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Science Policy Around the Web – April 4, 2017

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By: James Taylor, PhD

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Research Funding

NIH Research Grants Yield Economic Windfall

Assessing the social and economic benefits of basic research – research conducted with no clear medical or financial goal in mind – has is often tricky with the former being philosophical in nature whilst the later sometimes coming years later from unexpected angles. A classic example of this process is the polymerase chain reaction (PCR), which was built on basic research on DNA replication in bacteria from hot springs published years before its invention.  Critics of publicly funded research often take studies out of context in order to ridicule them, such as Sarah Palin’s infamous “fruit flies” comment.

A recent analysis of the economic effects of the National Institutes of Health (NIH) funding has shone light on the economic benefits of basic research. Danielle Li and colleagues found that although 8.4% of NIH grants between 1980 and 2007 led directly to patents, 30.8% produced a scientific article which was later cited in a commercial patent for a drug, device or other medical technology. This demonstrates an enormous but indirect benefit of publically funded research. Furthermore, when the studies were broken down into basic or applied (research with a stated medical or commercial goal) they found no difference between the two in terms of how likely they were to be cited in a patent. This should give funding bodies pause for thought, as it calls into question their growing emphasis on applied research.

Taking into account the indirect effects of NIH funded research, the authors estimate that every $1 in NIH funding returns $1.40 in drug sales. This report is timely with proposed budget cuts for science funding looming large in the horizon, and exposes such cuts as sheer economic folly. (Elie Dolgin, Nature News)


HIV Infections are Spiking Among Young Gay Chinese

Recent surveys of HIV infections in China have shown a worrying spike in HIV infections among young gay and bisexual men, and have sparked the implementation of a broad 5-year plan to raise awareness and boost research into new treatments by the country’s ruling State Council. In the early 2000s, HIV infections were most prevalent amongst drug users in China, but there has been a steady decrease in prevalence amongst this group. The increase in HIV infections amongst men who have sex with men (MSM) has bucked this trend, and instead has been rising at an alarming rate. The cause of this increase remains unknown, with researchers at the National Health and Family Planning Commission in Beijing and China Medical University in Shenyang rather hopelessly suggesting that it was “possibly due to several unidentified and yet unaddressed risky sexual behaviors”.

China has previously mounted an effective response to the initial HIV epidemic by providing free antiretroviral to all HIV patients. This does little good, however, if you are afraid to admit you have HIV because it may out you as gay or bisexual. Despite recent improvements in LGBT rights and growing acceptance of LGBT people among the younger generation, being LGBT in China still carries with it significant stigma. This stigma, along with that of having HIV, may be causing young men to avoid seeking help out of fear. To reach out to gay men who may be at risk, the government and concerned nongovernmental organizations are working on novel outreach programs, such as working with dating apps popular with young gay and bisexual men to spread HIV awareness. The director of the Chinese Centre for Disease Control (China CDC), Wu Zunyou, has proposed increasing the availability of HIV self-test kits and pre-exposure prophylaxis medications, both of which would help those at risk whilst lessening the pressure from social stigma. (Kathleen McLaughlin, Science)

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April 4, 2017 at 10:00 am

Science Policy Around the Web – November 15, 2016

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By: Sarah Hawes, PhD

Source: PHIL


Florida voters weigh in on GM mosquito releases: What are the issues?

Concern over mosquito-borne Zika virus arriving in the United States this year spurred rapid allocation of resources toward identifying solutions. Clinical trials are just beginning for a traditional, attenuated vaccine while parallel efforts include research into injecting small DNA segments to effectively vaccinate by engaging a patient’s own cells to produce harmless, Zika-like proteins. However the risk of severe birth defects in infants born to Zika infected mothers is a powerful incentive for expediency. One answer exists in the use of genetically modified (GM) mosquitos to reduce vector number by breeding them in the wild. In August, the Food and Drug Administration (FDA) agreed for the first time to release of GM mosquitoes in the U.S.

The GM mosquitos in question are almost exclusively non-biting males of the Zika vector species Aedes aegypti, modified by British biotech company Oxitec, to carry a gene that prevents their offspring from reaching sexual maturity. Oxitec has used similar techniques successfully since 2009 in the Cayman Islands, Malaysia, Brazil, and Panama. A document prepared by the FDA Center for Veterinary Medicine examines myriad concerns, and determines program risks to be negligible. It includes ecosystem reports showing lack of predators reliant on the invasive Aedes aegypti, and explains that no recognized method exists for the genome-integrated transgene to impact or spread among other species. However a small percentage of GM mosquitos survive to adulthood and could transfer modified genes (or transgene resistance) to next-generation Aedes aegypti. In addition, some fear that population reduction among one disease-carrying mosquito species will make way for another, such as Aedes albopictus, which is also capable of carrying Zika, Dengue, and Chikungunya.

On Election Day, the final word on whether or not to release Oxitec GM mosquitos was given to voters living in the proposed release-site in the small peninsula neighborhood of Key Haven, Florida, and in surrounding Monroe County. Countywide, 58 percent of voters favored release. Within Key Haven, 65 percent opposed it. Following this divide, the decision now rests with Florida Keys Mosquito Control Board. (Kelly Servick, Science Insider)

HIV Vaccine

Controversial HIV vaccine strategy gets a second chance

The first participants in a $130 million HIV vaccine study, funded primarily by the National Institute of Allergy and Infectious Diseases (NIAID) and the Bill & Melinda Gates Foundation, received injections last week in South Africa. The study is a modified repetition of a study conducted in Thailand seven years ago that used nearly three times the number of participants and reported a modest 31.2% risk reduction through vaccination. In a nation with 6 million HIV positive persons, this would still be valuable if reproduced, but there is concern that alterations in the vaccine intended to boost efficacy could have the opposite effect.

No mechanism has been found for the vaccine’s efficacy in Thailand, making it hard to improve on. In hopes of extending the duration of protection, twice the amount of an HIV surface protein will be given. A canary-pox virus carrying pieces of HIV virus common in Thailand seven years ago (targets on which to hone the body’s immunity) has instead been loaded with strains common in South Africa. Finally, a stronger immune stimulant, or “adjuvant,” is included in the injection. However, in May, a study by National Cancer Institute vaccine researcher Genoveffa Franchini found that monkeys were protected from HIV by the old but not by the new adjuvant. Franchini suggests that the new adjuvant may even leave vaccinated persons more susceptible to infection. The South Africa study leader Glenda Gray says that Franchini makes a “compelling” argument for adding a group to repeat use of the old adjuvant, if more money can be found.

The enormity of South Africa’s AIDS epidemic (18% of global cases) compels empathy for the perspective held by Gray, who said, “Someone has to put their stake in the ground and have the courage to move forward, knowing we might fail.” At the same time one would hope that the use of $130 million in HIV research funds is being fueled more by quality medical science than by desperation and action-bias. (Jon Cohen, Science Magazine)

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November 15, 2016 at 9:45 am

Science Policy Around the Web – July 26, 2016

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By: Ian McWilliams, Ph.D.

photo credit: Newport Geographic via photopin cc

Infectious Diseases

Research charities help marry two major South African HIV/TB institutes

Two institutes, the Wellcome Trust and the Howard Hughes Medical Institute (HHMI), have announced that they are joining efforts in to fund the fight against HIV and Tuberculosis (TB) in South Africa. South Africa has the largest population infected with HIV. Because TB thrives in HIV-infected individuals, South Africa is experiencing a co-epidemic that has been challenging to battle. This collaboration will mark the first time that HHMI and The Wellcome Trust have worked together on a global health institution.

The new Africa Health Research Institute combines the Africa Centre for Population Health’s detailed population data gathered from over 100,000 participants with basic laboratory science and medical research of the KwaZulu-Natal Research Institute TB-HIV (K-RITH). Together the organization will work towards eliminating HIV and TB by training African scientists and will “link clinical and laboratory-based studies with social science, health systems research and population studies to make fundamental discoveries about these killer diseases, as well as demonstrating how best to reduce morbidity and mortality.” Projects funded by the institute include maintaining the longest running population-based HIV treatment as prevention (TasP) trial in Africa and using genomics to study drug resistant TB.

The organization is funded by a $50 million grant from The Wellcome Trust that is renewable over the next five years. Additionally, HHMI has already spent $40 million for the construction of new facilities, including a new biosafety level 3 laboratory that is designed to handle dangerous pathogens. These new efforts aim to apply scientific breakthroughs to directly help the local community. Deenan Pillay, the director of the new institute, has expressed his support of the organization’s mission by stating “There’s been increasing pressure and need for the Africa Centre not just to observe the epidemic but to do something about it. How long can you be producing bloody maps?” (Jon Cohen, ScienceInsider)

Scientific Reproducibility

Dutch agency launches first grants programme dedicate to replication

While a reproducibility crisis is on the minds of many scientists, the Netherlands have launched a new fund to encourage Dutch scientists to test the reproducibility of ‘cornerstone’ scientific findings. The €3 million fund was announced on July 19th by the Netherlands Organisation for Scientific Research (NWO) and will focus on replicating work that “have a large impact on science, government policy or the public debate.”

The Replication Studies pilot program aims to increase transparency, quality, and completeness of reporting of results. Brian Nosek, who led studies to evaluate the reproducibility of over 100 reports from three different psychology journals, hailed the new program and stated “this is an increase of infinity percent of federal funding dedicated to replication studies.” This project is the first program in the world to focus on the replication of previous scientific findings. Dutch scientist Daniel Lakens further stated that “[t]his clearly signals that NWO feels there is imbalance in how much scientists perform replication research, and how much scientists perform novel research.” The NWO has stated that it intends to include replication in all of its research programs.

This pilot program will focus both on the reproduction of findings using datasets from the original study and replication of findings with new datasets gathered using the same research protocol in the original study. The program expects to fund 8-10 projects each year, and importantly, scientists will not be allowed to replicate their own work. The call for proposals will open in September with an expected deadline in mid-December. (Monya Baker, Nature News)

Health Care Insurance

US Sues to block Anthem-Cigna and Aetna-Human mergers

United States Attorney General Loretta Lynch has announced lawsuits to block two mergers that involve four of the largest health insurers. Co-plaintiffs in the suits include eight states, including Delaware, Florida, Georgia, Illinoi, Iowa, Ohio, Pennsylvania, Virginia, California, Colorado, Connecticut, Main, Maryland, and New Hampshire, as well as the District of Columbia. The lawsuits are an attempt by the Justice Department to block Humana’s $37 billion merger with Aetna and Anthem’s $54 billion acquisition of Cigna, the largest merger in the history of health insurers. The Justice Department says that the deals violate antitrust laws and could mean fewer choices and higher premiums for Americans. Antitrust officials also expressed concern that doctors and hospitals could lose bargaining power in these mergers.

Both proposed mergers were announced last year, and if these transactions close, the number of national providers would be reduced from five to three large companies. Furthermore, the government says that Anthem and Cigna control at least 50 percent of the national employer-based insurance market. Lynch further added that “competition would be substantially reduced for hundreds of thousands of families and individuals who buy insurance on the public exchanges established under the Affordable Care Act.” The Affordable Care Act (ACA) aimed to encourage more competition between insurers to improve health insurance options and keep plans affordable. The Obama administration has closely watched the health care industry since the passing of that legislation and has previously blocked the mergers of large hospital systems and stopped the merger of pharmaceutical giants, such as the proposed merger of Pfizer and Allergan.

Health insurers argue that these mergers are necessary to make the health care system more efficient, and would allow doctors and hospitals to better coordinate medical care. In reaction to the announcement by the Justice Department, Aetna and Humana stated that they intend to “vigorously defend” the merger and that this move “is in the best interest of consumers, particularly seniors seeking affordable, high-quality Medicare Advantage plans.” Cigna has said it is evaluating its options. (Leslie Picker and Reed Abelson, New York Times)

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July 26, 2016 at 11:00 am

Science Policy Around the Web – February 12, 2016

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By: Rebecca A. Meseroll, Ph.D.

Zika research funding

Obama requests $1.8 billion in emergency funds to fight Zika

President Obama issued a statement of intent to request $1.8 billion from Congress to develop resources to combat the spread of Zika virus both internationally and domestically.  Zika, which is transmitted by the Aedes aegypti mosquito, has spread rapidly around Central and South America, the Caribbean, and the Pacific Islands in the past year, and is an emerging public health threat, especially due to its possible link with congenital microcephaly, a severe birth defect, in children born to women infected with the virus during their pregnancy.  The funds requested by the president would be used for a variety of purposes in an aggressive effort to contain the spread of the virus, including mosquito control, research on the virus and a potential vaccine against it, public education campaigns, and support personnel and equipment for areas where the outbreak is ongoing.  Congress will have to decide whether to grant the funds, which would be part of the 2017 budget, later this year.  While there is much to be done to minimize the impact of Zika, health officials indicate there is no cause for alarm about large-scale spread of the virus in the United States at present, but women who are pregnant or considering becoming pregnant are advised to use caution when planning travel to countries affected by Zika. (Jon Cohen, ScienceInsider and Mark Landler, The New York Times)

Climate change policy

Supreme Court stays climate change regulations

The Clean Power Plan, developed by the U.S. Environmental Protection Agency (EPA) at President Obama’s behest last year, sought to reduce carbon dioxide emissions from power plants by 32% compared to 2005 levels.  The EPA’s rules would require states to create their own plans, due to the agency by September of this year, detailing how they would reduce emissions beginning in 2022.  This week, however, the US Supreme Court granted a request put forth by many states and power companies to put the regulations on hold on the grounds that they are outside of the purview of the EPA.  Thus the regulations are set up to endure a lengthy legal battle, as the case will not come up in appeals court until June, after which it will likely be appealed to the Supreme Court, who would not hear the case until 2017.  Although the Supreme Court did not give its reasons for granting the stay, experts suggest that the Court may be telegraphing its wariness about the legality of the regulations by making this decision before the case has gone through a lower court.  The Obama administration remains confident and environmentalists hopeful that the regulations will hold up in court, however it may be necessary in the future for Congress to pass climate change legislation before progress can actually be made. (Jeff Tollefson, Nature and Robert Barnes and Steven Mufson, The Washington Post)

HIV and organ transplantation

First HIV-positive organ transplants to occur in the United States

Years of advocacy led to the passage of the HIV Organ Policy Equity Act in 2013, which lifted a ban on research into organ donations between HIV-positive individuals, and now the life-saving promise of the law is about to come to fruition. Doctors at Johns Hopkins received permission from the United Network for Organ Sharing to perform the first kidney and liver transplants between HIV-positive donors and recipients in the US, and they are prepared to conduct the procedures as soon as the first patients are ready. Johns Hopkins will be the first in the world to perform liver transplants between an HIV-positive donors and HIV-positive recipients, however doctors in South Africa have had success with kidney transplants of this kind since 2008.  It has been estimated that organs from more than 500 potential HIV-positive deceased donors have gone unused each year because of previous prohibitions, thus this new source of HIV-positive donor organs for HIV-positive recipients is expected to improve wait-times for all patients hoping for an organ to become available.  The current HIV-positive transplants will utilize only organs from deceased donors, as more research must be done to determine the outcomes of kidney donation for HIV-positive patients. (Daniel Victor, The New York Times and Ariana Eunjung Cha, The Washington Post)

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February 12, 2016 at 9:00 am

Science Policy Around the Web – October 6, 2015

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By: Eric Cheng, Ph.D.

Photo credit link: pixabay

HIV drug policy

Treat all people living with HIV, offer antiretrovirals as additional prevention choice for people at “substantial” risk

A new policy change recommended by the World Health Organization (WHO) will remove previous limits which suggested that patients wait until the disease progresses instead of treating HIV infection when first detected.  The previous WHO guidelines limited treatment to people whose immune cell counts had fallen below a certain threshold. This new change could prevent more than 21 million deaths and 28 million new infections by 2030, which is in line with the United Nation’s aim of ending the AIDS epidemic in the same year.

“Everybody living with HIV has the right to life-saving treatment. The new guidelines are a very important step towards ensuring that all people living with HIV have immediate access to antiretroviral treatment,” said Michel Sidibe, executive director of UNAIDS. However, this move would lead to an increase in demand for antiretroviral therapy, which generally are given as a three-drug cocktail aimed at reducing the risk of the virus developing resistance. This increase in demand will lead to an increase in required financial support from both charities and governments.  Currently, almost $22 billion is currently spent on AIDS in poor and middle-income countries, half of it contributed by donors, according to UNAIDS. Even before the new guidelines were announced, the necessary funding was predicted to rise to $32 billion by 2020. “Now the question becomes how quickly will governments take up this recommendation,” Matthew Kavanagh, senior policy analyst for the U.S.-based Health Global Access Project. (WHO News Release)

NIH Leadership

Selection of Dr. Michael Lauer as the Deputy Director for Extramural Research, NIH

Michael S. Lauer, M.D, the Director of the Division of Cardiovascular Sciences (DCVS) at the National Heart, Lung, and Blood Institute (NHLBI) has been selected to head the extramural research at the National Institutes of Health (NIH). As the director of DCVS, Dr. Lauer provided leadership in basic, clinical, population, and health services research on the causes, prevention, and treatment of cardiovascular diseases in one of the largest extramural divisions at NIH with a $1.7 billion portfolio. Now as director of the Office of Extramural Research, Dr. Lauer will oversee policies and guidelines for extramural research administration within NIH and in the biomedical research community.

Dr. Lauer will be replacing Sally Rockey, who resigned in June to accept a position at a new nonprofit called the Foundation for Food and Agriculture Research. (Francis S. Collins, NIH)

International Scientific Community

Scientist says researchers in immigrant-friendly nations can’t use his software

A German scientist, Gangolf Jobb, writes that he will be revoking the TREEFINDER licenses of researchers in Germany, Austria, Belgium, Denmark, France, the Netherlands, Sweden, and the United Kingdom on October 1 because of the countries’ immigration policy. He wrote “Immigration to my country harms me, it harms my family, it harms my people. Whoever invites or welcomes immigrants to Europe and Germany is my enemy,” and added, “Immigration unnecessarily defers the collapse of capitalism, its final crisis.”

TREEFINDER is a computer program that computes phylogenetic trees from molecular sequences. It is commonly used to build diagrams to show the most likely evolutionary relationship of various species. Fortunately there are alternatives to this software, which has not been updated since March of 2011. Researchers in the United States had already been banned from using the program in February to protest “a small rich elite there that misuses the country’s power to rule the world. The USA is our worst enemy.” (Kai Kupferschmidt, ScienceInsider)

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October 6, 2015 at 9:00 am

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Science Policy Around the Web – May 29, 2015

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By: Julia Shaw, Ph.D.

Pills prepared for H.I.V. patients in Thailand. Credit: Taylor Weidman/Getty Images

Global Health – Treatment for HIV

H.I.V. Treatment Should Start at Diagnosis, U.S. Health Officials Say

The Strategic Timing of Antiretroviral Treatment (Start) trial, the largest clinical trial evaluating the benefits of early antiretroviral treatment for HIV, was ended prematurely after interim analyses revealed a 53% reduction in AIDS-related death or illness in subjects who began taking antiretroviral drugs at diagnosis compared to those who started only after their CD4 T cell counts in blood dropped below 350 cells/ml or after succumbing to an AIDS-related event like infection with an opportunistic pathogen. Although the news is not a surprise to those working in the HIV field, according to the director of the National Institute for Allergy and Infectious Disease, Dr. Anthony Fauci, for those who may have been exposed to the virus it is “another incentive to seek out testing and start therapy early, because you will benefit.” Additionally, those on a consistent regimen of anti-HIV drugs are over 90% less likely to infect others.

As of 2014, only 13 million out of an estimated 35 million infected with HIV were on antiretroviral treatment. Experts estimate identifying and treating all HIV positive individuals would cost at least three-times the amount currently donated through organizations like The Global Fund to Fight AIDS, Tuberculosis and Malaria and the President’s Emergency Plan for AIDS Relief. Aside from the cost of drugs, in the United States — where only 30% of those infected take antiviral drugs consistently — many still fear drug side-effects yet most modern formulations do not have the harsh side-effects of the earlier generation of drugs. When the study began in 2009, guidelines set forth by the Centers for Disease Control and Prevention recommended starting therapy when a patient’s CD4 count fell below 500. The World Health Organization suggested waiting until the count fell below 350. This study provides strong evidence that in terms of lives saved, earlier treatment is clearly effective. (Donald G. McNeil Jr., The New York Times)

The Environment – Clean Water

President Obama asserts power over small waterways

The Environmental Protection Agency (EPA) and Army Corps of Engineers have finalized their proposal for the controversial “waters of the United States rule”, a rule designed to clarify which waterways are protected by the Clean Water Act. Past Supreme Court decisions have questioned whether small tributaries, streams, and wetlands were subject to the regulations of the Clean Water Act, prompting the construction of this new rule. Republicans and like-minded businesses fear excessive federal involvement and regulation of minor waterways, ditches and puddles. However Gina McCarthy, head of the EPA, maintains the rule will “protect the streams and wetlands that one in three Americans rely on for drinking water . . . This rule will make it easier to identify protected waters and will make those protections consistent with the law as well as the latest peer-reviewed science.” McCarthy further contends the federal government’s jurisdiction would increase less than 3% and that the rule does not hamper agriculture or remove existing exemptions for farmers, ranchers, or foresters, frequently the most vocal opponents to the rule. Despite efforts in both the House and Senate to overturn the rule, President Obama stands firmly in support of the new regulations stating, “Too many of our waters have been left vulnerable to pollution.” (Timothy Cama, The Hill)

International Funding for the Sciences

Russian foundation tarred with ‘foreign’ label

Russia’s foreign agent law was enacted in 2012, targeting nongovernmental organizations concerned with human rights and free elections. The law forces burdensome reporting requirements and necessitates that any materials produced by the organization indicate that a foreign agent produced them. On Monday, the Russian government identified the Dynasty Foundation, a nonprofit based in Moscow and one of the country’s leading science foundations supporting science education and early-career scientists, as a “foreign agent.” The ruling was made despite a petition organized by 28 members of the Russian Academy of Sciences (RAS) arguing that the foundation’s work is fully transparent and “has nothing to do with advocacy of foreign states’ interests.” Funding for the foundation is heavily dependent on its founder, Dmitry Zimin, a Russian telecom tycoon who regularly transfers funds, some $10 million per year since its inception in 2002, from his offshore accounts to the foundation. President Putin’s spokesperson, Dmitry Peskov, stated that if Dynasty “gets money from abroad, then it is a foreign agent” which is subject to the foreign agent law. In response, Zimin has threatened to stop funding the institution. A meeting of Dynasty officials set for June 8th will decide the foundation’s future. (Vladmir Pokrovsky, Science Insider)

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May 29, 2015 at 9:00 am

The remarkable efficacy of HIV pre-exposure prophylaxis could change the trajectory of the HIV epidemic

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By: Elisavet Serti, PhD

The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that in 2013, there were 35 million [33.2–37.2 million] people living with HIV globally, despite widespread awareness of the modes of transmission and the protective benefits of condom use. As of June 2014, only 13.6 million of these people living with HIV had access to antiretroviral therapy. The most alarming statistic is that 19 million of these people do not know their HIV-positive status, according to a new report by UNAIDS. It appears that individuals at risk for HIV infection are still participating in risky sexual behavior and that more education about HIV and AIDS prevention is crucial.

In the United States, complacent attitudes among young adults towards HIV/AIDS infection are on the rise, in part, due to increasingly effective therapies that improve the disease’s manageability. The fact that HIV/AIDS is no longer an automatic “death sentence” could possibly explain lax attitudes among young people when it comes to safe sex practices to avoid infection, such as condom use. As such, the approval of Truveda – a daily, oral pill indicated for pre-exposure prophylaxis (PrEP) – by the Food and Drug Administration (FDA) in 2012 was hailed as a victory by the medical community. Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials. A PrEP indication means that Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing. In an FDA press release, Truvada was described as “the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for PrEP in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.” The FDA Commissioner, Margaret A. Hamburg M.D., marked its approval as “an important milestone in our fight against HIV.”

When HIV researchers showed that people likely to be exposed to HIV could significantly decrease their risk of infection by taking one pill, many researchers immediately raised doubts about the pill’s real-world efficiency. Some scientists and health care workers rejected PrEP stating that this strategy could potentially undermine the traditional and still necessary ways of anti-HIV protection, such as safe-sex practices like condom use. Additionally, some at-risk people have not used PrEP because they fear it will brand them as promiscuous or reckless. Young, single women appear especially reluctant to use the drug, again because of the fear of a social stigma. The pill has also raised controversy in the gay community. The husband of an HIV-positive man who is taking PrEP regularly and remains HIV-negative said in a recent interview, “there’s a real stigma against this drug. Any young gay man that considers using Truvada is viewed as somebody who must be putting himself at great sexual risk for HIV.” It has been shown that men who have sex with men (MSM) carry a disproportionate burden of being infected with HIV compared with general population samples from low- and middle-income countries in the Americas, Asia, and Africa. MSM is a term coined in 1994 to reduce stigma against gay, bisexual, transgendered, and self-identified heterosexual men who engage in sex with other men, by describing behaviors rather than social or cultural identities. The odds for HIV infection in MSM are elevated across prevalence levels of MSM-associated HIV infection by country and decrease as general population prevalence increases, but remain 9-fold higher in medium-high prevalence settings. MSM from low- and middle-income countries are in urgent need of prevention and care, and appear to be both understudied and underserved.

Based on studies conducted primarily outside the United States of both high-risk men who have sex with men and heterosexual couples, Truvada has been shown to reduce the risk of acquiring HIV infection by more than 50% in several subgroups of patients when used daily in combination with a comprehensive HIV prevention strategy, including safer sex practices. The key factor for its effectiveness is the adherence to daily administration. Robert Grant, a top HIV researcher at the Gladstone Institutes and University of California at San Francisco and one of the pioneers of the PrEP approach, led a pivotal study of PrEP in 2010 with remarkable efficiency results. In this study, Truvada cut the rate of new infections in men who have sex with men and transgender women by 92% if they took the pill daily. Unfortunately, half of the participants failed to comply with the daily administration rules, which reduced the overall efficiency to 44%. A follow-up study included a large number of heterosexual “discordant” couples, in which only one partner was infected, found that adherence was much better, yielding 75% protection. There has been a lot scientific controversy from the publication of these studies, with other research groups raising questions about the economic impact of this prevention strategy, the side effects (e.g., renal insufficiency), the potential emergence of drug resistance (in patients with HIV and hepatitis B virus infection), the chance of risk compensation (increased high-risk sexual behavior) of the uninfected recipients of PrEP, and the age difference between experimental groups of the study.

Dr. Grant has continued his PrEP research and published a modeling study of the San Francisco epidemic, in which only 31% of people at high risk of infection used the PrEP regimen at some point last year, showing again that the potential payoff of widespread PrEP could be huge. If 65% of these people used the PrEP regimen for 12 months, the number of annual new infections would be halved. That drop could double again by aggressive use of both PrEP and antiretroviral treatment. “We’re at a tipping point where PrEP was a proven concept of unknown applicability,” Grant stated in a recent Science article, “and what’s most exciting is we can now see that is feasible.”

Dr. Anthony Fauci, who has headed the National Institute of Allergy and Infectious Diseases since 1984 and was one of the leading researchers involved in developing antiretroviral therapy for HIV, stated that Truvada is “highly efficacious, in my mind easily over 90 percent if you adhere rigidly to it.” He was quick to add, in line with the guidelines from all the United States government agencies, that the use of Truvada should be purely a preventive measure, that it’s meant to augment the protection provided by condoms, not to replace them. Still, having one more tool to add to the arsenal against HIV/AIDS is a great step forward in combating the spread of this disease.

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April 8, 2015 at 9:00 am

Posted in Essays

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