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.
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- 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.
- Fralick M, Kesselheim AS. FDA Approval of Desmopressin for Nocturia. JAMA. 2017 Apr 6. [Epub ahead of print]
- 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.
- Sharfstein J. Déjà Vu at the FDA. Milbank Q. 2017 Apr 4. [Epub ahead of print]
- Bouvy JC, Blake K, Slattery J, De Bruin ML, Arlett P, Kurz X. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013. Pharmacoepidemiol Drug Saf. 2017 Mar 26. [Epub ahead of print]
- 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.
- Luo J, Kesselheim AS, Avorn J. Medicaid Expenditures and Estimated Rebates for Epinephrine Autoinjectors, 2012 to 2016. JAMA Intern Med. 2017 Mar 27. [Epub ahead of print]
- Prasad V, Jesus K, Mailankody S. The high price of anticancer drugs: origins, implications, barriers, solutions. Nat Rev Clin Oncol. 2017 Mar 14. [Epub ahead of print]
- Choudhry NK, Krumme AA, Ercole PM, Girdish C, Tong AY, Khan NF, Brennan TA, Matlin OS, Shrank WH, Franklin JM. Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 27. [Epub ahead of print]
- Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS. Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence. Drugs. 2017 Feb 8. [Epub ahead of print]
- 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.
- Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033. [Epub ahead of print]
- 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.
- Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat Rev Drug Discov. 2017 Feb 24. [Epub ahead of print]
- 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.
- Califf RM. Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance. JAMA. 2017 Jan 20. [Epub ahead of print]
- Hakim A, Ross JS. High Prices for Drugs With Generic Alternatives: The Curious Case of Duexis. JAMA Intern Med. 2017 Jan 23. [Epub ahead of print]
- Kesselheim AS, Rome BN, Sarpatwari A, Avorn J. Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers. Health Aff (Millwood). 2017 Jan 18. [Epub ahead of print]
- 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.
- Rose SL, Highland J, Karafa MT, Joffe S. Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest. JAMA Intern Med. 2017 Jan 17. [Epub ahead of print]
- Saavedra K, O’Connor B, Fugh-Berman A. Pharmacist-industry relationships. Int J Pharm Pract. 2017 Jan 18. [Epub ahead of print]
- 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.
- Bauer SR, Redberg RF. Improving the Accelerated Pathway to Cancer Drug Approvals. JAMA Intern Med. 2016 Nov. [Epub ahead of print]
- Califf RM, Sherman RE, Slavitt A. Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS. JAMA. 2016 Nov 29. [Epub ahead of print]
- Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016 Nov 2. [Epub ahead of print]
- Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS. Active Surveillance of Follow-on Biologics: A Prescription for Uptake. Drug Saf. 2016 Nov 12. [Epub ahead of print]
- 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.
- Dafny LS, Ody CJ, Schmitt MA. Undermining Value-Based Purchasing – Lessons from the Pharmaceutical Industry. N Engl J Med. 2016 Oct. [Epub ahead of print]
- Doshi P. Is this trial misreported? Truth seeking in the burgeoning age of trial transparency. 2016;355:i5543.
- Hwang TJ, Carpenter D, Lauffenburger JC, Wang B, Franklin JM, Kesselheim AS. Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results. JAMA Intern Med. 2016 Oct. [Epub ahead of print]
- Kesselheim AS, Avorn J. Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy. 2016 Oct. [Epub ahead of print]
- 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.
- Tominaga T, Miyazaki S, Oniyama Y, Weber AD, Kondo T. The Japanese Postmarketing Adverse Event Relief System: A confluence of regulatory science, the legal system, and clinical pharmacology. Clin Pharmacol Ther. 2016 Oct. [Epub ahead of print]
- Wang C, Kane R, Levenson M, Kelman J, Wernecke M, Lee JY, Kozlowski S, Dekmezian C, Zhang Z, Thompson A, Smith K, Wu YT, Wei Y, Chillarige Y, Ryan Q, Worrall C, MaCurdy TE, Graham DJ. Association Between Changes in CMS Reimbursement Policy and Drug Labels for Erythrocyte-Stimulating Agents With Outcomes for Older Patients Undergoing Hemodialysis Covered by Fee-for-Service Medicare. JAMA Intern Med. 2016 Oct. [Epub ahead of print]
- 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.
- Kister I, Corboy JR.Reducing costs while enhancing quality of care in MS. Neurology. 2016 Sep 2. [Epub ahead of print]
- 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.
- Lin D, Lucas E, Murimi IB, Jackson K, Baier M, Frattaroli S, Gielen A, Moyo P, Simoni-Wastilla L, Alexander GC. Physician attitudes and experiences with Maryland’s prescription drug monitoring program (PDMP). Addiction. 2016. [Epub ahead of print]
- 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 Pharamcol Ther. 2016. [Epub ahead of print]
- 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.
- 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. [Epub ahead of print]
- 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.
- Green AK, Wood WA, Basch EM. Time to Reassess the Cancer Compendia for Off-label Drug Coverage in Oncology. JAMA. 2016 Aug. [Epub ahead of print]
- 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.
- 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 Aug. [Epub ahead of print]
- 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.
- Gellad WF, Good CB. Prescription of Brand-Name Medications When Generic Alternatives Are Available-Patently Unfair. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
- 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.
- Ioannidis JP. Why Most Clinical Research Is Not Useful. PLoS Med. 2016;13(6):e1002049.
- 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.
- Luo J, Seeger JD, Donneyong M, Gagne JJ, Avorn J, Kesselheim AS. Effect of Generic Competition on Atorvastatin Prescribing and Patients’ Out-of-Pocket Spending. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
- 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.
- Quesada O, Yang E, Redberg RF. Availability and Dissemination of Results From US Food and Drug Administration-Mandated Postapproval Studies for Medical Devices. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
- 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.
- Schwartz LM, Woloshin S, Zheng E, Tse T, Zarin DA. ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials. Ann Intern Med. 2016 Jun 14. [Epub ahead of print]
- Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015. Ann Intern Med. 2016 May 31. [Epub ahead of print]
- 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.
- Hey SP, Weijer C. What questions can a placebo answer? Monash Bioeth Rev. 2016 May 17. [Epub ahead of print]
- Kapczynski A, Kesselheim AS. ‘Government Patent Use’: A Legal Approach To Reducing Drug Spending. Health Aff. 2016 May 1;35(5):791-7.
- Kim C, Prasad V. Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration’s Approval of Oncology Drugs. Mayo Clin Proc. 2016 May 10. [Epub ahead of print]
- 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.
- Patel MS, Day SC, Halpern SD, Hanson CW, Martinez JR, Honeywell S Jr, Volpp KG. Generic Medication Prescription Rates After Health System-Wide Redesign of Default Options Within the Electronic Health Record. JAMA Intern Med. 2016 May 9. [Epub ahead of print]
- Yeh JS, Franklin JM, Avorn J, Landon J, Kesselheim AS. Association of Industry Payments to Physicians With the Prescribing of Brand-name Statins in Massachusetts. JAMA Intern Med. 2016 May 9. [Epub ahead of print]
- 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.
- Qato DM, Wilder J, Schumm LP, Gillet V, Alexander GC. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011. JAMA Intern Med. 2016 Mar 21. [Epub ahead of print]
- Yeh JS, Sarpatwari A, Kesselheim AS. Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels. Drug Saf. 2016 Mar 21. [Epub ahead of print]
- 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.
- 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 Feb 16. [Epub ahead of print]
- 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.
- 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 Feb 10. [Epub ahead of print]
- Phillips AT, Rathi VK, Ross JS. Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study. JAMA Intern Med. 2016 Feb 22. [Epub ahead of print]
- 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. In Opposition to Liberty: We Need a “Sovereign” to Govern Drug Claims. Ann Intern Med. 2015 June 30. [Epub ahead of print]
- 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.
- Kapczynski, A. (2015). The Trans-Pacific Partnership – Is It Bad for Your Health? N Engl J Med.2015 June 10. [Epub ahead of print]
- 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.
- McMahon AW, Wharton GT, Bonnel R, et al. Pediatric post-marketing safety systems in North America: assessment of the current status. Pharmacoepidemiol Drug Saf. 2015 June 22. [Epub ahead of print]
- 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.
- Jena AB, Ho O, Goldman DP, Karaca-Mandic P. The Impact of the US Food and Drug Administration Chlorofluorocarbon Ban on Out-of-pocket Costs and Use of Albuterol Inhalers Among Individuals With Asthma. JAMA Intern Medicine. 2015 May 11. [Epub ahead of print]
- 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.
- Sarpatwari A, Avorn J, Kesselheim AS. Progress and Hurdles for Follow-on Biologics. N Engl J Med. 2015 May 6. [Epub ahead of print]
- Cho MK, Magnus D, Constantine M, Lee SS, Kelley M, Alessi S, Korngiebel D, James C, Kuwana E, Gallagher TH, Diekema D, Capron AM, Joffe S, Wilfond BS. Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Ann Intern Med. 2015 Apr 14. [Epub ahead of print]
- Daubresse M, Hutfless S, Kim Y, Kornfield R, Qato DM, Huang J, Miller K, Emery SL, Alexander GC. Effect of Direct-to-Consumer Advertising on Asthma Medication Sales and Healthcare Utilization. Am J Respir Crit Care Med. 2015 Apr 16. [Epub ahead of print]
- Goldacre B. How to get all trials reported: audit, better data, and individual accountability. PLoS Med. 2015 Apr 14;12(4):e1001821.
- Kesselheim AS, Franklin JM, Kim SC, Seeger JD, Solomon DH. Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population. J Gen Intern Med. 2015 Apr 9. [Epub ahead of print]
- 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.
- Kesselheim AS, Polinski JM, Fulchino LA, Isaman DL, Gagne JJ. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes. Drugs. 2015 Mar 31. [Epub ahead of print]
- Knox C, Hampp C, Willy M, Winterstein AG, Pan GD. Patient understanding of drug risks: an evaluation of medication guide assessments. Pharmacoepidemiol Drug Saf. 2015 Mar 23. [Epub ahead of print]
- 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.
- Seife C. Research misconduct identified by the US Food and Drug Administration: Out of sight, out of mind, out of the peer-reviewed literature. JAMA Intern Med. 2015 Feb 9. [Epub ahead of print]
- Wang B, Liu J, Kesselheim AS. Variations in Time of Market Exclusivity Among Top-Selling Prescription Drugs in the United States. JAMA Intern Med. 2015 Feb 9. [Epub ahead of print]
- 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.
- Sharfstein J. FDA Regulation of Laboratory-Developed Diagnostic Tests: Protect the Public, Advance the Science. JAMA. 2015 Jan 5. [Epub ahead of print]
- 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.
- Kesselheim AS, Huybrechts KF, Choudhry NK, Fulchino LA, Isaman DL, Kowal MK, Brennan TA. Prescription Drug Insurance Coverage and Patient Health Outcomes: A Systematic Review. Am J Public Health. 2014 Dec 18:e1-e14. [Epub ahead of print]
- Nissen SE. Commentary: Confidentiality of interim trial data-The emerging crisis. Clin Trials. 2014 Dec 18. [Epub ahead of print]
- 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.
- Riggs KR, Buttorff C, Alexander GC. Impact of Out-of-Pocket Spending Caps on Financial Burden of those with Group Health Insurance. J Gen Intern Med. 2014 Dec 4. [Epub ahead of print]
- Zarin DA, Tse T, Sheehan J. The Proposed Rule for U.S. Clinical Trial Registration and Results Submission.N Engl J Med. 2014 Dec 24. [Epub ahead of print]
- 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.
- Lexchin J. Postmarket safety warnings for drugs approved in Canada under the Notice ofCompliance with conditions policy. Br J Clin Pharmacol. 2014 Nov 12. [Epub ahead of print]
- 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.
- Vermeer NS, Spierings I, Mantel-Teeuwisse AK, Straus SM, Giezen TJ, Leufkens HG, Egberts TC, De Bruin ML. Traceability of biologicals: present challenges in pharmacovigilance. Expert Opin Drug Saf. 2014 Nov 5:1-10. [Epub ahead of print]
- 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.
- Chang CQ, Tingle SR, Filipski KK, Khoury MJ, Lam TK, Schully SD, Ioannidis JP. An overview of recommendations and translational milestones for genomic tests in cancer. Genet Med. 2014 Oct 23. [Epub ahead of print]
- 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.
- Wang B, Canestaro WJ, Choudhry NK.Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in US Food and Drug Administration Drug Labels. JAMA Intern Med. 2014 Oct 13. [Epub ahead of print]
- 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.
- Daubresse M, Alexander GC. The uphill battle facing anti-obesity drugs. Int J Obes (Lond). 2014 Sep 12. [Epub ahead of print]
- Evans BJ, Dorschner MO, Burke W, Jarvik GP. Regulatory changes raise troubling questions for genomic testing. Genet Med. 2014 Sep 25. [Epub ahead of print]
- 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. Evaluating Novel Therapies During the Ebola Epidemic. JAMA. 2014 Sep 11. [Epub ahead of print]
- 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.
- Vermeer NS, Duijnhoven RG, Straus SM, Mantel-Teeuwisse AK, Arlett PR, Egberts AC, Leufkens HG, De Bruin ML. Risk management plans as tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe. Clin Pharmacol Ther. 2014 Sep 15. [Epub ahead of print]
- 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.