e1002264.
Kesselheim AS, Maggs LR, Sarpatwari A. Experience With the Priority Review Voucher Program for Drug Development. JAMA. 2015 Oct 27; 314(16):1687-8.
Kim C, Prasad V. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals. JAMA Intern Med. 2015 Oct 19. [Epub ahead of print].
Langedijk J, Ebbers HC, Mantel-Teeuwisse AK, Kruger-Peters AG, Leufkens HG. Licensing failure in the European decentralised procedure. Eur J Pharm Sci. 2015 Oct 19. [Epub ahead of print].
Luo J, Kesselheim AS. Evolution of insulin patents and market exclusivities in the USA. Lancet Diabetes Endocrinol. 2015 Oct 6. [Epub ahead of print].
Whicher DM, Miller JE, Dunham KM, Joffe S. Gatekeepers for pragmatic clinical trials. Clin Trials. 2015 Oct; 12(5):442-8.
Anderson TS, Good CB, Gellad WF. Prevalence and compensation of academic leaders, professors, and trustees on publicly traded US healthcare company boards of directors: cross sectional study. BMJ. Sep 29 2015;351:h4826.
Avorn J, Sarpatwari A, Kesselheim AS. Forbidden and Permitted Statements about Medications–Loosening the Rules. New Eng J Med. Sep 3 2015;373(10):967-973.
Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials. Sep 15 2015. [Epub ahead of print].
Doshi P. No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility. BMJ. Sep 16 2015;351:h4629.
Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. Sep 23 2015;351:h4633.
Kim Y, Kornfield R, Shi Y, et al. Effects of Televised Direct-to-Consumer Advertising for Varenicline on Prescription Dispensing in the United States, 2006-2009. Nicotine Tob Res. Sep 18 2015. [Epub ahead of print].
Krishnamurti T, Woloshin S, Schwartz LM, Fischhoff B. A Randomized Trial Testing US Food and Drug Administration "Breakthrough" Language. JAMA Intern Med. Sep 21 2015. [Epub ahead of print].
Mendes D, Alves C, Batel-Marques F. Number needed to harm in the post-marketing safety evaluation: results for rosiglitazone and pioglitazone. Pharmacoepidemiol Drug Saf. Sep 16 2015. [Epub ahead of print].
Podolsky SH, Powers JH, 3rd. Regulating Antibiotics in an Era of Resistance: The Historical Basis and Continued Need for Adequate and Well-Controlled Investigations. Annals Intern Med. Sep 1 2015;163(5):386-388.
Wang B, Kesselheim AS. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review. BMJ. Sep 23 2015;351:h4679.
Chambers JD, Chenoweth M, Thorat T, Neumann PJ. Private Payers Disagree With Medicare Over Medical Device Coverage About Half The Time. Health Aff (Millwood). 2015 Aug 1; 34(8):1376-82.
Djulbegovic B. Value-Based Cancer Care and the Excessive Cost of Drugs. JAMA Oncol. 2015 Aug 27. [Epub ahead of print].
Greene JA, Watkins ES. The Vernacular of Risk – Rethinking Direct-to-Consumer Advertising of Pharmaceuticals. N Engl J Med. 2015 Aug 19. [Epub ahead of print].
Luo J, Avorn J, Kesselheim AS. Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014. JAMA Intern Med. 2015 Aug 24. [Epub ahead of print].
Luo J, Kesselheim AS. The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines. JAMA. 2015 Aug 20. [Epub ahead of print].
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA. 2015 Aug 11; 314(6):604-12.
Robertson CT. New DTCA Guidance – Enough to Empower Consumers? N Engl J Med. 2015 Aug 19. [Epub ahead of print].
Rutkow L, Chang HY, Daubresse M, Webster DW, Stuart EA, Alexander GC. Effect of Florida's Prescription Drug Monitoring Program and Pill Mill Laws on Opioid Prescribing and Use. JAMA Intern Med. 2015 Aug 17. [Epub ahead of print].
Schick A, Miller KL, Lanthier M, Woodcock J. Regulatory watch: What drives differences in review times among CDER divisions? Nat Rev Drug Discov. 2015 Aug 21. [Epub ahead of print].
Campbell EG, Vogeli C, Rao SR, Abraham M, Pierson R, Applebaum S. Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014. JAMA Intern Med. 2015 Jul 13. [Epub ahead of print].
Eichler HG, Thomson A, Eichler I, Schneeweiss S. Assessing the relative efficacy of new drugs: an emerging opportunity. Nat Rev Drug Discov. 2015 Jul 1; 14(7):443-4.
Flacco ME, Manzoli L, Boccia S, et al. Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor. J Clin Epidemiol. 2015 Jul; 68(7):811-20.
Gellad WF, Flynn KE, Alexander GC. Evaluation of Flibanserin: Science and Advocacy at the FDA. JAMA. 2015 Jul 6. [Epub ahead of print].
Ma P, Marinovic I, Karaca-Mandic P. Drug Manufacturers' Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration. JAMA Intern Med. 2015 Jul 27. [Epub ahead of print].
Sampat BN, Shadlen KC. Patent watch: Drug patenting in India: looking back and looking forward. Nat Rev Drug Discov. 2015 Jul 17. [Epub ahead of print].
Sharfstein JM, Kesselheim AS. The Safety of Prescription Drugs. JAMA. 2015 Jul 21; 314(3):233-4.
Avorn J and Kesselheim AS. The 21st Century Cures Act – Will It Take Us Back in Time? New Engl J Med. 2015 June 25;372(26):2473-2475.
Doshi P. FDA drug summaries: a simplification too far? 2015 June 12; 350:h3135.
Lanini S, Zumla A, Ioannidis JPA, et al. Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa? The Lancet Infectious Diseases. 2015 June;15(6):738-745.
Lurie P, Chahal HS, Sigelman DW, Stacy S, Sclar J, Ddamulira B.Comparison of content of FDA letters not approving applications for new drugs and associated public announcement from sponsors: cross sectional study. 2015 June 10;350:h2758.
Ruger JP, Ruger TW, Annas GJ. The Elusive Right to Health Care under U.S. Law. New Engl J Med. 2015 June 25;372(26):2558-2563.
Avorn J. The $2.6 billion pill–methodologic and policy considerations. N Engl J Med. 2015 May 14;372(20):1877-1879.
Iglehart JK, Sommers BD. Medicaid at 50–from welfare program to nation's largest health insurer. N Engl J Med. 2015 May 28;372(22):2152-2159.
Ito K, Avorn J, Shrank WH, Toscano M, Spettel C, Brennan T, Choudhry NK. Long-term cost-effectiveness of providing full coverage for preventive medications after myocardial infarction. Circ Cardiovasc Qual Outcomes. 2015 May;8(3):252-259.
Kornfield R, Alexander GC, Qato DM, Kim Y, Hirsch JD, Emery SL. Trends in exposure to televised prescription drug advertising, 2003-2011. Am J Prev Med. 2015 May;48(5):575-579.
Lexchin J. Health Canada's use of its priority review process for new drugs: a cohort study. BMJ Open. 2015 May 11;5(5):e006816.
Goldacre B. How to get all trials reported: audit, better data, and individual accountability. PLoS Med. 2015 Apr 14;12(4):e1001821.
Light DW, Lexchin J. Why do cancer drugs get such an easy ride? 2015 Apr 23;350:h2068.
McClellan MB, Daniel GW, Dickson D, Perlmutter J, Berger DP, Miller V, Nussbaum S, Malin J, Romine MH, Schilsky RL. Improving evidence developed from population-level experience with targeted agents. Clin Pharmacol Ther. 2015 May;97(5):478-87. Epub 2015 Apr 3.
Ross JS, Dzara K, Downing NS. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs. Health Aff (Millwood). 2015 Apr 1;34(4):681-88.
Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015 Mar 12;372(11):1031-1039.
Gopal AD, Desai NR, Tse T, Ross JS. Reporting of noninferiority trials in ClinicalTrials.gov and corresponding publications. JAMA. 2015 Mar 17;313(11):1163-1165.
Greene JA, Riggs KR. Why is there no generic insulin? Historical origins of a modern problem. N Engl J Med. 2015 Mar 19;372(12):1171-1175.
Najafzadeh M, Andersson K, Shrank WH, Krumme AA, Matlin OS, Brennan T, Avorn J, Choudhry NK. Cost-effectiveness of novel regimens for the treatment of hepatitis C virus. Ann Intern Med. 2015 Mar 17;162(6):407-419.
Parekh A, Buckman-Garner S, McCune S, ONeill R, Geanacopoulos M, Amur S, Clingman C, Barratt R, Rocca M, Hills I, Woodcock J. Catalyzing the critical path initiative: FDA's progress in drug development activities. Clin Pharmacol Ther. 2015 Mar;97(3):221-233.
Sarpatwari A, Choudhry NK, Avorn J, Kesselheim AS. Paying physicians to prescribe generic drugs and follow-on biologics in the United States. PLoS Med. 2015 Mar 17;12(3):e1001802.
Weissman JS, Westrich K, Hargraves JL, Pearson SD, Dubois R, Emond S, Olufajo OA. Translating comparative effectiveness research into Medicaid payment policy: views from medical and pharmacy directors. J Comp Eff Res. 2015 Mar;4(2):79-88.
Chambers JD, Chenoweth M, Cangelosi MJ, Pyo J, Cohen JT, Neumann PJ. Medicare is scrutinizing evidence more tightly for national coverage determinations. Health Aff (Millwood). 2015 Feb 1;34(2):253-260.
Falit BP, Singh SC, Brennan TA. Biosimilar competition in the United States: statutory incentives, payers, and pharmacy benefit managers. Health Aff (Millwood). 2015 Feb 1;34(2):294-301.
Hwang CS, Turner LW, Kruszewski SP, Kolodny A, Alexander GC. Prescription drug abuse: a national survey of primary care physicians. JAMA Intern Med. 2015 Feb 1;175(2):302-304.
Kesselheim AS, Tan YT, Avorn J. The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs. Health Aff (Millwood). 2015 Feb 1;34(2):286-293.
Outterson K, Powers JH, Daniel GW, McClellan MB. Repairing the broken market for antibiotic innovation. Health Aff (Millwood). 2015 Feb 1;34(2):277-285.
Rising JP, Moscovitch B. Characteristics of pivotal trials and FDA review of innovative devices. PLoS One. 2015 Feb 4;10(2):e0117235.
Sarpatwari A, Franklin J, Avorn J, Seeger J, Landon J, Kesselheim A. Are risk evaluation and mitigation strategies associated with less off-label use of medications? The case of immune thrombocytopenia. Clin Pharmacol Ther. 2015 Feb;97(2):186-193.
Zetterqvist AV, Merlo J, Mulinari S. Complaints, complainants, and rulings regarding drug promotion in the United kingdom and sweden 2004-2012: a quantitative and qualitative study of pharmaceutical industry self-regulation. PLoS Med. 2015 Feb 17;12(2):e1001785.
Aliferis L. Variation in prices for various medical tests and procedures. JAMA Intern Med. 2015 Jan 1;175(1):11-12.
Chambers JD, Thorat T, Pyo J, Neumann PJ. The lag from FDA approval to published cost-utility evidence. Expert Rev Pharmacoecon Outcomes Res. 2015 Jan 12:1-4.
Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS. Practical, legal, and ethical issues in expanded access to investigational drugs. New Eng J Med. 2015 Jan 15;372(3):279-286.
Drazen JM. Sharing individual patient data from clinical trials. New Eng J Med. 2015 Jan 15;372(3):201-202.
Jacobs DB, Sommers BD. Using drugs to discriminate—adverse selection in the insurance marketplace. New Eng J Med. 2015 Jan 29;372(5):399-402.
Moses H 3rd, Matheson DH, Cairns-Smith S, George BP, Palisch C, Dorsey ER. The anatomy of medical research: US and international comparisons. BMJ. 2015 Jan 28;350:h522. JAMA. 2015 Jan 13;313(2):174-189.
Rajan PV, Kramer DB, Kesselheim AS. Medical device postapproval safety monitoring: where does the United States stand? Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):124-131.
Ryskina KL, Halpern SD, Minyanou NS, Goold SD, Tilburt JC. The Role of Training Environment Care Intensity in US Physician Cost Consciousness. Mayo Clin Proc. 2015 Jan 26. pii: S0025-6196(14)01083-1090.
Bonini S, Eichler HG, Wathion N, Rasi G. Transparency and the European Medicines Agency—sharing of clinical trial data. N Engl J Med. 2014 Dec 25;371(26):2452-2455.
Fischer MA, Choudhry NK, Bykov K, Brill G, Bopp G, Wurst AM, Shrank WH. Pharmacy-based interventions to reduce primary medication nonadherence to cardiovascular medications. Med Care. 2014 Dec;52(12):1050-1054.
Notenboom K, Beers E, van Riet-Nales DA, Egberts TC, Leufkens HG, Jansen PA, Bouvy ML. Practical Problems with Medication Use that Older People Experience: A Qualitative Study. J Am Geriatr Soc. 2014 Dec;62(12):2339-2344.
Alpern JD, Stauffer WM, Kesselheim AS. High-cost generic drugs–implications for patients and policymakers. N Engl J Med. 2014 Nov 13;371(20):1859-62.
Baird LG, Banken R, Eichler HG, Kristensen FB, Lee DK, Lim JC, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, Hirsch G. Accelerated access to innovative medicines for patients in need. Clin Pharmacol Ther. 2014 Nov;96(5):559-71.
Becker JE, Ross JS. Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications. Ann Intern Med. 2014 Nov 18;161(10):760.
Gagne JJ, Thompson L, O'Keefe K, Kesselheim AS. Innovative research methods for studying treatments for rare diseases: methodological review. BMJ. 2014 Nov 24;349:g6802.
Manz C, Ross JS, Grande D. Marketing to physicians in a digital world. N Engl J Med. 2014 Nov 13;371(20):1857-9.
Patel MS, Day S, Small DS, Howell JT 3rd, Lautenbach GL, Nierman EH, Volpp KG. Using Default Options Within the Electronic Health Record to Increase the Prescribing of Generic-Equivalent Medications: A Quasi-experimental Study. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S44-52.
Reynolds IS, Rising JP, Coukell AJ, Paulson KH, Redberg RF. Assessing the Safety and Effectiveness of Devices After US Food and Drug Administration Approval: FDA-Mandated Postapproval Studies. JAMA Intern Med. 2014 Nov 1;174(11):1773-9.
Woloshin S, Schwartz LM, Frankel B, Faerber A. US Food and Drug Administration and design of drug approval studies. JAMA. 2014 Nov 26;312(20):2163-5.
Chambers JD, Thorat T, Pyo J, Chenoweth M, Neumann PJ. Despite high costs, specialty drugs may offer value for money comparable to that of traditional drugs. Health Aff (Millwood). 2014 Oct 1;33(10):1751-60.
Dunn AG, Arachi D, Hudgins J, Tsafnat G, Coiera E, Bourgeois FT. Financial conflicts of interest and conclusions about neuraminidase inhibitors for influenza: an analysis of systematic reviews. Ann Intern Med. 2014 Oct 7;161(7):513-8.
Kesselheim AS, Tan YT, Darrow JJ, Avorn J. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Aff (Millwood). 2014 Oct 1;33(10):1770-8.
Miladinovic B, Kumar A, Mhaskar R, Djulbegovic B. Benchmarks for detecting 'breakthroughs' in clinical trials: empirical assessment of the probability of large treatment effects using kernel density estimation. BMJ Open. 2014 Oct 21;4(10):e005249.
Naci H, Alexander GC. Regulators should better leverage effectiveness standards to enhance drug value. Pharmacotherapy. 2014 Oct;34(10):1005-11.
Sarpatwari A, Kesselheim AS, Malin BA, Gagne JJ, Schneeweiss S. Ensuring patient privacy in data sharing for postapproval research. N Engl J Med. 2014 Oct 23;371(17):1644-9.
Starner CI, Alexander GC, Bowen K, Qiu Y, Wickersham PJ, Gleason PP. Specialty drug coupons lower out-of-pocket costs and may improve adherence at the risk of increasing premiums. Health Aff (Millwood). 2014 Oct 1;33(10):1761-9.
Woodcock J. Paving the critical path of drug development: the CDER perspective. Nat Rev Drug Discov. 2014 Oct 31;13(11):783-4.
Yeh JS, Austad KE, Franklin JM, Chimonas S, Campbell EG, Avorn J, Kesselheim AS. Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study. PLoS Med. 2014 Oct 14;11(10):e1001743.
Avorn J. Rethinking the use of physicians as hired expert lecturers. Ann Intern Med. 2014 Sep 2;161(5):363-364.
Brennan TA, Wilson JM. The special case of gene therapy pricing. Nat Biotechnol. 2014 Sep 9;32(9):874-876.
Checchi KD, Huybrechts KF, Avorn J, Kesselheim AS. Electronic medication packaging devices and medication adherence: a systematic review. JAMA. 2014 Sep 24;312(12):1237-1247.
Floyd JS, Psaty BM. The potential risks of expedited approval of drugs for acute bacterial infections. JAMA Intern Med. 2014 Sep 1;174(9):1436-1437.
Gagne JJ, Choudhry NK, Kesselheim AS, Polinski JM, Hutchins D, Matlin OS, Brennan TA, Avorn J, Shrank WH. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014 Sep 16;161(6):400-407.
Haffajee R, Parmet WE, Mello MM. What is a public health "emergency"? N Engl J Med. 2014 Sep 11;371(11):986-988.
Joffe S, Miller FG. Ethics of cancer clinical trials in low-resource settings. J Clin Oncol. 2014 Sep 2 [Epub ahead of print].
Krumholz HM, Peterson ED. Open access to clinical trials data. JAMA. 2014 Sep 10;312(10):1002-1003.
Redberg RF. Sham controls in medical device trials. N Engl J Med. 2014 Sep 4;371(10):892-893.
Ross JS, Frazee SG, Garavaglia SB, Levin R, Noyshadian H, Jackevicius CA, Stettin G, Krumholz HM. Trends in Use of Ezetimibe After the ENHANCE Trial, 2007 Through 2010. JAMA Intern Med. 2014 Sep 1;174(9):1486-1493.
Brodersen J, Schwartz LM, Woloshin S. Overdiagnosis: how cancer screening can turn indolent pathology into illness. APMIS. 2014 Aug;122(8):683-689.
Duke JD, Kesselheim AS. The Food and Drug Administration's Role in Promoting Consistent Labels for Generic Drugs. JAMA Intern Med. 2014 Aug 1;174(8):1213-1214.
Evans SJ, Leufkens HG. Regulatory decision-making: are we getting it right? Pharmacoepidemiol Drug Saf. 2014 Aug 11 [Epub ahead of print].
Frank C, Himmelstein DU, Woolhandler S, Bor DH, Wolfe SM, Heymann O, Zallman L, Lasser KE. Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals. Health Aff (Millwood). 2014 Aug 1;33(8):1453-1459.
Harrison C. Software patent ruling gives pointers for diagnostics. Nat Rev Drug Discov. 2014 Aug 1;13(8):569.
Hess CN, Roe MT, Gibson CM, J Temple R, Pencina MJ, Zarin DA, Anstrom KJ, Alexander JH, Sherman RE, Fiedorek FT, Mahaffey KW, Lee KL, Chow SC, Armstrong PW, Califf RM. Independent data monitoring committees: preparing a path for the future. Am Heart J. 2014 Aug;168(2):135-141.e1.
Hwang TJ, Bourgeois FT. New Regulatory Paradigms for Innovative Drugs to Treat Pediatric Diseases. JAMA Pediatr. 2014 Aug 11 [Epub ahead of print].
Naci H, Ioannidis JP. How Good Is "Evidence" from Clinical Studies of Drug Effects and Why Might Such Evidence Fail in the Prediction of the Clinical Utility of Drugs? Annu Rev Pharmacol Toxicol. 2014 Aug 21 [Epub ahead of print].
Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness–the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371(9):796-797.
Ross JS. It's Not Just About the Money, Money, Money… JAMA Intern Med. 2014 Aug 25 [Epub ahead of print].
Ross JS. Randomized Clinical Trials and Observational Studies Are More Often Alike Than Unlike. JAMA Intern Med. 2014 Aug 11 [Epub ahead of print].
White C. NICE confirms advanced breast cancer drug is too expensive for NHS. BMJ. 2014 Aug 7;349:g5078.
Wolfe SM. Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products: A Misguided Approach. JAMA Intern Med. 2014 Aug 15 [Epub ahead of print].
Austad KE, Avorn J, Franklin JM, Campbell EG, Kesselheim AS. Association of marketing interactions with medical trainees' knowledge about evidence-based prescribing: results from a national survey. JAMA Intern Med. 2014 Aug 1;174(8):1283-1290.


Professional HTML Coder,Graphic Designer and Web Developer with 5 years of progressive experience. I have developed and designed user friendly websites and have handled complete email marketing campaigns which includes designing and coding of email templates. Skills: * MailChimp Editable Email Template * HTML Email Newsletter Design * PSD to HTML. * Mailchimp Responsive Email Template Design & development. * Email & Draft/proofing * Code Custom email newsletter templates * PSD, PDF, JPG to HTML Email Template * Develop Custom email newsletter for email marketing tools like: Mailchimp, Constant Contact, Aweber, Constant Contact. * Set up emailcampaign different email platforms (Mailchimp, Constant Contact, Aweber, Campaign monitor,GR ). * Reduce spam complaints and opt-outs. * Auto-responders and automated follow-up campaigns to keep your audience engaged; * Manage Mailing Lists and design segmentation like clickers, openers buyers as per action on email of the customers.
Worked as Email Marketing Manager in which I used to handled complete bulk email marketing (creating up the emails and sending out to customer from the email platform).


BEAR LAKE is located in MANISTEE county, Michigan at latitude 44.421813 and longitude -86.146860. The population of BEAR LAKE is 331 as of the year 2005 with a population growth of 4.09% from the year 2000 through 2005. The most common zip code of BEAR LAKE is 49614.


At the 2014 Strata + Hadoop conference John Rauser gave a great keynote title "Statistics Without the Agonizing Pain". It is probably worth watching before reading the rest of this article, in it he introduces the concept of Random Permutation Tests.
"Classic" statistical tests usually make some sort of assumption about the distribution of the data e.g. normally distribution data . Are these assumptions always true? Probably not, but they are often approximately close enough to give you a useful result. By making these assumptions, these tests are called parametric.
Your data just doesn't seem to fit the distribution the classic statistical test assumes. For instance, perhaps it is bi-modal and the test assumes normality.
You have outliers e.g. users who spend significantly more than others.
You have a small sample size.
Compute a test statistic between two (or more) groups. This could be the difference between two proportions, the difference between the means of the two groups etc.
Now randomly shuffle the data assigned to each group.
Measure the test statistic again on the shuffled data.
Look at where the test statistic from 1 falls in the distribution of test statistics from 2-4.
We have used steps 2-4 to empirically estimate the sampling distribution of the test statistic. From this distribution you can compute the p-value for your observed test statistic.
Let's imagine we want to add a new widget on our checkout page of our e-commerce site to upsell products to a user.
The question we want to answer is, does adding the widget increase our revenue?
We know how much each user spent and what variant they have been given.
We have randomly sampled the data from a log-normal distribution with equal mean and variance. We set the seed to ensure the results are repeatable. So in this case, we are looking to find there is no significant difference between the two datasets.
The classic statistical approach here would be to use a t-test. Let's instead apply our random permutation test.
This gives a difference of 193.47. How likely is this to have happened by chance?
On the two-tailed test, we get a p-value of 0.102, so we would accept the null hypothesis of there being no difference. Notice the add one here on both the denominator and numerator. Essentially we are adding our original measured test statistic to the random permutations. This ensures we never get a zero probability.
The standard t-test would give a p-value of 0.0985, so roughly similar. However, what if we didn't care about the mean, but the median transaction value? Using random permutation tests, this is very simple to compute (a simple change to our code). Under classic statistical tests, we would have to go off and find the exact test we need to use under those conditions.
Generally you will find this is much faster for running large numbers of iterations.
Random permutation tests are a nice alternative to classic hypothesis tests. In many cases they will give you almost exactly the same results. Being able to visualise the distribution (Figure 2) can be a massive assistance in explaining the p-value.
Can be used for any test statistic (either it is implemented in coin or can be programmed yourself).
Can be applied to all sorts of data types (numerical, ordinal, categorical) without having to remember the exact parametric test you should use.
Relies on the null hypothesis, that there is no association between the dataset and so the group labels are interchangeable under the null hypothesis.
Personally, I like to use both classic statistical tests and random permutation tests, even if all they do is validate one another.
Thank you, this has been very helpful.


text:
A non-convergent discourse (NCD) is a discourse in which the participants do not converge in their language, which results in the use of different languages. Alternative names for this phenomenon are asymmetric and bilingual discourse.

The term was introduced by the sociologist Reitze Jonkman. He distinguishes two motivations for people to engage in an NCD:

Insufficient active knowledge of the other participants' language, combined with a good passive knowledge. It usually takes longer for a person learning a foreign language to speak it fluently than to understand it when it is being spoken. This type of NCD is common in the Germanic languages of the Scandinavian-Nordic region of Europe, where the differences between Swedish, Norwegian, and Danish are relatively small, and do not necessarily obstruct use of the participants' native languages. The same occurs between speakers of Dutch and Afrikaans and to a lesser degree between speakers of Italian and Spanish, Portuguese and Spanish (and their respective variants), where it is also possible to understand what the other person is saying as long as it is said slowly; (as such between residents of Spain and Portugal as well as between residents of Brazil and neighboring Spanish-speaking countries). Also, it is possible among speakers of various South-Slavic languages. For instance, a Serbian tourist in Macedonia or Bulgaria will often be able to communicate with locals without ever having studied Bulgarian or Macedonian. Another good example would be north India - Users of Hindi, Urdu, Punjabi, Gujrati understand each other very well while speaking their mother tongue. In East India, Bengali and Assamese speakers can usually understand one another's speech. Also in South India, Tamil and Malayalam Speakers are often able to understand each other and converse in their native languages to each other while understanding the bulk of the conversation.  In some areas where bilingualism is common, this can also be done with languages that are not mutually intelligible if both speakers are assumed to understand the other's language, as is the case in cities like Montreal.
Ethnic marking: the use of a preferred variety, in order to stress one's belonging to a certain cultural or ethnic group. This occurs in Northern Germany, for example, where speakers of Low German and standard German do not converge.

A third motivation for engaging in an NCD lies on the personal level. According to Giles' Communication Accommodation Theory, interpersonal contacts are negotiations. In a discourse, people seek to create understanding by stressing common features. However, when this will for creating understanding is not present (for example, in cases where the participants feel a strong dislike for each other), they dissociate from each other by stressing the differences. The use of different languages might be the result of such a dissociation strategy.

Sometimes the motivation for engaging in an NCD is misunderstood, especially in contexts where they are uncommon. NCD participants with an ethnic marking strategy might be wrongly interpreted as if they were expressing dislike. This type of misunderstanding is especially common among speakers who come from monolingual areas and find themselves in a bilingual area, where a second language is used alongside their own and NCDs are common.

See also
Mutual intelligibility

References

Sociolinguistics
Multilingualism
Bilingualism

redpajama_set_name: RedPajamaWikipedia


Plenty of plum lead on a palate that adds brown sugar and vanilla. Drink with burgers. Recommended. 86 points.
This is fruit-forward, complex, and pillow soft. Drink with pork medallions with mushrooms. Recommended. 89 points.


Home / 4 Aranmore house, Custom House Harbour, IFSC, Dublin 1.
4 Aranmore house, Custom House Harbour, IFSC, Dublin 1.
Owen Reilly 4 Aranmore house, Custom House Harbour, IFSC, Dublin 1.
South facing two bedroom apartment with water views situated on the ground floor and located in the heart of the thriving Dublin Docklands. Features include a designated parking space, two bathrooms and a spacious interior. Custom House Harbour is a modern, well managed development in a prime location next door to a Luas Stop & Connolly Station and just minutes from the recently announced location of the new Salesforce office. The accommodation briefly comprises a welcoming entrance hall, open plan living room, kitchen with access to a south facing terrace, two double bedrooms, master en-suite and a bathroom. This property will suit both owner occupiers and investors.
Ideally situated in the heart of Dublin's financial district with a range of bars, bistros, cafes, restaurants, the Gibson & Spencer Hotels and the National College of Ireland literally on the doorstep while the iconic Samuel Beckett Bridge allows a ten minute walk to Grand Canal Dock and all the amenities it has to offer. There are a wide variety of gyms, fitness centres and sports clubs close by. The LUAS stop at the gates of the development at Mayor Square provides easy access to the rest of the city and beyond. PWC, AIG and Facebook are just some of the major employers in the area.
Welcoming entrance hall with timber flooring and hot press.
Generous, south facing living room with water views from large terrace (3.63m x 1.36m).
Fully equipped kitchen to include electric hob, oven and extractor fan, with fridge freezer and washing machine.
Large double room with built in wardrobes and timber flooring.
With shower, WC, WHB, shelving and extractor fan.
Double room with built in wardrobe.
With WC, WHB, shower & bath.


I am based in budapest and as well available in europe and worldwide travel !. YOU CAN CALL ME ANY TIME.
Hot in Copiapo who can do For family couples, are only on INSTITUTFRANCAIS-DUESSELDORF.EU. To invite baby is very simple. Just send her an SMS. Today in this region the best girl - Feast. The first and most obvious victims of the government's lies are the 40,000 or Prostitute in Copiapo Americans who this year will become HIV-positive, covered in Cassie's blood and fluid. Why, after so much time and money, are so many still dying. "As long as this was seen as a gay disease.