Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from the characteristics of expanded access programs, to the association of the priority review voucher with neglected tropical disease drug and vaccine development, to the use of surrogate outcomes in oncology. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bonnie RJ, Kesselheim AS, Clark DJ. Both Urgency and Balance Needed in Addressing Opioid Epidemic: A Report from the National Academies of Sciences, Engineering, and Medicine. 2017 Jul 13. [E-pub ahead of print]
  2. Fralick M, Avorn J, Kesselheim AS. The Price of Crossing the Border for Medications. N Engl J Med. 2017;377(4):311-313.
  3. Hwang TJ, Kesselheim AS, Sarpatwari A. Value-Based Pricing and State Reform of Prescription Drug Costs. 2017 Jul 10. [E-pub ahead of print]
  4. Jain N, Hwang TJ, Franklin JM, Kesselheim AS. Association of the Priority Review Voucher with Neglected Tropical Disease Drug and Vaccine Development. 2017;318(4):388-389.
  5. 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;15(1):134.
  6. Miller JE, Ross JS, Moch KI, Caplan AL. Characterizing Expanded Access and Compassionate Use Programs for Experimental Drugs. BMC Res Notes. 2017;10(1):350.
  7. 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. 2017;18(1):333.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of May. The selections feature topics ranging from post-approval safety events among novel drugs approved between 2001 and 2010, to the failure of the Alzheimer’s drug Solanezumab, to the three-year impacts of the Affordable Care Act among low-income adults. A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. Gellad WF, Kesselheim AS. Accelerated approval and expensive drugs – a challenging combination. N Engl J Med. 2017 May 25;376(21):2001-2004.
  3. 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.
  4. 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.
  5. 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.

PFC Spotlight Series: Faculty Affiliate Ameet Sarpatwari

Learn more about the Petrie-Flom Center’s work through our Spotlight Series, which features interviews with Student and Academic Fellow alumni, as well as current Faculty Affiliates.

sarpatwari_peopleThis week’s post features Ameet Sarpatwari, J.D., Ph.D., who is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL). His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

Read the article to learn more about his contributions to the Center and its mission!

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of March. The selections feature topics ranging from the characteristics and follow-up of post-marketing studies or conditionally authorized medicines in the European Union; to changes in prescription drug, over the counter drug, and dietary supplement use among older adults in the United States; to an assessment of the logic of Amarin’s off-label promotion of Vascepa. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Hey SP, Kesselheim AS. An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion. PLoS Med. 2016 Mar 15;13(3):e1001978.
  2. 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].
  3. Kapczynski A. Free Speech and Pharmaceutical Regulation-Fishy Business. JAMA Intern Med. 2016 Mar 1;176(3):295-6.
  4. 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.
  5. 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]
  6. 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]

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of August. The selections feature topics ranging from the impact of Florida’s pill mill and prescription drug monitoring program laws on opioid prescribing and use, to the FDA’s revised guidance on direct-to-consumer marketing, to trends in Medicaid reimbursement for insulin products.  A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. Djulbegovic B. Value-Based Cancer Care and the Excessive Cost of Drugs. JAMA Oncol. 2015 Aug 27. [Epub ahead of print].
  3. 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].
  4. 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].
  5. Luo J, Kesselheim AS. The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines. JAMA. 2015 Aug 20. [Epub ahead of print].
  6. 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.
  7. Robertson CT. New DTCA Guidance – Enough to Empower Consumers? N Engl J Med. 2015 Aug 19. [Epub ahead of print].
  8. 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].
  9. 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].

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of March.  The selections feature topics ranging from the reporting compliance of trial results to ClinicalTrials.gov, to the impact of risk evaluation and mitigation strategy-mandated medication guides on patient knowledge, to the cost-effectiveness of the novel hepatitis C virus medications.  A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. 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.
  3. 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.
  4. 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]
  5. 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]
  6. 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.
  7. 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.
  8. 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.
  9. 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.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of February.  The selections feature topics ranging from an underreporting of deviations from good clinical practice in peer-reviewed medical journals, to the impact of risk evaluation and mitigation strategies on off-label prescribing, to repairing the broken market for antibiotic innovation.  A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Rising JP, Moscovitch B. Characteristics of pivotal trials and FDA review of innovative devices. PLoS One. 2015 Feb 4;10(2):e0117235.
  7. 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.
  8. 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]

  9. 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]
  10. 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.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of January.  The selections feature topics ranging from the trend in lag-time between FDA approval of drugs and published cost-utility evidence; to practical, legal, and ethical issues with expanded access to investigational drugs; to the use of tiered formularies to discriminate against patients with HIV in the federal marketplace.  A full posting of abstracts/summaries of these articles may be found on our website.

  1. Aliferis L. Variation in prices for various medical tests and procedures. JAMA Intern Med. 2015 Jan 1;175(1):11-12.
  2. 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.
  3. 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.
  4. Drazen JM. Sharing individual patient data from clinical trials. New Eng J Med. 2015 Jan 15;372(3):201-202.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. Sharfstein J. FDA Regulation of Laboratory-Developed Diagnostic Tests: Protect the Public, Advance the Science. JAMA. 2015 Jan 5. [Epub ahead of print]

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital/Harvard Medical School reviews the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from December. The selections feature topics ranging from access to clinical trials data, to pharmacy-based interventions to reduce primary medication non-adherence, to the impact of out-of-pocket spending caps on the non-elderly with private group health insurance. A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. 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.
  3. 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]

  4. Nissen SE. Commentary: Confidentiality of interim trial data-The emerging crisis. Clin Trials. 2014 Dec 18. [Epub ahead of print]

  5. 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.

  6. 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]

  7. 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]

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital/Harvard Medical School reviews the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from November. The selections feature topics ranging from the use of e-prescribing defaults to promote physician prescribing of generic drugs, to the characteristics of post-approval studies of medical devices ordered by the FDA, to a comparison of existing and emerging accelerated access pathways in the United States, European Union, Canada, and Singapore. A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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]
  6. Manz C, Ross JS, Grande D. Marketing to physicians in a digital world. N Engl J Med. 2014 Nov 13;371(20):1857-9.
  7. 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.
  8. 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.
  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]
  10. 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.

New BoH Feature: Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital/Harvard Medical School reviews the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.  We are thrilled to announce that PORTAL (specifically Aaron Kesselheim and Ameet Sarpatwari) will being posting these curated round-ups at Bill of Health each month, with a full posting including abstracts/summaries at their website.

Below are the abstracts/summaries for papers identified from October.  The selections feature topics ranging from the cost-utility of specialty drugs, to the association between financial conflicts of interest and favorable assessments of newer influenza treatments, to the clinical evidence supporting biomarker testing reported in FDA drug labels.  We thank Lara Maggs and Nazleen Khan for their contributions to this review.

  1. 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.
  2. 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]
  3. 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.
  4. 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.
  5. 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.
  6. Naci H, Alexander GC. Regulators should better leverage effectiveness standards to enhance drug value. Pharmacotherapy. 2014 Oct;34(10):1005-11.
  7. 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.
  8. 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.
  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]
  10. Woodcock J. Paving the critical path of drug development: the CDER perspective. Nat Rev Drug Discov. 2014 Oct 31;13(11):783-4.
  11. 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.