News - meMedicinehttp://www.memedicine.org/blog/Sun, 07 Feb 2016 17:55:33 +0000en-USSite-Server v6.0.0-8256-8256 (http://www.squarespace.com)Exploring Accessibility to IUDs: Insertion During Cesarean DeliveryNewsSabrina MeroldWed, 08 Jul 2015 20:00:00 +0000http://www.memedicine.org/blog/2015/9/21/exploring-accessibility-to-iuds-insertion-during-cesarean-delivery56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:560061a2e4b0dbc400a52de7In a study, Intrauterine device (IUD) Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial, published in Obstetrics and Gynecology, researchers found that IUD placement at the time of cesarean delivery resulted in a higher proportion of IUD use at 6 months postpartum.In a study, Intrauterine device (IUD) Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial, published in Obstetrics and Gynecology, researchers found that IUD placement at the time of cesarean delivery resulted in a higher proportion of IUD use at 6 months postpartum.

IUD Background

An IUD is a small, plastic, flexible device that is inserted into a woman’s uterus as a form of contraception known for being safe, effective, and long lasting according to Planned Parenthood. IUDs are accessible in the United States in two forms. One type releases the hormone progestin. Progestin hinders the ability of sperm to reach the egg by causing the cervical mucus to become thicker and also changes the lining of the uterus so that implantation of a fertilized egg cannot occur. All IUDs are not made the same. Hormonal IUDs that are available include Mirena, which can be implanted for up to 5 years, and Skyla, which can be for up to 3 years. The other type of IUD does not involve hormones but instead contains copper, which is released into the uterine cavity. Copper hinders the sperm from making it into the vagina and uterus to reach the egg, impacting fertilization. One copper IUD is accessible, the ParaGard T380A, which can be implanted for up to 10 years. A health care provider inserts IUDs to offer long-term yet reversible birth control

Study Objective

The objective of the study was to compare IUD use at 6 months postpartum for women who had “intracesarean delivery (during cesarean delivery)” IUD placement in comparison to women who had interval IUD placement at 6 or more weeks postpartum. Researchers noted that postponing the use of effective contraception until the postpartum visit places some women at risk for “rapid, repeat, and unintended pregnancy,” as “more than 50% of non-breastfeeding women ovulate by 6 weeks postpartum” and over 50% of women are sexually active at the time of 6 weeks postpartum. Some women who plan to use an IUD as a form of postpartum contraception cannot return for a postpartum visit and do not receive the IUDtypically socially or economically disadvantaged women who face barriers to returning for additional care.

Study Methods

The study was a non-blinded randomized trial conducted from March 2012 until June 2014 at the North Carolina Women’s Hospital where 112 pregnant women aged 18-45 were recruited who were undergoing a cesarean delivery and wanted an IUD for postpartum contraception. Following written consent, 56 participants were randomly placed into intracesarean delivery IUD placement (within 10 minutes of placental delivery) and 56 were randomly placed into interval IUD insertion at a visit 6 or more weeks following delivery. After being randomized into the condition of insertion, the women chose either a hormonal IUD (Mirena) or a copper IUD (ParaGard). Researchers provided the IUDs to the women free of charge with the criteria that the women who participated in the study were English or Spanish speaking, had the intention to comply with the follow up visits at 6 weeks and 3 and 6 months postpartum, and had the cesarean delivery of a live born neonate at greater than 24 weeks of gestation. Residents and faculty at the hospital obtained a 10-minute training from the principal researchers of the study on IUD insertion. For the intracesarean delivery group, IUDs were placed using the “hysterotomy after the delivery of the neonate and the placenta.”

During study visits, participants filled out a questionnaire about their experience with their IUD including their satisfaction, level of pain, and amount of bleeding. A medical examination was conducted to confirm IUD location. Researchers were primarily evaluating IUD use at 6 months postpartum and were also tracking the outcomes of IUD expulsion (no IUD within the uterus), discontinuation, the visibly of IUD strings at 6 months postpartum, and women’s satisfaction with the IUD (a satisfactory response of yes to “Would you recommend an IUD as a method of contraception to a friend?”).

Results

The final sample group at the 6-month visit consisted of 48 out of 56 women (86%) in the intracesarean delivery group and 50 out of 56 women (89%) in the intervals arms. Researchers noted no significant difference for the women lost to follow up compared to the women who had follow up data available. For the women in the intracesarean delivery group, 53 out of 56 (95%) received an IUD at the time of cesarean delivery (two women had the IUD placed at their 6 week visit) with 40 (73%) choosing a hormonal IUD and 15 (27%) picking a copper IUD.

Among the 56 women who received an interval IUD insertion, 34 (63%) had an IUD successfully inserted with 30 (86%) women choosing a hormonal IUD and 4 (14%) women picking a copper IUD. For the 22 women who did not receive an IUD, 14 (25%) did not return for any study visit, 5 (9%) declined an IUD at the follow up visit, and for 3 women, due to medical complications, an IUD could not be successfully inserted (5%). The researchers found that at the final 6 month visit, a greater proportion of the intracesarean delivery group were using an IUD (40/48, 83%) in comparison to the interval group (32/50, 64%) with a relative risk (RR) of 1.3, meaning that if you were in the intracesarean delivery group, you were 30% more likely to be using an IUD.

That being said, the results need to be seen in the context of the entire sample. There was a 14% loss to follow up in the intracesarean delivery group and an 11% loss in the interval IUD placement group with researchers noting that baseline characteristics were similar for the women in both groups. When the researchers factored in “if the same proportion of IUDs (83%) in the intracesarean delivery group were retained among the women who were lost to follow up as the cohort for whom follow up data were available, the proportion of IUDs retained was 82% (46/56) in the intracesarean delivery group and 57% (32/56) in the interval group, a slightly larger effect size between intervention groups (RR = 1.44),” meaning that if you were in the intracesarean delivery group you were 44% more likely to be using an IUD.

In terms of secondary outcomes:

  • In the intracesarean delivery group, 4 women experienced expulsions within the first three weeks and one woman in the interval group had an expulsion of her IUD. All the women who suffered expulsions used hormonal IUDs.
  • In the intracesarean delivery group, 7 women (15%) had IUDs removed before 6 months postpartum for medical reasons. In the interval group, 2 women (4%) had IUDs removed for medical reasons during the study period.
  • Overall, 55 women returned for an in person 6 month study visit and had a speculum examination so that the health practitioner could inspect for IUD string visibility with 56% in the intracesarean delivery group and 75% in the interval groups having visible strings. In both groups, if the IUD was a hormonal IUD then it was more likely that the strings were visible at 6 months postpartum.
  • In terms of satisfaction, 92% (36/39) of women in the intracesarean delivery group and 100% of women in the interval group (30/30) would recommend an IUD as a method of contraception to a friend.

Analysis/Findings

Researchers designed the study so that IUD access would be free to the participants and that the participants would receive compensation for attending each study visit, yet 25% of participants did not return for any visit following their delivery. Prior data suggests that “women who do not return for postpartum visits are more likely to be socially and economically disadvantaged and that for some women attendance to a visit represents a barrier to IUD initiation and placement.” Thus, researchers believe these study findings offer another contraceptive option to women, an IUD, without the need for a postpartum visit for insertion. The researchers also note that the study population came from North Carolina Women’s Hospital, a hospital with significant racial, ethnic, and socioeconomic diversity, which might have “contirbuted to some loss to follow up among women in this study.” Loss to follow up is highlighted as a weakness of the study in addition to the fact that researchers did not perform a cost benefit analysis of the effectiveness of providing state funded postpartum IUDs during intracesarean delivery.

Going forward, if IUDs are offered to women for insertion following cesarean delivery, researchers indicated that those women should be advised about the potential of IUD expulsion and that their strings might not be visible. Additionally, one of the main barriers to the use of a long acting reversible contraception method (LARC), like an IUD, during the postpartum period is reimbursement policies. According to the study, “as of December 2014, 11 states in the United States have adopted Medicaid policies that allow for reimbursement of LARC devices placed during the admission for delivery.” Researchers believe that the combination of: policy changes, the future aligning of reimbursement policies with insertion practices, the results from the study, and the support of the American Congress of Obstetricians and Gynecologists for the “immediate postplacental IUD placement” all favor increasing the accessibility of intracesarean delivery IUD insertion.

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Exploring Accessibility to IUDs: Insertion During Cesarean Delivery
Uncovering the Extent of Smoking Related Deaths NewsSabrina MeroldMon, 23 Mar 2015 20:00:00 +0000http://www.memedicine.org/blog/2015/9/21/uncovering-the-extent-of-smoking-related-deaths56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:560075b0e4b02ea8d85feaccAccording to the Centers for Diseases Control and Prevention, roughly 42 million adult Americans smoke – 15% of women and 20% of men. The United States Surgeon General currently has a list of 21 deadly diseases caused by smoking, which result in an estimated 437,000 deaths per year.According to the Centers for Diseases Control and Prevention, roughly 42 million adult Americans smoke – 15% of women and 20% of men. The United States Surgeon General currently has a list of 21 deadly diseases caused by smoking, which result in an estimated 437,000 deaths per year. A recent study in The New England Journal of Medicine, “Smoking and Mortality – Beyond Established Causes,” examined additional diseases, bringing into question the official approximates on the number of deaths attributable to smoking. Researchers combined data from five US cohort studies that followed people from 2000 through 2011 with a joined sample of 421,378 men and 532,651 women age 55 or older, including roughly 89,000 current smokers.

Researchers found that among the study sample, there were 181,377 deaths with 16,475 deaths among current smokers. The most interesting finding was that “approximately 17% of the excess mortality among current smokers was due to associations with causes that are not currently established as attributable to smoking,” adding roughly an additional 60,000 smoking related deaths a year in the United States. In comparison to people who had never smoked, smokers were roughly twice as likely to die from infections, renal failure, respiratory ailments not previously associated with tobacco, and hypertensive heart disease. Smokers were also six times more likely to die from intestinal ischemia, when blood flow is reduced to the intestines. Researchers noted that smokers were 30% more likely to die of breast cancer than nonsmokers and 40% more likely to die of prostate cancer. The study found that the more heavily a person smoked, the greater the additional risk, and for former smokers, the risk decreased over time.

It is important to note that this study was observational, examining people’s smoking habits and the correlation of their smoking behavior and their health. Due to its methodology, the study cannot claim causal links between behavior and health, only claiming associations with smoking. One of the researchers, Dr. Eric Jacobs, proposed potential mechanisms for how smoking can result in some of the illnesses found in the study. For instance, smoking can suppress the immune system, a reason why there are high rates of death by infection among smokers. In terms of kidney disease, smoking has been found to cause diabetes, high blood pressure, and artery disease, which can cause kidney failure. Lung damage due to smoke and increased risk for infection can result in respiratory illnesses. As smokers are also more likely to consume alcohol and high alcohol consumption increases the risk of breast cancer, researchers were cautious to establish a direct link between smoking and breast cancer.

Taking into account the additional 60,000 deaths due to smoking from this study, the total number of smoking related deaths per year in the United States grows to roughly half a million people a year – 1 in 5 deaths overall in the US. While a spokesman for the US Surgeon General has indicated that the official list of 21 diseases caused by smoking will not be changed as a result of this study, going forward, the new findings will be reviewed in future assessments.

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Uncovering the Extent of Smoking Related Deaths
Violence Against Women at Unacceptably High LevelsNewsSabrina MeroldMon, 23 Mar 2015 20:00:00 +0000http://www.memedicine.org/blog/2015/9/21/violence-against-women-at-unacceptably-high-levels56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:5600ad29e4b0451b20c91ada“Women’s rights are human rights.” Those are the words of Hillary Clinton at The United Nations Fourth World Conference on Women in Beijing in 1995. Recently, UN Women released Summary Report: The Beijing Declaration and Platform for Action Turns 20 in light of the 59th session of the Commission on the Status of Women which took place from March 9th to the 20th.“Women’s rights are human rights.” Those are the words of Hillary Clinton at The United Nations Fourth World Conference on Women in Beijing in 1995.

Recently, UN Women released Summary Report: The Beijing Declaration and Platform for Action Turns 20 in light of the 59th session of the Commission on the Status of Women which took place from March 9th to the 20th. The session focused on reviewing progress made in the 20 years since the adoption of the Beijing Declaration and Platform for Action to achieve gender equality and the empowerment of women at the Fourth World Conference on Women in 1995. In the foreword to the recent report the Executive Director of UN WomenDr. Phumzile Mlambo-Ngcuka, called the report “a wake-up call” as the world in the 20 years since Beijing “has not, in the main, improved much for women and girls, and for some has got a lot worse.”

Even though progress has occurred in some countries, no country has achieved gender equality. The Executive Director noted that progress has been stalled due to “forces in the global political and economic landscape that have been particularly hard to mitigate or combat.” These forces include: continued conflicts; the global financial and economic crises; unstable food and energy prices; climate change; extremist and directed backlash against women’s rights; and gender discrimination that is “deeply entrenched” in the minds of individuals, institutions, and societies. UN Women has set 2030 as the expiration date for gender inequality because “gender equality and the realization of women’s and girls’ human rights are fundamental for achieving human rights, peace and security, and sustainable development.”

One section of the report focuses on trends in the implementation of the Beijing Declaration and Platform for Action in terms of violence against women. The report found that all regions have “unacceptably high rates of violence against women,” as global estimates reveal that 35% of women worldwide have “experienced either physical and/or sexual intimate partner violence or non-partner sexual violence in their lifetime.” One of the biggest obstacles for stopping violence against women is the continuation of discriminatory attitudes and social norms that “normalize and permit violence.” The Platform for Action adopted in 1995 recognized violence against women as a violation of women’s human rights and fundamental freedoms, hindering abilities to achieve equality, development, and peace.

Statistics:

  • Intimate Partner Violence:
    • In terms of low and middle income regions, Africa has the highest proportion of women reporting either physical and/or sexual intimate partner violence or non-partner sexual violence at 45.6% followed by South East Asia (40.2%), Eastern Mediterranean (36.4%), the Americas (36.1%), Western Pacific (27.9%), and Europe (27.2%).
    • In high-income countries, 32.7% of women have experienced either physical and/or sexual intimate partner violence in their lifetime.
    • Intimate partner violence is the most prevalent form of violence women experience, which tends to lead to injury and can result in death.
    • In 2013, the United Nations Office on Drugs and Crime released The Global Study on Homicide 2013, finding that almost half of female homicide victims are killed by an intimate partner or family members, while for men, the statistics are slightly above 1 in 20 homicide victims.
  • Seeking Help or Support:
    • In March 2014, the European Union Agency for Fundamental Human Rights conduced a study Violence Against Women: An EU-Wide Survey. Among data of 42,000 women from 28 member states of the European Union, researchers found that only one-third of victims of partner violence and one-quarter of victims of non-partner violence reached out to the police or support services after the most serious incident of violence.
  • Victim-Blaming:
    • A UN Women analysis of Demographic Health Surveys from 37 developing countries between 2009 and 2014 found that 21% of women believe that a husband is “justified in beating his wife if she argues with him” and 27% of women believe that a husband is “justified in beating his wife if she neglects the children.”
    • The study Intimate Partner Violence Against Women and Victim-Blaming Attitudes Among Europeans was conducted by Enrique Gracia and published in the Bulletin of the World Health Organization in 2014. Individuals in 15 out of 27 member states of the European Union were asked, “whether women’s behavior was the cause of domestic violence against women.” An average of 52% of individuals agreed with the statement.
  • Global Trafficking:
    • The United Nations Office on Drugs and Crime’s Global Report on Trafficking in Persons released in 2012 found that women represent between 55% and 60% of all trafficking victims detected globally with women and girls combined reaching 75%. In addition, 27% of victims are children and “of every three child victims two are girls and one is a boy.”
  • Sexual Harassment:
    • The same March 2014 study Violence Against Women: An EU-Wide Survey conducted by the European Union Agency for Fundamental Human Rights found that of 42,000 women, 55% reported experiencing sexual harassment at least once since the age of 15 and one in five indicated experiencing sexual harassment in the period of 12 months prior to the survey.
  • Female Genital Mutilation:
    • UNICEF estimates that in 2013 over 125 million girls and women “had undergone some form of female genital mutilation/cutting in 29 countries across Africa and the Middle East.” In the next decade, predictions are that an additional 30 million girls are at risk of being cut. While data indicates that the practice is decreasing in prevalence in approximately half of the 29 countries studied, due to population growth, the number of women affected by female genital mutilation/cutting is rising.
  • Child, Early, and Forced Marriage:
    • UNICEF estimates that “over 700 million women alive in 2014 were married before their 18th” Even though the practice of child marriage is declining, it is still largely prevalent in countries in sub-Saharan Africa and South Asia.

Going forward, the report noted the urgent need for the implementation of “strong and comprehensive legal and policy frameworks which address all forms of violence against women in all countries.” As the issue of violence against women impacts so many other sectors, the report calls for the integration of response and prevention of violence against women within larger policy frameworks including: national development plans, health, education, security, and justice policies. Laws, policies, and programs focused on addressing violence against women need to also take into account the factors that make marginalized women and girls at an increased risk of violence and the factors that establish an environment where women who are victims of violence can find support. States additionally need to improve their efforts to collect and report data on violence against women. “Women’s rights are human rights” and it is time that all countries start viewing violence against women as a human rights violation – more generally an impediment to their country’s progress – and respond accordingly to prevent it.

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Violence Against Women at Unacceptably High Levels
E-Cigarettes: A Bustling Market with Uncertain EffectsNewsSabrina MeroldTue, 13 Jan 2015 21:00:00 +0000http://www.memedicine.org/blog/2015/9/21/e-cigarettes-a-bustling-market-with-uncertain-effects56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:5600a59de4b02a26d751d15dThe majority of electronic cigarettes (e-cigarettes) function by heating a liquid, which contains tobacco derived nicotine, propylene glycol, vegetable glycerin, and flavorings. While propylene glycol and vegetable glycerin are not carcinogenic when ingested, researchers are unclear about the long-term health effects of inhaling them.The majority of electronic cigarettes (e-cigarettes) function by heating a liquid, which contains tobacco derived nicotine, propylene glycol, vegetable glycerin, and flavorings. While propylene glycol and vegetable glycerin are not carcinogenic when ingested, researchers are unclear about the long-term health effects of inhaling them. During the process of inhalation, either a battery-powered atomizer is activated or manually switched on. Inside the atomizer, a heating coil heats liquid nicotine, causing it to become vapor, which is then inhaled. According to the World Health Organization report, “Electronic nicotine delivery systems,” the capacity of electronic nicotine delivery systems (ENDS) “to deliver nicotine to the user varies widely, ranging from very low to levels similar to that of cigarettes, depending on product characteristics, user puffing behavior, and nicotine solution concentration.”  

Monitoring the Future 2014

 The National Institute on Drug Abuse released in December 2014 “Monitoring the Future 2014,” an annual survey conducted by researchers at the University of Michigan of 8th, 10th, and 12th graders measuring attitudes towards and use of drugs, alcohol, and cigarettes. The survey population consisted of 41,551 students from 377 public and private schools. Over the past two decades (1994-2014), cigarette use has mainly decreased. In 2014, 13.6% of 12th graders reported past 30-day use of cigarettes, 7.2% of 10th graders, and 4.0% of 8th graders. When comparing cigarette and e-cigarette past 30-day use, researchers found that teens were more likely to use e-cigarettes than cigarettes with 8.7% of 8th graders, 16.2% of 10th graders, and 17.1% of 12th graders reporting e-cigarette use. An additional research finding was that only 14.2% of 12th graders saw e-cigarette use as harmful, which the researchers noted is “less than 5 students in the average class.” Prior Monitoring the Future surveys did not record data on e-cigarettes, providing no comparative data to assess change over time.

Tobacco use Among Students – United States, 2013

The CDC released in November 2014 “Tobacco use Among Middle and High School Students – United States, 2013,” detailing findings from the National Youth Tobacco Survey for 2013. The National Youth Tobacco Survey is a self-administered questionnaire completed by US middle (grades 6-8) and high school (grades 9-12) students that assesses ever and current use (1 or more days in the past 30 days) of tobacco products including e-cigarettes. In the 2013 survey, 187 schools participated from 250 selected with a sample of 18,406 students and a response rate of 67.8%. The survey found that 22.9% of high school students reported current use of a tobacco product. Among high school students, “4.5% reported using e-cigarettes within the last 30 days; and 1.1% of middle school students reported using e-cigarettes in the last 30 days.” In comparison with results from the 2012 National Youth Tobacco Study, e-cigarette use among high school students rose from 2.8% but remained the same for middle school students. The difference in the two findings from “Monitoring the Future 2014” and the National Youth Tobacco Survey might be explained by a methodological difference of reporting data from individual grades versus combining grades (6-8, 9-12).

Intentions to Smoke National Youth Tobacco Survey, 2011-2013

In August 2014, the journal Nicotine & Tobacco Research published a study “Intentions to Smoke Cigarettes Among Never-Smoking U.S. Middle and High School Electronic Cigarette Users, National Youth Tobacco Survey, 2011-2013” examining e-cigarette use among middle and high school students who have never smoked cigarettes. The study used student-reported information collected in connection with the National Youth Tobacco Survey from 2011-2013. Researchers explored data from students enrolled in grades 6-12 in both public and private schools. The researchers from the CDC, FDA, and Georgia State University found that from 2011-2013 the number of students who had “never smoked a cigarette but had used e-cigarettes at least once increased three-fold” from 79,000 in 2011 to over 263,000 in 2013. Additionally the study reported that students who had never smoked but had used e-cigarettes “were nearly twice as likely to have an intention to smoke conventional cigarettes” in comparison to never smokers who had not used e-cigarettes, 43.9% to 21.5%.

E-Cigarette Use Among High School and Middle School Adolescents in Connecticut

Published in November 2014 in the journal Nicotine & Tobacco Research, “E-Cigarette Use Among High School and Middle School Adolescents in Connecticut” used data from anonymous surveys conducted in four high schools and two middle schools in Connecticut in November 2013 to assess knowledge and use of e-cigarettes. Researchers found that 84.3% of middle school students and 92% of high school students were aware of e-cigarettes. Lifetime use of e-cigarettes was 3.5% and 25.2% for middle and high school students respectively. Among middle school students, 1.5% reported current use of e-cigarettes while the number was 12% for high school students. Interestingly, for middle school students who were lifetime e-cigarette users, “51.2% reported that e-cigarette was the first tobacco product they had tried.” The study found that rechargeable and sweet flavors were the most popular types of e-cigarettes.

Aiding Recruitment or Quitting

In December 2014, The Cochrane Collaboration published, “Electronic cigarettes for smoking cessation and reduction.”In the study, researchers examined 13 trials up until July 2014, focusing specifically on two trials that assigned people to treatment groups, comparing e-cigarettes with and without nicotine. The trials were conducted in New Zealand and Italy with a combined sample size of 662 participants. Both trials assessed whether people had attempted to quit smoking for at least six months and used early models of e-cigarettes that contained low nicotine content. In one study, people did not want to quit smoking while in the other study, which also compared e-cigarettes to nicotine patches, people wanted to quit smoking. Based upon the results from these two studies, researchers noted that use of e-cigarettes that contains nicotine “increased the chances of stopping smoking long-term compared to using e-cigarettes without nicotine.” In addition, e-cigarette use with nicotine was found to help smokers “reduce the amount they smoked by at least half compared to using an e-cigarette without nicotine.” From the findings available, researchers could not determine if e-cigarettes were more successful than nicotine patches in helping people quit smoking due to a low sample size. However, the original study did indicate that people who used e-cigarettes were more likely to reduce the amount they smoked “by at least half than people using the patch.” The researchers called for future studies to assess the effectiveness of e-cigarettes in helping people quit smoking.

At the same time, other experts in public health have expressed concern that e-cigarettes are a gateway for young individuals to start using real cigarettes. In December 2014, “Risk Factors for Exclusive E-Cigarette Use and Dual E-Cigarette Use and Tobacco Use in Adolescents” was published in the journal Pediatrics, assessing e-cigarette and cigarette use among adolescents. Researchers in Hawaii collected data in 2013 using a school-based survey from 1,941 high school students. The findings showed that 17% of students only used e-cigarettes, 12% used both, 3% used only cigarettes, and 68% were nonusers. With the survey, researchers also assessed “psychosocial risk and protective variables (eg, parental support, academic involvement, smoking expectancies, peer smoking, and sensation seeking),” finding that dual users and users of only cigarettes were “highest on the risk status (elevated on risk factors and lower on protective factors).” Students who only used e-cigarettes had a higher risk status than nonusers but were lower than dual users. The researchers concluded that because e-cigarette only users “were intermediate in risk status between nonusers and dual users” it “raises the possibility that e-cigarettes are recruiting medium-risk adolescents, who otherwise would be less susceptible to tobacco product use.”

Restrictions and Going Forward

The US FDA currently does not regulate e-cigarettes, but it has begun the process. Proposed FDA regulation would force manufacturers of e-cigarettes to win “premarket” approval of their products in two years or remove the products from the market. In a letter on November 24, 2014, House Speaker John Boehner (R-Ohio), House Majority Leader Kevin McCarthy (R-California), and House Energy and Commerce Committee Chairman Fred Upton (R-Michigan) wrote to Health and Human Services Secretary Sylvia Burwell asking for changes to the scheduled FDA regulations on e-cigarettes and calling for existing e-cigarette products to be able to remain on the market.

States have also taken action against e-cigarettes. A study, “State Laws Prohibiting Sales to Minors and Indoor Use of Electronic Nicotine Delivery Systems (ENDS),” was released from the CDC in December 2014. Researchers examined state laws finding that as of November 30, 2014, “40 states prohibited ENDS sales to minors, but only three states prohibited ENDS use in private worksites, restaurants, and bars.”

E-cigarettes are growing in popularity in the United States, particularly among young individuals. According to an analysis by Wells Fargo Securities, the firm estimates that in 2014, sales of e-cigarettes in the US reached roughly $1.7 billion. Research is continuing to be conducted examining the effects of e-cigarette use. Hopefully with a better understanding of the impact of e-cigarettes, states and the FDA will respond with appropriate restrictions and regulations.

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E-Cigarettes: A Bustling Market with Uncertain Effects
Longer Surgery, Greater RisksNewsEmily MagillMon, 08 Dec 2014 21:00:00 +0000http://www.memedicine.org/blog/2015/9/21/longer-surgery-greater-risks56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:5600a96ce4b0270cd4b94a12Under the American College of Surgeons’ National Surgical Quality Improvement Program from 2005 to 2011, more than 1.4 million patients undergoing surgery at US hospitals were observed to see if lengthier surgery durations would affect the risk of developing a blood clot, or venous thromboembolism (VTE).Under the American College of Surgeons’ National Surgical Quality Improvement Program from 2005 to 2011, more than 1.4 million patients undergoing surgery at US hospitals were observed to see if lengthier surgery durations would affect the risk of developing a blood clot, or venous thromboembolism (VTE). We’ve known that being bound to a hospital bed (common after surgery) is a risk factor for VTEs, but this is the first evidence that surgery duration is a risk factor as well.

Doctors fear venous thromboses because they often break into fragments called emboli that are then carried back to the heart by the blood stream. Emboli can eventually obstruct the smaller blood vessels in the lungs, hindering oxygenation. The hypoxemia (low oxygen) can ultimately lead to death.

In the hospital we give patients anticoagulants like heparin to prevent VTEs and recommend wearing sequential compression devices (SCDs) on the calves. SCDs intermittently inflate causing increased blood flow through the veins, which means less opportunity for VTEs to develop.  There are also studies that suggest a molecular mechanism for SCDs role in anticoagulation.

The authors looked at rates of blood clots in patients that occurred within 30 days of surgery and found that those who had longer surgery duration were at greater risk (1.27 times greater for the lengthiest surgeries). This is true of even the most common general surgeries including laparoscopic cholecystectomy, appendectomy, and gastric bypass.

500,000 Americans are hospitalized due to VTEs every year, which means that reducing post-surgical VTE risk has impressive implications in terms of reducing patient mortality and costs of care. It’s also important for hospitals that are institutionally incentivized by the Patient Protection and Affordable Care Act to drive down readmissions for surgical complications.

This study stands out because it demonstrates an avenue for improving patient safety and reducing medical costs. For example, evidence-based protocols might be developed to routinely screen patients who had the lengthiest surgery durations for VTEs. Noentheless, more research is still needed. We need to see that these findings are reproducible in different populations, begin to define “lengthiest surgery duration”, and create a model that can reliably stratify multifactorial risk.

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Longer Surgery, Greater Risks
Kidney Shortage for TransplantationNewsEmily MagillSun, 23 Nov 2014 21:00:00 +0000http://www.memedicine.org/blog/2015/9/21/kidney-shortage-for-transplantation56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:5600aa5be4b07b1035d01670As of this morning almost 102,000 Americans were waiting for a kidney. If that number doesn’t strike you, then consider that this number is 1/3 of the total number of kidneys ever transplanted in the United States.As of this morning almost 102,000 Americans were waiting for a kidney. If that number doesn’t strike you, then consider that this number is 1/3 of the total number of kidneys ever transplanted in the United States.

Only 15,000 of these 100,000 potential recipients are expected to receive a kidney before the end of the year, which means that 85,000 will still be waiting for surgery come the new year.

The unmet demand for kidney transplants grows while the number of donors plateaus. Some commentators have suggested that permitting organ sales would solve this crisis. in fact, the Wall Street Journalpublished an article in support of an organ market in January of 2014. The authors emphasized,

Any claim about the supposed immorality of organ sales should be weighed against the morality of preventing thousands of deaths each year and improving the quality of life of those waiting for organs.

The conversation also simmers at the local level. At SUNY Downstate‘s 2nd Annual Transplantation Symposium “Controversies in Kidney Transplantation”, Dr. Eli Friedman (pro) and Dr. Lainie Ross(against) debated the possibility of opening a market for kidney sales in the United States.

Like the writers at the WSJ, Dr. Friedman took a moral relativistic stance. We’ve already allowed selling our bodies (eggs, sperm, bone marrow, sex) so why not add kidneys to the list? His “Trial Plan” consists of 5 components:

  1. Remove Legal Strictures
  2. Set Price ($25,000/deceased)
  3. Retain UNOS and Supervision
  4. Live Donor Payment ($50,000)
  5. Evaluate at 1 and 2 years

Dr. Ross was appalled that patients could be reduced to their parts for financial gain. She denied that markets are merely efficient means to distribute goods because the poor will be coerced to sell their newly commoditized organs, corrupting the value of a kidney. In our egalitarian society, there is no room for a kidney market, she says.

Her most compelling argument was that organ donors/vendors are currently lost to follow-up and suffer negative economic, psychological, and medical consequences. Physicians take on donors and vendors as their patients by virtue of harvesting their organs. Thus, physicians have the obligation to act in accord with the ethical principles of beneficence and non-malficence. Given the current standard of donor/vendor post-op care as indicated by Dr. Ross’s literature review, it would be immoral for physicians to support organ sales.

But what if we could improve the economic, psychological, and medical outlook for the sellers? If there was no reason to believe that kidney sellers were at a concrete disadvantage compared to kidney donors, then could we really argue against the market?

Perhaps a two-pronged approach of fostering a culture of organ donation and allowing kidney sales with guaranteed economic, psychological, and medical support could close the gap between the number of patients transplanted and those who are still waiting. That is until, technology catches up, and patient’s are transplanted with organs grown from their own cells.

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Kidney Shortage for Transplantation
Sovaldi Update: Compliance Less Than PerfectNewsSabrina MeroldMon, 22 Sep 2014 20:00:00 +0000http://www.memedicine.org/blog/2015/9/29/sovaldi-update-compliance-less-than-perfect56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:560a9a8be4b0774c42e22afbIn a study “Analysis of “Real World” Sovaldi Use and Discontinuation Rates”  by CVS Health, researchers found that roughly 8% of patients who took Sovaldi to treat Hepatitis C discontinued the treatment regimen before its conclusion. During the clinical trials for Sovaldi, Gilead Sciences’ “breakthrough therapy,” only 2% of patients discontinued therapy, raising questions about Sovaldi’s effectiveness in a real world patient population where patients are normally sicker, older, have more complications, and are not observed as carefully in comparison to a clinical trial.In a study “Analysis of “Real World” Sovaldi Use and Discontinuation Rates” by CVS Health, researchers found that roughly 8% of patients who took Sovaldi to treat Hepatitis C discontinued the treatment regimen before its conclusion. During the clinical trials for Sovaldi, Gilead Sciences’“breakthrough therapy,” only 2% of patients discontinued therapy, raising questions about Sovaldi’s effectiveness in a real world patient population where patients are normally sicker, older, have more complications, and are not observed as carefully in comparison to a clinical trial.

The study population consisted of patients who were “continuously eligible with CVS/caremark for 44 months” to establish previous use of any Hepatitis C regimen and patients who began a Hepatitis Cregimen with Sovaldi on or before May 15, 2014 to determine rates of discontinuation or treatment completion. Of the eligible population of 1,965 patients, treatment naïve patients, who have not taken Hepatitis C drugs before and have less advanced Hepatitis C disease, were “64% more likely to discontinue therapy with Sovaldi than treatment experienced patients.” The report also noted that come late September or October of 2014, experts expect a considerable increase in use when Gilead Sciences will release a new treatment regimen for Hepatitis C that combines Sovaldi and Ledipasvir, an inhibitor of a Hepatitis C virus protein, into a single pill taken once daily for 8 weeks. The report concludes that patients who receive Sovaldi should be “followed closely by their providers to support adherence to therapy.” For a drug like Sovaldi, which costs $1,000 per pill and $84,000 for a 12-week course of treatment, it is imperative to take into account its clinical benefit and value in real patient populations when doctors decide to prescribe Sovaldi and decisions are made to prioritize treatment for those with more advanced Hepatitis C.

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Sovaldi Update: Compliance Less Than Perfect
Arrested DevelopmentNarrativeEmily MagillMon, 22 Sep 2014 17:49:00 +0000http://www.memedicine.org/blog/2016/1/15/arrested-development56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:56993e88c21b8619545c99a4It began in the middle of America when two years ago God told her, let’s pretend her name is Mary, that she must “seek medical care.”  Mary had just finishing packing her groceries into the car when out of nowhere she heard a voice that she recognized as God.It began in the middle of America when two years ago God told her, let’s pretend her name is Mary, that she must “seek medical care.”  Mary had just finishing packing her groceries into the car when out of nowhere she heard a voice that she recognized as God. The voice told her that she needed medical attention. God didn’t tell her why, but only that she needed it. Mary had faith in her creator, so she moved across the country with her daughter to her sister’s apartment to find the best medicine that she could afford.

Mary saw several doctors, none of whom could find evidence of disease. After exhausting the outpatient circuit, she made regular visits to the Emergency Department near her sister’s apartment, never bringing specific complaints, but more so a general concern that something was wrong. The work-up was consistently negative so she was referred to follow-up with the many local clinics.

When Mary told me her story, I could tell this was an extremely difficult time for her. The expert doctors, whom she respected greatly, did not seem to agree with her God.

That all changed last month when she developed abdominal discomfort. Her friends at the emergency room performed an ultrasound, which was within normal limits, and a subsequent CT scan, which showed an appendiceal mass.

She was referred to the General Surgery clinic where she was further evaluated and scheduled for an appendectomy. The pre/post-operative course was uneventful. The procedure went smoothly and the recovery was steady. Mary believed she had been cured.

I met Mary in the pre-operative holding area for her 2nd surgery. She was back in the hospital because the histopathology from the the appendectomy showed mucinous adenocarcinoma of the appendix. The neoplastic mass was greater than 2cm, an indication for right hemicolectomy.

Mary told me her story between IV placement, blood draws, a physical exam, and the ritual informed consent. It didn’t matter to her the reason for surgery or the possible risks. She sang, quite beautifully, about being in her Lord’s hands, so all was well from her perspective.

We took a laparoscopic approach to the hemicolectomy. A 12-mm blunt Hasson trocar was inserted through the umbilicus and two additional trocars were placed: one superiorly and one inferiorly. Once we were able to visualize the abdominal cavity with full attention, we realized something was wrong. There were mucinous implants littered throughout the abdomen.

The surgeons and residents were talking across the operating table about these implants until I interrupted and asked, “What’s an implant?” One of them told me they were cancerous growths that had sprouted from the original tumor. Some were tiny and others were large like the one shown to the left. When the implants invade the abdomen like in our patient, the condition is called Pseudomyxoma Peritonei. 

When this happens, surgery is no longer sufficient. It needs to be paired with chemotherapy called Hyperthermic Intraperitoneal Chemotherapy (HIPEC).  First the chemotherapeutic agents are heated to above body temperature, then the surgical team physically rocks the patient back and forth on the operating table for 90-120 minutes making sure all of the abdominal contents are coated in the chemotherapy. Patients who receive this treatment are generally very sick, and rely on a feeding tube or IV nutrition for approximately 2 weeks until the gut recovers from the treatment.

Mary was never consented for HIPEC, only a hemicolectomy, so nothing more could be done for her in the operating room. The chief surgeon made the executive decision to collect biopsies, snap a few photos, and close the abdomen.

Mary woke up 15 minutes later lethargic and disoriented, like all post-operative patients. Hours later she had returned to her cheery, faithful self. The chief resident and a fellow medical student explained to her that we found cancer beyond the intestines and needed to discuss a new therapeutic strategy.

But this was no concern for her, she just sang a song about her Lord, and told us, “Do what needs to be done, He will take care of the rest.”

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Breakthrough Hepatitis C Drug and Its Controversial CostNewsSabrina MeroldWed, 10 Sep 2014 20:00:00 +0000http://www.memedicine.org/blog/2015/9/21/sovaldi56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:5600ad99e4b0b133a4b1a225Hepatitis C is a liver disease that results from the Hepatitis C virus (HCV). Roughly 3.2 million individuals in the United States have chronic HCV infection and infection is most prevalent among individuals born from 1945-1965 with the majority of those individuals infected during the 1970s to 1980s when infection rates were at their highest. Approximately 15,000 lives are lost each year due to HCV infection.Hepatitis C is a liver disease that results from the Hepatitis C virus (HCV). Acute HCV infection is a milder form of the illness that appears during the first 6 months following exposure to the HCV and is typically asymptomatic, making early diagnosis uncommon. According to the CDC, “Approximately 15-25% of persons clear the virus from their bodies without treatment and do not develop chronic infection.” Thus, 75-85% of patients with acute HCV infection turn into chronic HCV infection, 60% to 70% develop chronic liver disease, 5% to 20% develop cirrhosis in a period of 20 to 30 years, and 1% to 5% die from either liver cancer or cirrhosis. The HCV is transmitted through large or continuous percutaneous exposures to blood infected with the virus. The virus has an incubation timeframe of 2 to 24 weeks with roughly 80% of patients after the initial infection not showing any symptoms. Those testing positive for HCV infection should have a laboratory test conducted to indicate the genotype of the HCV as there are 6 genotypes that respond differently to treatment.

Roughly 3.2 million individuals in the United States have chronic HCV infection and infection is most prevalent among individuals born from 1945-1965 with the majority of those individuals infected during the 1970s to 1980s when infection rates were at their highest. Approximately 15,000 lives are lost each year due to HCV infection.

Sovaldi, the Drug

Sovaldi is part of a combination antiviral treatment regimen for chronic HCV infection, developed by Gilead Sciences. In December of 2013, the United States Food and Drug Administration approved Sovaldi to treat chronic HCV infection. According to the U.S. FDA, Sovaldi is “the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.” Depending upon the genotype of the HCV, a patient’s treatment regimen with Sovaldi might involve Sovaldi and ribavirin or Sovaldi, ribavirin, and peginterferon-alfa. Ribavirin and peginterferon-alfa are drugs taken to treat the HCV infection. Clinical trial results showed that a treatment regimen using Sovaldi proved to be effective for treating multiple genotypes of the HCV. Sovaldi was also effective in participants who could not handle or use an interferon based treatment regimen and among participants with liver cancer awaiting liver transplantation, in what the FDA calls “addressing unmet medical needs in these populations.”

Sovaldi has been labeled a “breakthrough therapy” because of both its effectiveness and reduction of side effects in comparison to existing therapies. Existing therapies usually involved treating with a combination of daily drugs and up to 48 weeks of weekly injections of interferon, which had potentially terrible side effects and was only effective roughly half the time. With Sovaldi, patients might still receive interferon injections but because Sovaldi is taken as a daily dose for 12 weeks, the timeframe is much more manageable and greatly reduces the severity of the side effects. In terms of effectiveness, Gregg Alton, Gilead Sciences Executive VP, Corporate and Medical Affairs, has stated “It’s really changing the landscape of Hepatitis C and the ability to treat Hepatitis C from a largely untreatable disease to one we can cure with a more than 90% rate.” In the first 30 weeks on the market, 62,000 patientsreceived Sovaldi and as of the end of July 2014, according to Gilead Sciences, roughly 9,000 Hepatitis C patients have been cured with Sovaldi.

Gilead Sciences, Inc.

Gilead Sciences, Inc. is a research focused biopharmaceutical company that discovers, produces, and commercializes therapeutics. Gilead Sciences focuses its research efforts on treatments for HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. In 2011, Gilead Sciences bought Pharmasset, Inc. for $11 billion, the original developer of Sovaldi. With Sovaldi, the company had the most successful drug launch on record with $2.3 billion in sales in the first quarter of 2014. Sovaldi alone made up approximately 54% of the company’s revenue in the second quarter of 2014 bringing in $3.48 billion in second quarter profits.

In the US, Sovaldi has been receiving attention not just because of its labeling as a “breakthrough therapy” but also because of the controversy over its pricing. The 12-week regimen of Sovaldi costs $84,000, equating to $1,000 per pill. In a commentary by Troyen Brennan, MD, MPH and William Shrank, MD, MSHS, two scientists with CVS Caremark Corporation, when companion medications, ribavirin and peginterferon-alfa, are taken into account the price of the treatment becomes $117,000.

Gilead Sciences’ Pricing Strategy

While in the United States, Sovaldi costs $84,000 that is not the case in other countries. Mr. Alton told The Wall Street Journal that Gilead Sciences has established three basic pricing tiers based on a country’s per capita income and HCV prevalence that “serve as the starting point for negotiations with national governments.” The pricing tiers are low income, low middle income, and upper middle income. In India and Egypt, countries with high rates of Hepatitis C, the drug will be offered at $900 for the treatment, a 99% discount of the US price of Sovaldi. That being said, Indian officials have noted that 80% of their population is without insurance and even the reduced price of $900 is out of reach for many infected individuals. According to Tracy Swan, HIV/Hepatitis Project Director for Treatment Action Group, “Almost all Egyptians with Hepatitis C have genotype 4, which may require 24 weeks of treatment.” In addition, the $900 or $1,800 price is only for Sovaldi and does not take into account the price of the other drugs used in the treatment regimen, as Sovaldi cannot be used alone.

Price Justifications and Value, Price, Cost:

John Milligan, President and Chief Operating Officer of Gilead Sciences, has referred to Sovaldi as “it is an outlier because we are curing people of a horrible disease in a very rapid time frame and that’s a very unusual thing for payers to think about.” Gilead Sciences believes that because Sovaldi can cure 9 out of 10 patients, these patients who could have needed more expensive treatments, such as liver transplants, will now not, saving society money in the long run. In July of 2014, Senators Ron Wyden (D-OR), Chairman of the Senate Committee on Finance, and Charles Grassley (R-IA), a veteran of drug safety investigations, sent a letter requesting documents from Gilead Sciences to provide a thorough explanation of how the company arrived at its retail price for Sovaldi. Members of the Senators’ staffs discovered public documents that show that in 2011 filings with federal regulators, Pharmasset, the original developer of Sovaldi, estimated the price of treatment at $36,000. Gilead Sciences is complying with the request but Mr. Alton has stated in a public forum sponsored by the American Enterprise Institute “to suggest that a cure for a disease like Hepatitis C should be priced at $36,00 would put a huge disincentive on investing in cures for our industry” and lobbyists for drug makers have said that Sovaldi’s price is justified because of the expense of the research that goes into developing “breakthrough therapies.” For Ms. Swan, Sovaldi should be assessed in terms of its value, cost, and price. She believes that Sovaldi’s “value is enormous, the price is extortionate, and the cost is—and should be—low.” Ms. Swan makes a key distinction between price and cost. In December of 2014, researchers at the University of Liverpool published a paper inthe journal Clinical, Infectious Diseases, which found that the cost to manufacture Sovaldi was between $68 and $136 for a 12-week regimen and between 95 cents and $1.89 per pill, much lower than their retail price.

What impact will Sovaldi’s price actually have?

The problem is that Sovaldi appears to be a mass-market drug, as it could treat a large population of 3 million in the United States, yet has the price of a specialty drug, which are typically designed for smaller patient populations. Sovaldi has a 90% cure rate for patients with HCV but that cure takes only 12 weeks, so the high price of the treatment is not spread out over many years, which would be the case for costly HIV/AIDS treatments. Thus in a commentary, Troyen Brennan, MD, MPH and William Shrank, MD, MSHS, two scientists with CVS Caremark Corporation, estimated that treatment of HCV could raise every American’s health insurance premium for the next 5 years from $200 to $300 a year.

Medicaid and State Prisons

According to Ms. Swan, “It is easy to put all the blame on Gilead for their pricing policy, but States are using it as an excuse not to cover hepatitis C treatment.” State Medicaid programs, which provide insurance for families and individuals with low incomes and those who are disabled, are required by law to cover any drug that is approved by the US FDA. Medicaid receives a 23% discount for the purchase of Sovaldi, bringing the drugs price to $770 per pill. According to an estimate by Express Scripts, roughly 750,000 Americans infected with Hepatitis C are enrolled in Medicaid or in the prison system, which means that state programs fund their healthcare, so Dr. Steve Miller, Express Scripts’ Chief Medical Officer, in a statement to The Wall Street Journal said “the unsustainable pricing of this medication has essentially become a tax on all Americans.” If every person in the United States infected with the HCV received Sovaldi, states could spend over $55 billion. Express Scripts released a state-by-state analysis of Sovaldi’s impact on Medicaid and state prison budgets. The study revealed the top five states in terms of highest per capita spending costs are: Louisiana at $1.4 billion or $294 per resident, Delaware at $265 per resident, Mississippi at $259 per resident, Oklahoma at $223 per resident, and Texas at $200 per resident.

In Oregon, it would cost the state $360 million to provide Sovaldi to Medicaid beneficiaries. Oregon’s Medicaid program has a special waiver from the federal government that permits it to take into account a drug’s cost effectiveness when it comes to providing coverage. Thus, Oregon is only making Sovaldi available to the sickest patients, which will cost the state $40 million. In Illinois, officials instituted 25 criteria for using Sovaldi, which consist of treating only patients with the most advanced stage of liver disease and limiting treatment for those with a history of drug use and alcohol abuse. According to The Associated Press, in the current fiscal year, Illinois has spent $16 million on Sovaldi. State prison budgets are also feeling pressure from Sovaldi’s pricing, as approximately one-third of people infected with the HCV in the US are in prisons and jails. While Medicaid programs are legally required to receive drug discounts, state prion systems typically pay retail prices for prescription drugs. The Federal Bureau of Prisons released a policy document detailing how it would dispense Sovaldi to its inmates, as many states are rationing Sovaldi or not providing it.

Medicare

Medicare ensures access to health insurance for Americans aged 65 and older and Medicare Part D is a US government program to subsidize the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries. Researchers from Georgetown University and the Kaiser Family Foundation looked at two different scenarios to understand how Sovaldi at 12 weeks and $84,000 will impact Medicare and its beneficiaries. The lower-end scenario estimated that 25,000 Medicare beneficiaries receive Sovaldi, approximately 10% of all Part D enrollees with the HCV and roughly ¼ of enrollees who have been diagnosed. The higher-end scenario estimates that 75,000 Part D enrollees receive Sovaldi, almost all enrollees who are aware that they are infected. The lower-end scenario would raise Medicare Part D spending by $2 billion in new Part D drug costs in 2015, a 3% increase, while the higher-end scenario would raise spending by $6.5 billion, an increase of roughly 8%. According to the research, Medicare Part D premiums would also increase by 3% to 8% in 2015. Medicare has stated that it expects average premiums to increase by $1 in 2015. According to Jack Hoadley, a health policy analyst and researcher at Georgetown University and a co-author of the research, Medicare’s announcement that premiums remain flat with 2014 is “not necessarily inconsistent with their findings. Without Sovaldi, as a result of the lowering of drug costs in recent years, premiums could have gone down otherwise.”

Is Price the Only Issue?

At Oregon Sciences and Health University (OSHU), the Medicaid Evidence Based Decisions (MED) Project, independently and objectively evaluates effectiveness of treatments by examining clinical evidence to improve decision-making in Medicaid programs. Sixteen state Medicaid agencies participate in the MED Project. The MED Project conducted a report “Sofosbuvir for the Treatment of Hepatitis C and Evaluation of the 2014 American Association for the Study of Liver Diseases Treatment Guidelines,” evaluating in an evidence review of 10 studies the effectiveness and harms of using Sovaldi (Sofosbuvir) to treat HCV. The report indicated that there were no controlled trials for Sovaldi and Sovaldi was tested among a small and selective population. According to Dr. Valerie King, Research Director Center for Evidence-based Policy, and Dr. Allison Leof, PhD, Senior Policy Analyst at the Center for Evidence-based Policy, authors of the report, “Major objections states have with one very minor exception is that published research has been conducted in populations very unlike the clients in their Medicaid programs.” The minor exception referred to is the 2013 study “Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial,” sponsored by the National Institutes of Health, which found that among a population of patients with a “high prevalence of unfavorable predictors of treatment response, a 24-week regimen of sofosbuvir (Sovaldi) and low-dose ribavirin” had a cure rate between 68% and 48%. Dr. King notes that this study “found effectiveness rates no better than standard treatment” yet this study was “very small and didn’t have the right drug cocktail.”

Arvind Goyal, Medical director for the Illinois Department of Health Care and Family Services was quoted in an interview with The Wall Street Journal as saying that when the Illinois Department of Health Care and Family Services analyzed the research Gilead Sciences provided to the FDA to understand the extent of Sovaldi’s effectiveness “we had questions because in the Medicaid population many of the people we serve are minorities and these people were not included in the research that was conducted.” According to Dr. Leof, “Population relates to the success of any treatment and people enrolled in the studies were likely to do better. There was no true control group so we don’t know how much better or worse.” In terms of policymakers considering use, the report details factors to consider for policymakers when prioritizing patients for Sovaldi treatment. Dr. King noted that, when the FDA approved the first two direct antivirals on the market in 2011, telaprevir and boceprevir, it “looked like the side effect profile was really favorable” but then “in post marketing surveys it became very clear that the risk of any adverse side effects and severe effects was substantial. Although the new drug appears to be relatively safe it hasn’t been studied among a real population.”

Going Forward

At this point, time will reveal the extent of the value and effectiveness of Sovaldi and the impact of its price. Going forward, a wrinkle emerges to Gilead Sciences’ justification that Sovaldi will save money in the long term as it cures patients of HCV. Many people change health plans over time or become eligible for Medicare, thus the same group might not feel the cost and benefit of the long-term savings. Come October, Gilead Sciences is predicted to gain approval by the US FDA for a pill that combines Sovaldi with another drug, creating discussion over whether new HCV treatments to reach the market in the next couple of years will be as effective and at a lower cost and will create any competition to lower Sovaldi’s price. Sovaldi came to the market as a “breakthrough therapy” and created discussion for its impact on the Hepatitis C virus, but it also stimulated a dialogue over how to make life saving treatments more affordable while also remembering that the drug companies who develop these life saving treatments are corporations with incentives.

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Breakthrough Hepatitis C Drug and Its Controversial Cost
Strategie to Increase MMR VaccinationsNewsEmily MagillMon, 30 Jun 2014 20:00:00 +0000http://www.memedicine.org/blog/2015/9/29/strategie-to-increase-mmr-vaccinations56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:560a9b5ee4b0a09442e45c3dIn the United States, cases of measles, a highly contagious respiratory disease, are at a 20-year highwith 288 confirmed cases just between January 1 and May 23, 2014. The Centers for Disease Control (CDC) reports that 90%  of these cases were in people who did not have the measles, mumps, and rubella (MMR) vaccine with 85% choosing not to vaccinate due to religious, personal, or philosophical reasonsThe Situation

In the United States, cases of measles, a highly contagious respiratory disease, are at a 20-year highwith 288 confirmed cases just between January 1 and May 23, 2014. The Centers for Disease Control (CDC) reports that 90% of these cases were in people who did not have the measles, mumps, and rubella (MMR) vaccine with 85% choosing not to vaccinate due to religious, personal, or philosophical reasons. Cases were clustered in diverse locations: roughly half of the cases in an Ohio Amish community, 60 cases in California’s Orange County and San Francisco Bay Area, and 26 cases in February in Upper Manhattan in New York City, spreading from a hospital waiting room.

While cases are on the rise, roughly 10 million doses of the MMR vaccine are provided to Americans each year. The CDC recommends two doses of the MMR vaccine, one at ages 12-15 months and one at 4-6 years. According to a CDC report of the 2012-2013 school year, in 48 states and DC, 94.5% of students had both doses of the MMR vaccine, ranging from 85.7% in Colorado to 99.9% in Mississippi. For those choosing not to vaccinate, depending upon the state, there can be up to three types of vaccine exemptions: medical, religious, and philosophical. Of the estimated 4,242,558 kindergartners in the US, there were 91,453 vaccine exemptions. To increase the number of children vaccinated, some states are choosing to advocate for vaccines by proposing parental educational mandates. The question remains – which strategies are best at raising vaccination levels?

The Study

To explore this question, Brendan Nyhan, PhD, Jason Reifler, PhD, Sean Richey, PhD, and Gary Freed, MD, MPH, conducted a 2014 study, “Effective Messages in Vaccine Promotion: A Randomized Trial,” assessing the success of four strategies often used by public health agencies to decrease vaccine misperceptions and raise the levels of MMR vaccination. The study, conducted from June to July 2011, randomly assigned 1,759 parents (18 or older) in the US with children age 17 or younger in their household to either an intervention adapted mainly from the CDC or a control, information on bird feeding. The interventions consisted of:

  • Autism correction, using scientific evidence to disprove the vaccine-autism link
  • Disease risks, detailing symptoms and negative events as a result of MMR
  • Disease narrative, a story of a mother whose infant son contracted measles
  • Disease images, pictures of children with each disease (measles, mumps, and rubella)

The experiment was conducted as a nationally representative two-wave online survey. Participants were first asked: about the health of their children, agree/disagree questions to determine vaccine attitudes prior to the intervention, if they have ever postponed or refused a vaccine, how they view the personal importance of vaccines, and how they trust health professions and institutions. After the interventions, participants responded to questions to evaluate three outcomes: misperceptions of the vaccine-autism link, concerns about suffering side effects from MMR, and intent to have future children receive the MMR vaccine.

According to Brendan Nyhan, the study found that when it comes to the Autism correction intervention, “beliefs and behaviors do not line up.” While the Autism correction intervention decreased participants’ views of the vaccine-autism link from 8.9% among controls to 5.1%, it had an unintended effect on the intent to vaccinate future children in participants with the least favorable vaccine attitudes, which dropped from 70% in controls to 45%. The effectiveness of corrective information, in Nyhan’s opinion, is encouraging, but at the same time highlights an unintended consequence of provoking people with the least favorable vaccine attitudes to find other concerns to defend their general views on vaccines. Results for the other three interventions were not much better. The Disease risks intervention did not significantly impact participants’ beliefs of the vaccine-autism link or concerns of MMR side effects. The Disease narrative intervention increased concerns of MMR side effects from 7.7% in controls to 13.8% and the Disease images intervention did not impact concerns of MMR side effects but raised beliefs of the vaccine-autism link from 8.9% in controls to 12.6%. The increases with the Disease narrative and Disease images interventions, according to Nyhan, were a result of making the adverse health consequences of vaccines more cognitively accessible. Overall, none of the interventions raised parental intent to have future children receive the MMR vaccine.

The Implications

This study found no strong positive evidence towards any of the four common public health interventions assessed but raised many questions in terms of future research. In a previous studyconducted by one of the researchers, Dr. Gary Freed, participants rated their children’s doctor as the most trusted source of information on vaccine safety, bringing into question whether resistance to the information provided in the interventions was due to the credibility of the source and if pediatricians could be a particularly persuasive source. While Nyhan is skeptical that misperceptions of vaccines can be corrected through messaging from public health agencies, he encourages them to test the effectiveness of health messages on impacting both beliefs and behavioral intent prior to implementation, particularly among those with the least favorable attitudes. Ultimately, Nyhan believes the most effective approach consists of a combination of aiding pediatricians to be excellent advocates and assessing vaccine exemption policies at the state and local level, as the difficulty of acquiring an exemption varies by state.

In some states, action has been taken to connect parents and healthcare providers. A law went into effect in Oregon in March 2014 that requires parents to consult a medical provider and sign a vaccine education certificate before exempting kindergartners from receiving vaccines. Prior to this law, according to the CDC, in the 2012-2013 school year, Oregon had the highest school vaccination exemptions for kindergarteners at 6.5%. Oregon’s law is similar to those passed in 2011 in Washington, requiring a health care provider’s approval for an exemption, and in 2012 in California, requiring a conversation with a healthcare provider about vaccine risks and benefits. However, California’s policy has been questioned as it provides an option for parents to not talk to a health care provider if religion prevents the parent from obtaining medical advice or treatment from a healthcare provider.

Healthcare providers could play a crucial role in correcting vaccine misperceptions by providing vaccine information, but vaccines are a tricky issue. While the groups who are most likely to not vaccinate their children are diverse, in terms of religion, culture, socioeconomic status, and levels of education, among the groups, a common challenge exists in overcoming vaccine misperceptions. According to Nyhan, it is difficult to get people to change their minds because vaccine misperceptions are “linked to political beliefs or cultural value systems.” This is a challenge public health agencies must take into account in order to effectively advocate for vaccines at the state level, combat vaccine misperceptions, and ultimately increase vaccination levels.

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Strategie to Increase MMR Vaccinations
Save Lives. Play Video Games?NewsEmily MagillFri, 16 May 2014 20:00:00 +0000http://www.memedicine.org/blog/2015/9/21/save-lives-play-video-games56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:5600ab00e4b0ef8db7873f02A few years back we posted about about a protein folding video game that kicked off this movement to crowdsource solutions to complex problems. This new game “Malariaspot” will hopefully show how powerful collaborative energy can be when harnessed effectively.  A few years back we posted about about a protein folding video game that kicked off this movement to crowdsource solutions to complex problems. This new game “Malariaspot” will hopefully show how powerful collaborative energy can be when harnessed effectively.  Here’s what they say:

The Malariaspot game is a kick-off proof-of-concept experiment, which is part of a larger vision devoted to:

  • The establishment of a global specialized task force of remote gamers/workers able to perform on-line malaria diagnosis (and potentially other diseases).
  • The development of new on-line games powered by artificial intelligence engines able to diagnose and minimize the time required get a perfect parasite count.
  • Developing a microscopy-in-a-mobile-phone system for telediagnosis, allowing data transfer directly from field workers and health centers to the Malariaspot platform for rapid diagnosis.
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Save Lives. Play Video Games?
Unforseen Vaccine EffectsNewsEmily MagillWed, 12 Mar 2014 20:00:00 +0000http://www.memedicine.org/blog/2015/9/21/unforseen-vaccine-effects56005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:5600abf8e4b0e84b84f254c8An interesting paradigm is developing in the vaccine literature between specific and non-specific effects of vaccination. Specific vaccine effects  give disease protection and are independent of the order in which vaccines are given. Non-specific effects refer to the effects a vaccine might have on the overall immune system, which seems to depend on the order of vaccination.SAGE Advice

An interesting paradigm is developing in the vaccine literature between specific and non-specific effects of vaccination. Specific vaccine effects give disease protection and are independent of the order in which vaccines are given. Non-specific effects refer to the effects a vaccine might have on the overall immune system, which seems to depend on the order of vaccination.

Studies have suggested that mortality due to infection decreases when the most recent vaccine includes a living, attenuated virus and that mortality actually increases when the most recent vaccination is inactivated. Something about an immune response to a living entity seems to trigger a boost to the immune system.

In March of 2013, after several studies published evidence of non-specific effects of live vaccines, the World Health Organization (WHO) called together a Strategic Advisory Group of Experts (SAGE) working group to “review the evidence concerning the possible non-specific effects of vaccines included in the routine infant immunization schedule.”

Findings from Denmark

In addition to reviewing literature for the WHO, one of these SAGE Working Group members, Christine Stabell Benn, MD, PhD, has been busy working on her own studies of non-specific vaccine effects. She and her colleagues just published a study in the JAMA comparing hospital admittance for any infections between two cohorts of children.  One cohort received the vaccination regimen for live measles, mumps, rubella (MMR) as the most recent vaccine, while the other cohort received inactivated DTaP-IPV-Hib as their most recent vaccine. 

Benn and her colleagues found that children who had received the live MMR vaccine most recently had less hospital visits for infection than the children who had received inactivated DTaP-IPV-Hib.

Implications

If this effect is reproducible in other high-income communities, there is a chance that the SAGE Working Group will be able to recommend changes in vaccine policy that foster better patient outcomes. For high-income communities, this could mean less infections, less antibiotics, and less money spent on care. For low-income communities, it could be the difference between life and death.

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Unforseen Vaccine Effects
Insurable but UninsuredOpinionEmily MagillThu, 06 Feb 2014 18:57:00 +0000http://www.memedicine.org/blog/2016/1/15/insurable-but-uninsured-156005747e4b049a21c05edd6:56005a62e4b09bf305186b6e:56994107fd5d08aedf1b23c2The Affordable Care Act (ACA), known affectionately as Obamacare, promises to insure more, spend less, and achieve better health for all.The Affordable Care Act (ACA), known affectionately as Obamacare, promises to insure more, spend less, and achieve better health for all.

As one of many medical students who takes care of the uninsured, I have been brainstorming ways to help our patients enroll in New York’s health care exchange. What hadn’t occurred to me is that our patients might opt for our free student-run clinic services instead of coverage under the ACA.

As a result, clinics are faced with a difficult question – do they accept patients who are eligible for insurance under a newly expanded Medicaid or subsidized private programs but nonetheless opt out and choose free clinics for treatment? This is an ethical challenge compounded by the limitations of volunteer staff, one-time donations, and philanthropic grant-based funding.

Some clinics consider their limited resources and decide no, that they ought to turn away the patients that are insurable but uninsured. If a clinic can only make appointments for 10 patients per week, should it not reserve those spots for patients who have no other option? The large population of undocumented Americans is one of the groups who still need health services outside of the ACA.

It’s important to understand that turning away patients does not guarantee that patients will indeed enroll in the ACA or Medicaid. Instead, it is entirely plausible that many will go untreated and progress to more serious conditions. This is particularly dangerous for our diabetics who need support in reducing their risk of heart attacks, strokes, or deadly diabetic comas.

After discussing this issue with fellow clinic leaders, we decided that our free clinic will not turn away a patient who believes that we are their best option for health care. The ACA has enormous potential, but there is still substantial progress to be made in terms of coverage. Ultimately, we cannot, in good conscience, force our patients into a program that healthcare providers like us struggle to understand.

When our volunteers ran a survey for the month of December, we learned that 2/3 of our own patients hadn’t even heard of the ACA. According to the latest polls, more than 40% of Americans didn’t know that states had the opportunity to expand Medicaid coverage to more low-income, uninsured adults.

This issue goes beyond finances or legalities. It goes back to the reason why our clinics were created in the first place – to fill the gap between patient needs and the realities of our health care system. To close the door on our patients who have grown with us over the years would only perpetuate a failed mentality of our healthcare system; one that favors independence over collaboration. Our commitment as student practitioners is to work alongside our patients as they learn to take control of their own health.

As the ACA health exchanges evolve, our clinic will offer support for those who are eligible for federal programs but choose our services in the meantime. We will partner with them to address their concerns with the ACA, provide individualized education, and empower them to make decisions about how and where they receive care.

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