News & Analysis Medical News & Perspectives ....p1000
Capitol Health Call .......................p1004
News From the CDC .....................p1005
As Ebola Epidemic Begins to Slow, Trials of Drugs and Vaccines Speed Up
Bill Would Authorize Medicare Payments for Pharmacists
Improved Infection Control Still Falls Short of National Goals
The JAMA Forum .........................p1002
GAO Finds Variations in Private Insurer Payments for Costly Procedures
Hospitalizations Among the Elderly
Why Does the Affordable Care Act Remain So Unpopular?
Bill Would Require Law-Breaking Drug Companies to Help Fund Research Outdated Regulatory Processes Delay New Treatments, Senators Say
Medical News & Perspectives
As Ebola Epidemic Begins to Slow, Trials of Drugs and Vaccines Speed Up Bridget M. Kuehn, MSJ
A
s local and international public health officials work to end the Ebola epidemic in West Africa, efforts to develop therapies and vaccines against the virus are ramping up. In late January, officials from the World Health Organization (WHO) announced that the Ebola epidemic had slowed. The WHO noted that for the first time since June 29, 2014, there were fewer than 100 new confirmed cases in the 3 hardest hit countries, Guinea, Liberia, and Sierra Leone (http://bit .ly/1LimWSP). “Things are currently trending in a good direction, suggesting growing control,” said Inger Damon, MD, PhD, the US Centers for Disease Control and Prevention’s (CDC’s) Ebola Response Team Incident Commander. “But there is still considerable work to be done.” International response efforts are shifting from reducing the number of new infections to trying to completely eliminate new infections. To do this, they are focusing on thorough contact tracing and surveillance of potentially exposed individuals for the 21day period during which symptoms may emerge. “When we do that efficiently, it allows us to rapidly identify new cases and break the chain of transmission,” Damon said. Damon and other experts are quick to caution that ongoing vigilance is necessary to prevent resurgence. About 200 CDC staff1000
ers remain in Guinea, Liberia, and Sierra Leone, providing technical advice on infection control, health communications, exit screening for travelers, and coordination of surveillance and contact tracing. “A single new case is enough to reignite an outbreak,” said Brice de le Vingne, Médecins Sans Frontières’ (MSF’s) director of operations in a statement on the organization’s website (http://bit.ly/15KGdfr). “Until everyone who has come into contact with Ebola has been identified, we cannot rest easy.”
Fast-Tracking Interventions The ongoing epidemic has sparked an unprecedented level of multinational cooperation to speed clinical trials of potential therapeutics and vaccines. Currently, the most effective treatment for Ebola virus disease is fluid and electrolyte replacement and other supportive care, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), during a press briefing hosted by the US Department of Health and Human Services (HHS) in late January (http://www.hhs.gov/news /press/2015pres/01/20150127a.html). There are no drugs proven to be safe and effective against Ebola virus disease, Fauci said. But some experimental therapies have been used to treat patients with Ebola virus disease under compassionate care exemptions. For example, several infected pa-
tients in the United States and other countries received ZMAPP, a combination of 3 different neutralizing antibodies against the Ebola virus, based on promising results from animal studies. Now ZMAPP and other therapies and vaccines are being fast-tracked into phase 1 and 2 clinical trials. Several interventions for Ebola currently entering early-phase clinical trials were developed years ago, said Thomas Geisbert, PhD, of the University of Texas Medical Branch at Galveston. But until the current large-scale, multicountry outbreak that began in 2013, there wasn’t a sense of urgency or much funding for clinical trials. “I’ve never seen anything like this,” said Geisbert. “It really was the outbreak that pushed things to the forefront.” In coming weeks, NIAID is planning to start phase 1 and phase 2 clinical trials of ZMAPP in the United States and Liberia in cooperation with the government of Liberia, Fauci said. The trial will undergo multiple reviews in the United States and Liberia before it begins and will be overseen by independent safety monitors, Fauci said. The trial organizersarealsoworkingcloselywithLiberiancommunity leaders, who played a critical role in containing the epidemic, Fauci said. “It is important to balance the urgency to deploy investigational medical countermeasures in an emergency with the need to evaluate these countermeasures through rigorously designed clinical trials,” Fauci said.
JAMA March 10, 2015 Volume 313, Number 10 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Fudan University User on 05/15/2015
jama.com
News & Analysis
Cases of Ebola Virus Disease in Guinea, Liberia, and Sierra Leone, March 25, 2014 – February 1, 2015 12 000
10 000
Reported Cases of Ebola
AFRICA 8000
6000
4000 Guinea Liberia Sierra Leone
2000
0 Mar 2014
Apr 2014
May 2014
Jun 2014
Jul Aug Sep Oct 2014 2014 2014 2014 Date of WHO Situation Report
Nov 2014
Dec 2014
Jan 2015
Feb 2015
Source: Centers for Disease Control and Prevention.
As the Ebola epidemic slows, efforts turn to accelerating clinical trials of investigational therapies.
To supply sufficient quantities of ZMAPP for the trial, the US Biomedical Advanced Research and Development Authority (BARDA) has worked with pharmaceutical companies that use tobacco plant–based biologic production systems to help scale up antibody production, said BARDA director Robin Robinson, PhD, during the HHS briefing. Robinson explained that tobacco-based products were chosen based on evidence from a nonhuman primate study demonstrating that antibodies produced in tobacco plants more effectively bind and neutralize the virus (Olinger GG et al. Proc Natl Acad Sci. 2012;109[44]:18030-18035). Robinson and his colleagues at BARDA also reached out to other manufacturers to try to develop ZMAPP-like products. Another therapeutic in development, known as TKM-Ebola, blocks the enzyme that catalyzes the replication of the Ebola virus and was found to protect against the disease in nonhuman primates (Geisbert TW et al. Lancet. 2010;375[9729]:1896-1905). In August 2014, the US Food and Drug Administration modified a hold it had placed on a phase 1 trial of the agent (http://bit.ly /1zYE3Cl), allowing it to be used on a compassionate basis in some patients infected with Ebola. Clinical trials of 2 antivirals, favipiravir and brincidofovir, were also launched in late 2014 at MSF treatment centers in West
Africa led by the French National Institute of Health and Medical Research and the University of Oxford, respectively (http://bit.ly /1LIZgqR). Blood and plasma from patients who survived an Ebola virus infection have also been used on a compassionate basis. This strategy capitalizes on Ebola antibodies in survivor’s blood, an approach that has been used successfully to treat other infections. Multiple clinical trials of convalescent whole blood and plasma are currently under way in the affected countries (Butler D. Nature. doi: 10.1038/nature.2014.16564 [published online December 15, 2014]). A recent analysis projected that transfusion therapy could save 151 to 3586 lives depending on the hospitalization rate and is an inexpensive and scalable intervention (Gutfraind A and Meyers LA. J Infect Dis. doi:10.1093/infdis /jiv042 [published online January 29, 2015]). Convalescent blood does carry the risk of potentially transmitting blood-borne disease, but experts note that the vaccine and antiviral therapies under investigation are expensive and may be hard to scale in resourcestrapped countries (Tully CM et al. Lancet Infect Dis. doi:10.1016/S1473-3099[14]71071-0 [published online January 13, 2015].
Accelerating Vaccine Trials Clinicaltrialsarealsoadvancingonexperimental vaccines against Ebola virus in the hopes of
jama.com
protecting frontline health workers, burial crews,andothersathighriskinfutureepidemics.Toachievethisgoal,theNationalInstitutes of Health (NIH) has collaborated with manufacturers of 2 different vaccines derived from theZairestrainofEbolavirus.Onevaccine,developed by NIAID and GlaxoSmithKline, uses chimpanzee adenovirus type 3 (ChAd3) as a vector to deliver noninfectious Ebola genes into the body to stimulate an immune response to the virus. The US Department of Defense has worked with NIH and comanufacturers NewLink and Merck to conductphase1trialsofanothervaccinethatuses vesicular stomatitis virus (VSV) as a vector. “A safe and effective Ebola vaccine will undoubtedly be a critically important tool to help prevent Ebola virus infections in future outbreaks,” said Fauci. The US and Liberian governments are jointly launching a phase 2-3 randomized double-blind trial that will compare both the VSVandChAd3Ebolavirusvaccinesandaplacebo in 27 000 health workers and others at risk in Liberia (http://1.usa.gov/16LmCMe). Preliminary results from a phase 1 trial of the ChAd3 vaccine in 60 health volunteers in United Kingdom reported no safety concerns and found that the vaccine stimulated an immune response (Rampling T et al. N Engl J Med. doi:10.1056/NEJMoa1411627 [published online January 28, 2015]). The immune response was not as robust as that seen in studiesofthevaccineinmacaques,buttheauthors suggest this might be remedied by adjusting the vaccine dose. The CDC is also preparing for a 6000person vaccine trial in Sierra Leone, said Anne Schuchat, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, during the HHS briefing. Participants in the phased-induction trial will be vaccinated on a rolling basis, and rates of infection in those vaccinated early will be compared with those vaccinated later. The agency hasn’t finalized whether they will use the VSV or ChAd3 Ebola virus vaccine for the trial, she said. Other Ebola vaccines are also in development, including one produced by Johnson & Johnson and another by Novavax (http://www.who.int/medicines/emp_ebola _q_as/en/). Geisbert said the head-to-head trial of the 2 leading vaccine candidates, ChAd3 and VSV, is helpful because it can be hard to predict how results from nonhuman primate studies will translate into humans. “It’s good to have options,” he said.
(Reprinted) JAMA March 10, 2015 Volume 313, Number 10
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Fudan University User on 05/15/2015
1001
News & Analysis
Challenges Ahead Major challenges remain for the affected countries and international groups working to eliminate the transmission of Ebola. The already fragile health systems of Liberia, Guinea, and Sierra Leone have suffered serious damage. More than 800 health workers have had confirmed Ebola infections and at least 488 have died of the disease, according to the WHO. Liberia is just beginning to reopen hospitals shuttered during the epidemic, and MSF is running mobile clinics to help meet primary care needs. “An added struggle is the paralysis of the public health system [in Sierra Leone],” said Karline Kleijer, MSF’s emergency coordinator, in a statement. “One in ten of the country’s health workers have died of Ebola, the medical facilities are in disarray, and people with non-Ebola illnesses struggle to get the treatment they need,” she said. Some populations have been difficult to reach, such as those communities in
forested areas of Guinea, or are resistant to public health measures aimed at reducing the spread of Ebola virus disease. In certain regions, it is customary to wash the body in preparation for burial, explained Damon. If proper precautions are not taken during this process, the high levels of virus still present on the body may infect others. Damon said that the CDC and others are working to develop alternative, safe burial practices, “that are respectful of religious beliefs and allow the family and clergy to be appropriately attired and protected.” Although sustained reductions in infection rates would be welcome news, the dwindling number of new infections could pose challenges for clinical trials that rely on large cohorts of patients to produce robust results. Already, Chimerix, the manufacturer of brincidofovir, ended its participation in the University of Oxford–led clinical trial of the drug for Ebola treatment, citing declining case numbers in Liberia (http://bit . l y/ 1 8 H J q h 0 ) .
Nonetheless, even trials with inadequate statistical power to demonstrate efficacy can still provide useful safety and subgroup efficacy data that can be used to gain approvals for an intervention, Fauci explained. Schuchat noted that the CDC Sierra Leone trial testing the efficacy of the yet-to-be-chosen vaccine has been designed to account for reduced cases. Some emerging evidence suggests that the Ebola virus might be evolving (Kugelman JR et al. MBio. doi:10.1128/mBio .02227-14 [published online January 20, 2015]). Geisbert and his colleagues are currently investigating genetic changes in the Ebola virus and acknowledge that this presents a valid concern, particularly because such changes could influence the effectiveness of experimental interventions in development. “Our work is focused on the leading candidate vaccines and therapies and making sure they still protect [against mutated forms of the virus],” he said.
The JAMA Forum
Why Does the Affordable Care Act Remain So Unpopular?
I
n mid-November, just as the second enrollment period for health insurance under the Affordable Care Act (ACA) was starting, a Gallup poll indicated that only 37% of the US public approved of the ACA—a record low percentage (http://bit.ly/1xOiNj8).
Since the ACA was passed in 2010, its overall approval rating has never been high, generally hovering in the low-to-mid 40% range. Approval of the law took a conspicuous dip in November 2013 after several million people received notices that their current policies were being cancelled. Not surprisingly, approval varies sharply by party: 74% of Democrats approve of the ACA vs only 8% of Republicans. What is more noteworthy is that the approval rate among political independents is also low, only 33% as of November 2014. Enthusiasm for the ACA has decreased even among nonwhites, who disproportionately identify as Democrats, with only 56% favoring the law compared with the 76% who reported they liked it when it passed.
Popular ACA Provisions
Gail Wilensky, PhD
1002
The ACA’s supporters have pointed out that some of the law’s features are very popular, much more so than the legislation as a whole (http://bit.ly/1yBMOF6). This is particularly
true for some of the insurance reforms, such as provisions that require insurers to allow young adults to stay on their parents’ health insurance policy until the age of 26 years, that prohibit insurance companies from denying coverage for preexisting conditions or charging enrollees higher rates because of preexisting conditions, and that limit the variations in premiums allowed for enrollees of different ages. Before the ACA’s passage, these changes were mentioned most frequently by President Obama in promoting the legislation’s passage and continue to be cited as important reforms associated with the law. What is rarely mentioned is that these popular measures carry almost no governmental costs (the higher insurance costs they produce are spread across everyone who buys insurance). What’s more, these measures could have been enacted as part of a narrow package of insurance reforms, providing many of the protections already provided to people with group insurance to
JAMA March 10, 2015 Volume 313, Number 10 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Fudan University User on 05/15/2015
jama.com
American Medical Association
Gail Wilensky, PhD
Capitol Health Call .......................p1004
News From the CDC .....................p1005
As Ebola Epidemic Begins to Slow, Trials of Drugs and Vaccines Speed Up
Bill Would Authorize Medicare Payments for Pharmacists
Improved Infection Control Still Falls Short of National Goals
The JAMA Forum .........................p1002
GAO Finds Variations in Private Insurer Payments for Costly Procedures
Hospitalizations Among the Elderly
Why Does the Affordable Care Act Remain So Unpopular?
Bill Would Require Law-Breaking Drug Companies to Help Fund Research Outdated Regulatory Processes Delay New Treatments, Senators Say
Medical News & Perspectives
As Ebola Epidemic Begins to Slow, Trials of Drugs and Vaccines Speed Up Bridget M. Kuehn, MSJ
A
s local and international public health officials work to end the Ebola epidemic in West Africa, efforts to develop therapies and vaccines against the virus are ramping up. In late January, officials from the World Health Organization (WHO) announced that the Ebola epidemic had slowed. The WHO noted that for the first time since June 29, 2014, there were fewer than 100 new confirmed cases in the 3 hardest hit countries, Guinea, Liberia, and Sierra Leone (http://bit .ly/1LimWSP). “Things are currently trending in a good direction, suggesting growing control,” said Inger Damon, MD, PhD, the US Centers for Disease Control and Prevention’s (CDC’s) Ebola Response Team Incident Commander. “But there is still considerable work to be done.” International response efforts are shifting from reducing the number of new infections to trying to completely eliminate new infections. To do this, they are focusing on thorough contact tracing and surveillance of potentially exposed individuals for the 21day period during which symptoms may emerge. “When we do that efficiently, it allows us to rapidly identify new cases and break the chain of transmission,” Damon said. Damon and other experts are quick to caution that ongoing vigilance is necessary to prevent resurgence. About 200 CDC staff1000
ers remain in Guinea, Liberia, and Sierra Leone, providing technical advice on infection control, health communications, exit screening for travelers, and coordination of surveillance and contact tracing. “A single new case is enough to reignite an outbreak,” said Brice de le Vingne, Médecins Sans Frontières’ (MSF’s) director of operations in a statement on the organization’s website (http://bit.ly/15KGdfr). “Until everyone who has come into contact with Ebola has been identified, we cannot rest easy.”
Fast-Tracking Interventions The ongoing epidemic has sparked an unprecedented level of multinational cooperation to speed clinical trials of potential therapeutics and vaccines. Currently, the most effective treatment for Ebola virus disease is fluid and electrolyte replacement and other supportive care, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), during a press briefing hosted by the US Department of Health and Human Services (HHS) in late January (http://www.hhs.gov/news /press/2015pres/01/20150127a.html). There are no drugs proven to be safe and effective against Ebola virus disease, Fauci said. But some experimental therapies have been used to treat patients with Ebola virus disease under compassionate care exemptions. For example, several infected pa-
tients in the United States and other countries received ZMAPP, a combination of 3 different neutralizing antibodies against the Ebola virus, based on promising results from animal studies. Now ZMAPP and other therapies and vaccines are being fast-tracked into phase 1 and 2 clinical trials. Several interventions for Ebola currently entering early-phase clinical trials were developed years ago, said Thomas Geisbert, PhD, of the University of Texas Medical Branch at Galveston. But until the current large-scale, multicountry outbreak that began in 2013, there wasn’t a sense of urgency or much funding for clinical trials. “I’ve never seen anything like this,” said Geisbert. “It really was the outbreak that pushed things to the forefront.” In coming weeks, NIAID is planning to start phase 1 and phase 2 clinical trials of ZMAPP in the United States and Liberia in cooperation with the government of Liberia, Fauci said. The trial will undergo multiple reviews in the United States and Liberia before it begins and will be overseen by independent safety monitors, Fauci said. The trial organizersarealsoworkingcloselywithLiberiancommunity leaders, who played a critical role in containing the epidemic, Fauci said. “It is important to balance the urgency to deploy investigational medical countermeasures in an emergency with the need to evaluate these countermeasures through rigorously designed clinical trials,” Fauci said.
JAMA March 10, 2015 Volume 313, Number 10 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Fudan University User on 05/15/2015
jama.com
News & Analysis
Cases of Ebola Virus Disease in Guinea, Liberia, and Sierra Leone, March 25, 2014 – February 1, 2015 12 000
10 000
Reported Cases of Ebola
AFRICA 8000
6000
4000 Guinea Liberia Sierra Leone
2000
0 Mar 2014
Apr 2014
May 2014
Jun 2014
Jul Aug Sep Oct 2014 2014 2014 2014 Date of WHO Situation Report
Nov 2014
Dec 2014
Jan 2015
Feb 2015
Source: Centers for Disease Control and Prevention.
As the Ebola epidemic slows, efforts turn to accelerating clinical trials of investigational therapies.
To supply sufficient quantities of ZMAPP for the trial, the US Biomedical Advanced Research and Development Authority (BARDA) has worked with pharmaceutical companies that use tobacco plant–based biologic production systems to help scale up antibody production, said BARDA director Robin Robinson, PhD, during the HHS briefing. Robinson explained that tobacco-based products were chosen based on evidence from a nonhuman primate study demonstrating that antibodies produced in tobacco plants more effectively bind and neutralize the virus (Olinger GG et al. Proc Natl Acad Sci. 2012;109[44]:18030-18035). Robinson and his colleagues at BARDA also reached out to other manufacturers to try to develop ZMAPP-like products. Another therapeutic in development, known as TKM-Ebola, blocks the enzyme that catalyzes the replication of the Ebola virus and was found to protect against the disease in nonhuman primates (Geisbert TW et al. Lancet. 2010;375[9729]:1896-1905). In August 2014, the US Food and Drug Administration modified a hold it had placed on a phase 1 trial of the agent (http://bit.ly /1zYE3Cl), allowing it to be used on a compassionate basis in some patients infected with Ebola. Clinical trials of 2 antivirals, favipiravir and brincidofovir, were also launched in late 2014 at MSF treatment centers in West
Africa led by the French National Institute of Health and Medical Research and the University of Oxford, respectively (http://bit.ly /1LIZgqR). Blood and plasma from patients who survived an Ebola virus infection have also been used on a compassionate basis. This strategy capitalizes on Ebola antibodies in survivor’s blood, an approach that has been used successfully to treat other infections. Multiple clinical trials of convalescent whole blood and plasma are currently under way in the affected countries (Butler D. Nature. doi: 10.1038/nature.2014.16564 [published online December 15, 2014]). A recent analysis projected that transfusion therapy could save 151 to 3586 lives depending on the hospitalization rate and is an inexpensive and scalable intervention (Gutfraind A and Meyers LA. J Infect Dis. doi:10.1093/infdis /jiv042 [published online January 29, 2015]). Convalescent blood does carry the risk of potentially transmitting blood-borne disease, but experts note that the vaccine and antiviral therapies under investigation are expensive and may be hard to scale in resourcestrapped countries (Tully CM et al. Lancet Infect Dis. doi:10.1016/S1473-3099[14]71071-0 [published online January 13, 2015].
Accelerating Vaccine Trials Clinicaltrialsarealsoadvancingonexperimental vaccines against Ebola virus in the hopes of
jama.com
protecting frontline health workers, burial crews,andothersathighriskinfutureepidemics.Toachievethisgoal,theNationalInstitutes of Health (NIH) has collaborated with manufacturers of 2 different vaccines derived from theZairestrainofEbolavirus.Onevaccine,developed by NIAID and GlaxoSmithKline, uses chimpanzee adenovirus type 3 (ChAd3) as a vector to deliver noninfectious Ebola genes into the body to stimulate an immune response to the virus. The US Department of Defense has worked with NIH and comanufacturers NewLink and Merck to conductphase1trialsofanothervaccinethatuses vesicular stomatitis virus (VSV) as a vector. “A safe and effective Ebola vaccine will undoubtedly be a critically important tool to help prevent Ebola virus infections in future outbreaks,” said Fauci. The US and Liberian governments are jointly launching a phase 2-3 randomized double-blind trial that will compare both the VSVandChAd3Ebolavirusvaccinesandaplacebo in 27 000 health workers and others at risk in Liberia (http://1.usa.gov/16LmCMe). Preliminary results from a phase 1 trial of the ChAd3 vaccine in 60 health volunteers in United Kingdom reported no safety concerns and found that the vaccine stimulated an immune response (Rampling T et al. N Engl J Med. doi:10.1056/NEJMoa1411627 [published online January 28, 2015]). The immune response was not as robust as that seen in studiesofthevaccineinmacaques,buttheauthors suggest this might be remedied by adjusting the vaccine dose. The CDC is also preparing for a 6000person vaccine trial in Sierra Leone, said Anne Schuchat, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, during the HHS briefing. Participants in the phased-induction trial will be vaccinated on a rolling basis, and rates of infection in those vaccinated early will be compared with those vaccinated later. The agency hasn’t finalized whether they will use the VSV or ChAd3 Ebola virus vaccine for the trial, she said. Other Ebola vaccines are also in development, including one produced by Johnson & Johnson and another by Novavax (http://www.who.int/medicines/emp_ebola _q_as/en/). Geisbert said the head-to-head trial of the 2 leading vaccine candidates, ChAd3 and VSV, is helpful because it can be hard to predict how results from nonhuman primate studies will translate into humans. “It’s good to have options,” he said.
(Reprinted) JAMA March 10, 2015 Volume 313, Number 10
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Fudan University User on 05/15/2015
1001
News & Analysis
Challenges Ahead Major challenges remain for the affected countries and international groups working to eliminate the transmission of Ebola. The already fragile health systems of Liberia, Guinea, and Sierra Leone have suffered serious damage. More than 800 health workers have had confirmed Ebola infections and at least 488 have died of the disease, according to the WHO. Liberia is just beginning to reopen hospitals shuttered during the epidemic, and MSF is running mobile clinics to help meet primary care needs. “An added struggle is the paralysis of the public health system [in Sierra Leone],” said Karline Kleijer, MSF’s emergency coordinator, in a statement. “One in ten of the country’s health workers have died of Ebola, the medical facilities are in disarray, and people with non-Ebola illnesses struggle to get the treatment they need,” she said. Some populations have been difficult to reach, such as those communities in
forested areas of Guinea, or are resistant to public health measures aimed at reducing the spread of Ebola virus disease. In certain regions, it is customary to wash the body in preparation for burial, explained Damon. If proper precautions are not taken during this process, the high levels of virus still present on the body may infect others. Damon said that the CDC and others are working to develop alternative, safe burial practices, “that are respectful of religious beliefs and allow the family and clergy to be appropriately attired and protected.” Although sustained reductions in infection rates would be welcome news, the dwindling number of new infections could pose challenges for clinical trials that rely on large cohorts of patients to produce robust results. Already, Chimerix, the manufacturer of brincidofovir, ended its participation in the University of Oxford–led clinical trial of the drug for Ebola treatment, citing declining case numbers in Liberia (http://bit . l y/ 1 8 H J q h 0 ) .
Nonetheless, even trials with inadequate statistical power to demonstrate efficacy can still provide useful safety and subgroup efficacy data that can be used to gain approvals for an intervention, Fauci explained. Schuchat noted that the CDC Sierra Leone trial testing the efficacy of the yet-to-be-chosen vaccine has been designed to account for reduced cases. Some emerging evidence suggests that the Ebola virus might be evolving (Kugelman JR et al. MBio. doi:10.1128/mBio .02227-14 [published online January 20, 2015]). Geisbert and his colleagues are currently investigating genetic changes in the Ebola virus and acknowledge that this presents a valid concern, particularly because such changes could influence the effectiveness of experimental interventions in development. “Our work is focused on the leading candidate vaccines and therapies and making sure they still protect [against mutated forms of the virus],” he said.
The JAMA Forum
Why Does the Affordable Care Act Remain So Unpopular?
I
n mid-November, just as the second enrollment period for health insurance under the Affordable Care Act (ACA) was starting, a Gallup poll indicated that only 37% of the US public approved of the ACA—a record low percentage (http://bit.ly/1xOiNj8).
Since the ACA was passed in 2010, its overall approval rating has never been high, generally hovering in the low-to-mid 40% range. Approval of the law took a conspicuous dip in November 2013 after several million people received notices that their current policies were being cancelled. Not surprisingly, approval varies sharply by party: 74% of Democrats approve of the ACA vs only 8% of Republicans. What is more noteworthy is that the approval rate among political independents is also low, only 33% as of November 2014. Enthusiasm for the ACA has decreased even among nonwhites, who disproportionately identify as Democrats, with only 56% favoring the law compared with the 76% who reported they liked it when it passed.
Popular ACA Provisions
Gail Wilensky, PhD
1002
The ACA’s supporters have pointed out that some of the law’s features are very popular, much more so than the legislation as a whole (http://bit.ly/1yBMOF6). This is particularly
true for some of the insurance reforms, such as provisions that require insurers to allow young adults to stay on their parents’ health insurance policy until the age of 26 years, that prohibit insurance companies from denying coverage for preexisting conditions or charging enrollees higher rates because of preexisting conditions, and that limit the variations in premiums allowed for enrollees of different ages. Before the ACA’s passage, these changes were mentioned most frequently by President Obama in promoting the legislation’s passage and continue to be cited as important reforms associated with the law. What is rarely mentioned is that these popular measures carry almost no governmental costs (the higher insurance costs they produce are spread across everyone who buys insurance). What’s more, these measures could have been enacted as part of a narrow package of insurance reforms, providing many of the protections already provided to people with group insurance to
JAMA March 10, 2015 Volume 313, Number 10 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Fudan University User on 05/15/2015
jama.com
American Medical Association
Gail Wilensky, PhD
