E D I T O R IA L S
diseases, and promote healthy families. All health professionals know that in those with chronic and severe illness, care almost always relies in part on family. And when things get really dif ficult, as when life and death decisions need to be made, physicians know that talking with a patient’s partner is not legally the same as working with a patient’s spouse. Many same-sex couples are now raising children, and the health of those children demands that their parents have the full rights and protection o f marriage. In our society, marriage is often essential to ob taining and keeping adequate health insurance coverage for both members of a couple and for their children. More than 1000 federal benefits are conferred by marriage, among them access to family medical leave, Medicaid, and Veterans Affairs medical services. Some o f those bene fits, however, are in jeopardy for same-sex spouses in states that do not recognize their union. The current situation — with same-sex
marriages, including those in families with children, legally recognized in some states but not others — makes no sense, and the harmful consequences for health are well documented. The Supreme Court should require the full recognition of same-sex marriage throughout this country. If the Court rules otherwise, what ever the legal logic, a clear injustice will result. And that injustice would damage the health and welfare of millions o f Americans. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. T h is a r tic le w a s p u b lis h e d o n A p r il
22, 2015,
a t N E J M .o rg .
1. Bayer R. Homosexuality and American psychiatry: the poli tics of diagnosis. Princeton, NJ: Princeton University Press, 1987. 2. Monette P. Becoming a man: half a life story. New York: HarperCollins, 1992. 3. Gonzales G. Same-sex marriage — a prescription for better health. N Engl J Med 2014;370:1373-6. D O I: 10.1056/N E jM el505179 Copyright © 2015 Massachusetts Medical Society.
R evisiting th e C o m m e rc ia l-A c a d e m ic In terface Jeffrey M. Drazen, M.D.
In the mid-1940s, Selman Waksman, a soil micro biologist, and his team discovered streptomycin, an antibiotic with action against the tubercle bacillus.1 Although he was able to show efficacy in the laboratory, Waksman realized that if his discovery was to be of value to the world, he needed a partner capable o f manufacturing ade quate amounts o f the material under conditions that would make it suitable for use in humans. He therefore struck a deal with Merck to pro duce streptomycin for clinical use.1 Soon there after, the British Medical Association undertook a large randomized, controlled trial of strepto mycin for the treatment of tuberculosis. The re sults, including a description of the utility of streptomycin and resistance to it, were pub lished in the British Medical Journal.2 This partner ship between an academic researcher and a drug company went on to alleviate substantial human suffering and should be a model for current be havior. Unfortunately, it is not. In 1950, Waksman, who was arguably the
N
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world’s leading authority on antibiotic treatment of tuberculosis and who 2 years later received the Nobel Prize in Physiology or Medicine, was the sole author of a review article on streptomy cin and neomycin published in the British Medical Journal.3 That would most likely not happen to day. Over the past two decades, largely because of a few widely publicized episodes of unaccept able behavior by the pharmaceutical and bio technology industry, many medical journal edi tors (including me) have made it harder and harder for people who have received industry payments or items of financial value to write editorials or review articles.4 The concern has been that such people have been bought by the drug companies. Having received industry money, the argument goes, even an acknowledged world expert can no longer provide untainted advice. But is this divide between academic research ers and industry in our best interest? I think not — and I am not alone. The National Center for Advancing Translational Sciences of the National
N E J M .O R G
MAY 7, 2015
1853
The N E W E N G L A N D J O U R N A L o / M E D I C I N E
Institutes of Health, the President’s Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Well come Trust, and the Food and Drug Administra tion are but a few of the institutions encourag ing greater interaction between academics and industry, to provide tangible value for patients. A cogent example has been a vaccine against Ebola virus disease. All the candidate vaccines currently in trials have grown out o f collabora tions among academics, industry, funders, non governmental organizations, and patients. But Ebola is only the most recent crisis; we have yet to deal with the infectious threats o f human immunodeficiency virus (HIV), malaria, and tu berculosis and the noninfectious threats of can cer, heart disease, chronic lung disease, obesity, and diabetes. Simply put, in no area of medicine are our diagnostics and therapeutics so good that we can call a halt to improvement, and true im provement can come only through collaboration. How can the divide be bridged? And why do medical journal editors remain concerned about authors with pharma and biotech associations? The reasons are complex. This week we begin a series of three articles by Lisa Rosenbaum5 exam
This is an Online First article that has already been read by readers.
Disclosure forms provided by the author are available with the full text of this article at NEJM.org. 1. Waksman S. My life with the microbes. New York: Simon and Schuster, 1954. 2. Medical Research Council. Streptomycin treatment of pul monary tuberculosis. Br Med J 1948;2:769-82. 3. Waksman SA. Streptomycin and neomycin: an antibiotic ap proach to tuberculosis. Br Med J 1950;2:595-600. 4. Drazen JM, Curfman GD. Financial associations of authors. N Engl J Med 2002;346:1901-2. 5. Rosenbaum L. Reconnecting the dots — reinterpreting in dustry-physician relations. N Engl J Med 2015;372:1860-4. D O I : 1 0 . 1 0 5 6 /N E J M e l 5 0 3 6 2 3
Copyright © 2015 Massachusetts M edical Society.
Balancing the Risks and Benefits o f Dual Platelet Inhibition John F. Keaney.Jr., M.D.
Cardiovascular and cerebrovascular events com monly arise from atherosclerotic plaque rupture that produces platelet activation, thrombus for mation, and reduction o f blood flow to the brain or heart. The inhibition of platelets with aspirin is effective in the secondary prevention of acute coronary events.1 The addition of clopidogrel (i.e., dual antiplatelet therapy), a platelet P2Y12receptor antagonist, produces even greater sec ondary prevention of coronary events in highrisk patients for up to 1 year.2 Second-generation P2Y12 inhibitors (i.e., prasugrel and ticagrelor) produce further reductions in the risk of ische mic events over the same time frame, albeit with more bleeding complications.3’4 Dual antiplatelet therapy is recommended for 1 year after an acute coronary syndrome, but the effect of longer-term therapy is not clear.
1854
ining the current state of affairs. We hope that you will find the series engaging and provoca tive and that it will perhaps reshape the way you think about interactions between physician-scien tists and industry. Beginning at 5:00 p.m. (ET) on May 20, we will invite you to put yourself in the role o f a journal editor and to comment at NEJM.org on the suitability of three hypothetical potential authors of review articles. The ques tions will be challenging; we will report on the feedback from the community sometime in the summer. We look forward to the insight your comments may provide.
N ENGLJ
MED 372P 9
Concern exists regarding the balance between reducing the risk of cardiovascular events and the risk of bleeding complications, because bleed ing complications are linked to adverse outcomes in patients with an acute coronary syndrome.5 Bonaca et al., in the Prevention o f Cardiovascu lar Events in Patients with Prior Heart Attack Using Ticagrelor Compared with Placebo on a Background of Aspirin-Thrombolysis in Myo cardial Infarction 54 (PEGASUS-TIMI 54) trial,6 provide insight into this balance in high-risk pa tients with a previous myocardial infarction. In their study, the results of which are now report ed in the J o u r n a l, they randomly assigned 21,162 patients to placebo or ticagrelor. Because long term P2Y12 inhibition increases bleeding risk, the investigators compared two doses of ticagre lor (60 mg and 90 mg) to maximize information
N E JM .O R G
M A Y J, 2 0 1 5
Copyright © Massachusetts Medical Society 2015.
diseases, and promote healthy families. All health professionals know that in those with chronic and severe illness, care almost always relies in part on family. And when things get really dif ficult, as when life and death decisions need to be made, physicians know that talking with a patient’s partner is not legally the same as working with a patient’s spouse. Many same-sex couples are now raising children, and the health of those children demands that their parents have the full rights and protection o f marriage. In our society, marriage is often essential to ob taining and keeping adequate health insurance coverage for both members of a couple and for their children. More than 1000 federal benefits are conferred by marriage, among them access to family medical leave, Medicaid, and Veterans Affairs medical services. Some o f those bene fits, however, are in jeopardy for same-sex spouses in states that do not recognize their union. The current situation — with same-sex
marriages, including those in families with children, legally recognized in some states but not others — makes no sense, and the harmful consequences for health are well documented. The Supreme Court should require the full recognition of same-sex marriage throughout this country. If the Court rules otherwise, what ever the legal logic, a clear injustice will result. And that injustice would damage the health and welfare of millions o f Americans. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. T h is a r tic le w a s p u b lis h e d o n A p r il
22, 2015,
a t N E J M .o rg .
1. Bayer R. Homosexuality and American psychiatry: the poli tics of diagnosis. Princeton, NJ: Princeton University Press, 1987. 2. Monette P. Becoming a man: half a life story. New York: HarperCollins, 1992. 3. Gonzales G. Same-sex marriage — a prescription for better health. N Engl J Med 2014;370:1373-6. D O I: 10.1056/N E jM el505179 Copyright © 2015 Massachusetts Medical Society.
R evisiting th e C o m m e rc ia l-A c a d e m ic In terface Jeffrey M. Drazen, M.D.
In the mid-1940s, Selman Waksman, a soil micro biologist, and his team discovered streptomycin, an antibiotic with action against the tubercle bacillus.1 Although he was able to show efficacy in the laboratory, Waksman realized that if his discovery was to be of value to the world, he needed a partner capable o f manufacturing ade quate amounts o f the material under conditions that would make it suitable for use in humans. He therefore struck a deal with Merck to pro duce streptomycin for clinical use.1 Soon there after, the British Medical Association undertook a large randomized, controlled trial of strepto mycin for the treatment of tuberculosis. The re sults, including a description of the utility of streptomycin and resistance to it, were pub lished in the British Medical Journal.2 This partner ship between an academic researcher and a drug company went on to alleviate substantial human suffering and should be a model for current be havior. Unfortunately, it is not. In 1950, Waksman, who was arguably the
N
E N G L J M E D 3 7 2 ;1 9
world’s leading authority on antibiotic treatment of tuberculosis and who 2 years later received the Nobel Prize in Physiology or Medicine, was the sole author of a review article on streptomy cin and neomycin published in the British Medical Journal.3 That would most likely not happen to day. Over the past two decades, largely because of a few widely publicized episodes of unaccept able behavior by the pharmaceutical and bio technology industry, many medical journal edi tors (including me) have made it harder and harder for people who have received industry payments or items of financial value to write editorials or review articles.4 The concern has been that such people have been bought by the drug companies. Having received industry money, the argument goes, even an acknowledged world expert can no longer provide untainted advice. But is this divide between academic research ers and industry in our best interest? I think not — and I am not alone. The National Center for Advancing Translational Sciences of the National
N E J M .O R G
MAY 7, 2015
1853
The N E W E N G L A N D J O U R N A L o / M E D I C I N E
Institutes of Health, the President’s Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Well come Trust, and the Food and Drug Administra tion are but a few of the institutions encourag ing greater interaction between academics and industry, to provide tangible value for patients. A cogent example has been a vaccine against Ebola virus disease. All the candidate vaccines currently in trials have grown out o f collabora tions among academics, industry, funders, non governmental organizations, and patients. But Ebola is only the most recent crisis; we have yet to deal with the infectious threats o f human immunodeficiency virus (HIV), malaria, and tu berculosis and the noninfectious threats of can cer, heart disease, chronic lung disease, obesity, and diabetes. Simply put, in no area of medicine are our diagnostics and therapeutics so good that we can call a halt to improvement, and true im provement can come only through collaboration. How can the divide be bridged? And why do medical journal editors remain concerned about authors with pharma and biotech associations? The reasons are complex. This week we begin a series of three articles by Lisa Rosenbaum5 exam
This is an Online First article that has already been read by readers.
Disclosure forms provided by the author are available with the full text of this article at NEJM.org. 1. Waksman S. My life with the microbes. New York: Simon and Schuster, 1954. 2. Medical Research Council. Streptomycin treatment of pul monary tuberculosis. Br Med J 1948;2:769-82. 3. Waksman SA. Streptomycin and neomycin: an antibiotic ap proach to tuberculosis. Br Med J 1950;2:595-600. 4. Drazen JM, Curfman GD. Financial associations of authors. N Engl J Med 2002;346:1901-2. 5. Rosenbaum L. Reconnecting the dots — reinterpreting in dustry-physician relations. N Engl J Med 2015;372:1860-4. D O I : 1 0 . 1 0 5 6 /N E J M e l 5 0 3 6 2 3
Copyright © 2015 Massachusetts M edical Society.
Balancing the Risks and Benefits o f Dual Platelet Inhibition John F. Keaney.Jr., M.D.
Cardiovascular and cerebrovascular events com monly arise from atherosclerotic plaque rupture that produces platelet activation, thrombus for mation, and reduction o f blood flow to the brain or heart. The inhibition of platelets with aspirin is effective in the secondary prevention of acute coronary events.1 The addition of clopidogrel (i.e., dual antiplatelet therapy), a platelet P2Y12receptor antagonist, produces even greater sec ondary prevention of coronary events in highrisk patients for up to 1 year.2 Second-generation P2Y12 inhibitors (i.e., prasugrel and ticagrelor) produce further reductions in the risk of ische mic events over the same time frame, albeit with more bleeding complications.3’4 Dual antiplatelet therapy is recommended for 1 year after an acute coronary syndrome, but the effect of longer-term therapy is not clear.
1854
ining the current state of affairs. We hope that you will find the series engaging and provoca tive and that it will perhaps reshape the way you think about interactions between physician-scien tists and industry. Beginning at 5:00 p.m. (ET) on May 20, we will invite you to put yourself in the role o f a journal editor and to comment at NEJM.org on the suitability of three hypothetical potential authors of review articles. The ques tions will be challenging; we will report on the feedback from the community sometime in the summer. We look forward to the insight your comments may provide.
N ENGLJ
MED 372P 9
Concern exists regarding the balance between reducing the risk of cardiovascular events and the risk of bleeding complications, because bleed ing complications are linked to adverse outcomes in patients with an acute coronary syndrome.5 Bonaca et al., in the Prevention o f Cardiovascu lar Events in Patients with Prior Heart Attack Using Ticagrelor Compared with Placebo on a Background of Aspirin-Thrombolysis in Myo cardial Infarction 54 (PEGASUS-TIMI 54) trial,6 provide insight into this balance in high-risk pa tients with a previous myocardial infarction. In their study, the results of which are now report ed in the J o u r n a l, they randomly assigned 21,162 patients to placebo or ticagrelor. Because long term P2Y12 inhibition increases bleeding risk, the investigators compared two doses of ticagre lor (60 mg and 90 mg) to maximize information
N E JM .O R G
M A Y J, 2 0 1 5
Copyright © Massachusetts Medical Society 2015.
