Johnson & Johnson/Tibotec AIDS Drug Licenses Exclude Too Many Patients

Doctors Without Borders: "Licenses just agreed between three generic manufacturers and pharmaceutical company Tibotec, owned by Johnson & Johnson, will keep a promising new AIDS medicine out of the hands of many patients across the developing world, the international medical humanitarian organization Médecins Sans Frontières (MSF) said today. The licenses exclude many developing countries where Johnson & Johnson/Tibotec will likely charge high prices. Other precise restrictions introduced by the agreement must be scrutinized carefully.

"Tibotec has licensed production of the antiretroviral medicine rilpivirine to one South African and two Indian manufacturers, but has limited the geographic scope of the licenses such that all of Latin America, Central Asia and most Caribbean and South East Asian countries will not be able to receive generic versions of the medicine. Given the restrictive licensing, these countries may not be able to import generic versions from India even if they override patents in their countries through compulsory licenses."

Murder of Ugandan LGBT Activist David Kato

U.S. Secretary of State Hillary Clinton: "We are profoundly saddened by the loss of Ugandan human rights defender David Kato, who was brutally murdered in his home near Kampala yesterday. Our thoughts and prayers are with his family, friends, and colleagues. We urge Ugandan authorities to quickly and thoroughly investigate and prosecute those responsible for this heinous act.

"David Kato tirelessly devoted himself to improving the lives of others. As an advocate for the group Sexual Minorities Uganda, he worked to defend the rights of lesbian, gay, bisexual, and transgender individuals. His efforts resulted in groundbreaking recognition for Uganda's LGBT community, including the Uganda Human Rights Commission's October 2010 statement on the unconstitutionality of Uganda's draft 'anti-homosexuality bill' and the Ugandan High Court's January 3 ruling safeguarding all Ugandans' right to privacy and the preservation of human dignity. His tragic death underscores how critical it is that both the government and the people of Uganda, along with the international community, speak out against the discrimination, harassment, and intimidation of Uganda's LGBT community, and work together to ensure that all individuals are accorded the same rights and dignity to which each and every person is entitled."

Global Fund: Misleading Corruption Report

by John S. James, Aidsnews.org

In the last few days hundreds of news stories have suggested that much or even most of the grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria have been lost to fraud. Most of the recent stories come from an Associated Press article published January 23 (see link below). Because of these stories, Germany suspended its payments to the fund pending investigation.

This is surprising because the Global Fund has been well known to be very aggressive in preventing or rooting out fraud, and in getting back money misused or stolen. And the issues matter because the Global Fund provides HIV or TB treatment to about 10 million people in poor countries, and malaria prevention to over 100 million -- most of whom would not otherwise get care.

Concerning the last few days' news, keep in mind:

(1) Almost all of the corruption information in the glut of stories in the last few days was discovered by the Global Fund itself, and published over a month ago (see the link below). The AP report and the hundreds of copycat stories in the last few days have echoed old information.

(2) The widely agreed figure of losses shown so far is just over $34 million (including "unsupported" expenses, which can be missing paperwork instead of corruption). This is serious, since money lost will result in unnecessary deaths. However, this represents about 0.3% of the money given out by the Global Fund, which appears to compare well with similar programs -- or with Washington, Wall Street, Europe, or anywhere else.

(3) If donors use these stories as an excuse to stop contributing to global health, millions of people will die as a result.

The Global Fund has done much better than other organizations in rooting out corruption, and is now being blamed for its own success in bringing problems to light.

Why the timing? Why a surge of hundreds of news stories in major media in 5 days, breathless with scandal but with little information except what the Global Fund itself published more than a month ago? Is it only coincidence that the right-wing plutocracy has chosen this time for a major worldwide assault against the poor and the middle class?

References

• The AP story, as it appeared in the Washington Post: http://www.washingtonpost.com/wp-dyn/content/article/2011/01/23/AR2011012302087.html
• For hundreds of other stories, visit http://news.google.com and search for:
  "Global Fund to Fight AIDS, Tuberculosis and Malaria" corruption
• The Global Fund document from which most of these stories came: http://www.theglobalfund.org/documents/board/22/BM22_OIG-EDJointCommunication_Statement_en.pdf
• For background, see short interview with Stephen Lewis, former UN envoy for HIV/AIDS in Africa, http://www.cbc.ca/world/story/2011/01/26/video-stephen-lewis-aid-fund-missing.html

Obama Barraged By Pot Questions For Upcoming YouTube Town Hall

Huffington Post: "President Barack Obama plans to take questions from YouTube viewers Thursday afternoon, and for the third time in as many years, the overwhelmingly most popular query involves the legalization of marijuana.

"Of the top 100 most popular questions as rated by YouTube users, 99 are about the drug war or pot. Of the next one hundred, 99 are again about drug policy. Somehow, two questions about clean energy made their way into the top 200. ...

"The major drug-policy reform organizations say they have had little to do with the popularity of the pot questions and that it has largely been a 'grassroots' response. The top question is from an official associated with the group Law Enforcement Against Prohibition, but the second- and third-most popular, judging by their YouTube pages, are clearly not connected to a mainstream advocacy group."

HIV Lipo Drug Egrifta Now Available; Financial Assistance Programs Open

POZ: "Egrifta (tesamorelin), the lipodystrophy treatment approved by the U.S. Food and Drug Administration (FDA) late last year, is now officially available to people living with HIV and their health care providers, according to announcements from EMD Serono. To expedite prescriptions and reimbursement, the company also described various services—including patient assistance and co-pay programs—now open to HIV-positive patients who need the drug."

CDC Issues Interim Guidance to Providers About PrEP

POZ: "Aside from the modest level of protection found overall, the study also revealed that in people who reported taking Truvada at least 90 percent of the time, the reduction in infections was 73 percent.

"In the interim guidance, published January 27 in the Morbidity and Mortality Weekly Report (MMWR), the CDC warns, however, that there are important caveats to the study results—limitations that many community members pointed out when the data were first published."

City of Hope team develops "smart bomb" to neutralize HIV

Pasadena Star-News: "'What I like about it is the fact that this isn't just something that happened overnight. Rossi and his team have been working on strategies to stop HIV replicating using these very cutting-edge technologies based on RNA.'

"In the past, she said, 'they've made nice, steady, incremental progress.'

"'Now, in this study, they show the latest actually works really well in the context of a live animal - which is a huge step.'"

Australia clean-needle program keeping HIV at bay

Reuters: "'There has never been a significant, generalized outbreak of HIV among people who inject drugs in this country,' Topp said.

"'What our results show is that in a country where needle and syringe programs were introduced early and on a widespread basis, HIV transmission never became a problem among injectors.'

"Topp told Reuters Health in an email that, based on other research, the 1 percent HIV rate is true of all injection-drug users in Australia, and not only those who use the needle and syringe programs.

"By contrast, an estimated 16 percent of injection-drug users in the United States are living with HIV, while in Russia that figure is 37 percent."

Unexpected Find Opens Up New Front in Effort to Stop HIV

News Room - University of Rochester Medical Center: "'The first cells that HIV infects in the genital tract are non-dividing target cell types such as macrophages and resting T cells' said Kim. 'Current drugs were developed to be effective only when the infection has already moved beyond these cells. Perhaps we can use this information to help create a microbicide to stop the virus or limit its activity much earlier.'

"Kim notes that a compound that targets rNTP already exists. Cordycepin in an experimental compound, derived from wild mushrooms, that is currently being tested as an anti-cancer drug. The team plans to test similar compounds for anti-HIV activity.

"'This significant breakthrough was unappreciated prior to our paper. We are now exploiting new anti-HIV drugs jointly based on this novel approach that are essentially not toxic and that can be used to treat and prevent HIV infections,' said Schinazi, who has developed several of the drugs currently used to treat HIV patients."

Federal Research Center Will Help Develop Medicines

NYTimes.com: "The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines."

Free online tool may help doctors make treatment decisions for HIV-positive patients with drug resistance

Aidsmap: "UK investigators have developed an online resource that can help doctors select the most effective combination of anti-HIV drugs for patients with extensive experience of antiretroviral therapy. Evaluated in two studies published in the January edition of AIDS Patient Care and STDs, suggestions made by the tool led to doctors changing their initial treatment decision in a third of cases. Physicians found the resource easy to use, and the majority said that they would consider using it in the future.

"An updated version of the resource, the HIV Treatment Response Prediction System (HIV-TRePS), is now freely available on the internet, and is based on a computer model that includes information gathered from 65,000 HIV-positive patients across the world."

ADAPs with Waiting Lists (5,387 individuals in 10 states*, as of January 13, 2011) (NASTAD)

NATAP, from NASTAD: "ADAPs with Waiting Lists (5,387 individuals in 10 states*, as of January 13, 2011) (NASTAD)
 
"As of January 13, 2011, there are 5,387 individuals on ADAP waiting lists in ten (10) states. From NASTAD
 
"ADAPs with Waiting Lists (5,387 individuals in 10 states*, as of January 13, 2011)
 
Arkansas: 19 individuals
Florida: 2,816 individuals
Georgia: 873 individuals
Louisiana: 583 individuals**
Montana: 19 individuals
North Carolina: 100 individuals
Ohio: 438 individuals
South Carolina: 341 individuals
Virginia: 197 individuals
Wyoming: 1 individual ...

*As a result of ADAP emergency funding, Hawaii, Idaho, Iowa, Kentucky, South Dakota, and Utah eliminated their waiting lists.
**Louisiana has a capped enrollment on their program. This number is a representation of their current unmet need."

Repealing the Affordable Health Care Act means woes for people with HIV - Washington DC HIV and AIDS | Examiner.com

Repealing the Affordable Health Care Act means woes for people with HIV - Washington DC HIV and AIDS: "Repealing the act would mean:

* No expansion of Medicaid which would assist people with HIV/AIDS with life-saving healthcare
* No added provisions such as high-risk pools and insurance exchanges.  Those who have no coverage or have been previously denied coverage (perhaps because of a pre-existing condition) may be continuously denied and will not be able to comparison shop for private health-insurance plans.
* The Medicare Part D drug benefit coverage gap (otherwise known as the donut hole) stays put. People living with HIV/AIDS will not be able to depend on state AIDS Drug Assistance Programs (ADAP) to help cover the cost of prescription drugs."

Mutation of HIV-1 Genomes in a Clinical Population Treated with the Mutagenic Nucleoside KP1461

Mutation of HIV-1 Genomes in a Clinical Population Treated with the Mutagenic Nucleoside KP1461: "Overall, many RNA virus populations, including HIV, appear to exist near the brink of survivability [12], [13], as agents that disrupt the delicately balanced networks described above – by increasing the frequency of mutations in the HIV genome by as little as <2-fold – cause viral extinction in cell culture [14]–[17]. Similarly, small increases in viral mutation frequencies have been shown to be associated with population collapse in other viral systems, including Vesicular Stomatitis, polio, Hepatitis C, Hantaan and foot-and-mouth disease [18]–[25].

"We are studying the use of first-in-class nucleotide analogs that are incorporated by reverse transcriptase without leading to chain termination, yet base pair ambiguously and thus cause mutations, with the goal of eventually pushing the viral quasispecies beyond the brink of survivability in vivo. We term this approach to HIV therapy as “viral decay acceleration” (VDA)."

Stroke rate is climbing in HIV-positive people

latimes.com: "They reported in the online edition of the journal Neurology that, in the general population, the incidence of stroke fell 7%, from 998,739 cases in the first year of the study to 926,997 cases in the final year. During the same time period, however, the incidence of stroke among HIV-positive people rose about 60%, from 888 cases to 1,425. Moreover, all of the increase was in ischemic stroke -- strokes caused by blood clots in the brain -- and none in strokes caused by bleeding."

U.S. study finds 129 million have health conditions

Reuters: "As many as 129 million Americans under age 65 have health problems that could hurt their ability to obtain health insurance or force them to pay higher premiums, a U.S. government study said on Tuesday."

New research examines how HIV infections occur on the molecular level

EurekAlert!: "The UK's National Physical Laboratory (NPL) with the University of Edinburgh and IBM's TJ Watson Research Center have published new research about the structure of an HIV-1 protein that could help to develop new drugs to stop the virus infecting healthy cells.

"The research provides a new insight into how the changes in structure of a small part of an HIV protein (a membrane proximal peptide) may alter the infection of the virus into healthy cells. The team was able to observe key changes in this part of the protein implicated in the early stages of the infection by using a combination of powerful experimental and computational tools. This is the first attempt to demonstrate that the inducible binding of the peptide with membrane-like surfaces can serve as a responsive molecular anchor underpinning HIV fusion to target cells. ...

"The team's journal article detailing this research was selected as the featured article in the January 2011 issue of the journal Physical Chemistry Chemical Physics – the Royal Society of Chemistry's premier forum for physical chemistry research."

Women Might Have More Favorable Blood Levels of Some HIV Drugs

POZ: "Mona Loutfy, MD, one of the study’s authors, reported that she and her colleagues found that the average minimum concentrations (Cmin) of at least two drugs—Viramune and Kaletra—were significantly higher than what has been found in previous studies in the general population, while minimum concentrations were lower than average in women taking Reyataz or Sustiva. The primary concern about blood levels is keeping them within a “therapeutic” range, whereby there is enough drug present to shut down HIV repliction almost entirely, but not so much that it increases the risk of side effects. The authors suggest, however, than maintaining a higher than average Cmin level, even within this therapeutic range, might confer a treatment advantage.

"Loutfy’s team also found, contrary to expectation, that the maximal concentrations (Cmax) of all four drugs was slightly lower than average in their study participants. A lower Cmax would, theoretically, predict fewer and less severe side effects in the women."

New Treatment Guidelines Published

January 10, 2011

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

What’s New in the Guidelines?

Key changes made to update the December 1, 2009, version of the guidelines are summarized below. Throughout the revised guidelines, significant updates are highlighted and fully discussed.

Introduction

The Panel emphasizes its recognition of the importance of clinical research in generating evidence to address unanswered questions related to the optimal safety and efficacy of antiretroviral therapy (ART). The Panel encourages both the development of protocols and patient participation in well-designed, Institutional Review Board (IRB)-approved clinical trials.

CD4 T-cell Count

The Panel recognizes that changes in CD4 cell count are seldom used in decision for ART changes in a patient on a suppressive ART regimen whose CD4 count is well above the threshold for opportunistic infection risk. In such patients, the Panel recommends that the CD4 count may be monitored less frequently, for example every 6 to 12 months (instead of every 3 to 6 months), unless there are changes in the patient’s clinical status, such as new HIVassociated clinical symptoms or initiation of treatment with interferon, corticosteroids, or anti-neoplastic agents (CIII).

Viral Load Testing

The Panel recognizes that low-level positive viral load results (typically <200 copies/mL) have been commonly reported with some viral load assays. For the purpose of patient monitoring, the Panel defines virologic failure as a confirmed viral load >200 copies/mL, which eliminates most cases of viremia caused by isolated blips or assay variability.

Drug-Resistance Testing

The Panel provides more specific recommendations on when to use genotypic testing to detect resistance to integrase strand transfer inhibitors (INSTIs).
• Because standard genotypic drug-resistance testing involves testing for mutations in the reverse transcriptase (RT) and protease (PR) genes, if transmitted INSTI resistance is a concern, providers may wish to supplement standard genotypic resistance testing with genotypic testing for resistance to this class of drugs (CIII).
• In persons failing INSTI-based regimens, genotypic testing for INSTI resistance should be considered to determine whether to include a drug from this class in subsequent regimens (BIII).

What to Start: Initial Combination Regimens for the Antiretroviral-Naïve Patient

Changes to the “What to Start” recommendations include the following:

• A regimen consisting of maraviroc (MVC) + zidovudine/lamivudine (ZDV/3TC) is now listed as an “Acceptable Regimen” because FDA approval of MVC for use in ART-naïve patients was based on the results of a randomized controlled trial using this regimen (CI).
• “MVC + tenofovir/emtricitabine (TDF/FTC)” and “MVC + abacavir (ABC)/3TC” have been added as “Regimens that may be acceptable but more definitive data are needed” (CIII).
• In response to a recent change to the Invirase® product label based on findings from a healthy volunteer study that reported significant PR and QT interval prolongations, ritonavir-boosted saquinavir (SQV/r)-based regimens have been moved from “Alternative PI-based Regimens” to “Regimens that are Acceptable but Should be Used with Caution.”

Hepatitis B (HBV)/HIV Coinfection

This section has been revised to provide more specific recommendations for management of HIV patients coinfected with HBV, including recommendations for patients with 3TC/FTC-resistant HBV infection and for patients who cannot tolerate TDF-based regimens.

Mycobacterium Tuberculosis Disease with HIV Coinfection

Based on recent randomized controlled trials showing survival and clinical benefits of starting ART earlier in treatment-naïve patients with active tuberculosis (TB) disease, the Panel provides the following recommendations on when to start ART in patients who are receiving treatment for active TB but are not yet on ART.
• All HIV-infected patients with diagnosed active TB should be treated with ART (AI).
• For patients with CD4 count <200 cells/mm3, ART should be initiated within 2–4 weeks of starting TB treatment (AI). • For patients with CD4 count 200–500 cells/mm3, the Panel recommends initiating ART within 2–4 weeks, or at least by 8 weeks after commencement of TB therapy (AIII). • For patients with CD4 count >500 cells/mm3, most panel members also recommend starting ART within 8 weeks of TB therapy (BIII).

Adverse Effects of Antiretroviral Agents

A new table format provides clinicians with a list of the most common and/or severe known antiretroviral (ARV)-associated adverse events listed by ARV drug class.

Additional Updates

The following sections and their relevant tables have also been updated:
• Coreceptor Tropism Assays
• Treatment Goals
• Initiating Antiretroviral Therapy in Treatment-Naïve Patients
• What Not to Use
• Virologic and Immunologic Failure (previously titled “Management of Patients with Antiretroviral Treatment Failure”)
• Regimen Simplification
• Exposure-Response Relationship and Therapeutic Drug Monitoring for Antiretroviral Agents
• Acute HIV Infection
• HIV and Illicit Drug Users (with new Table)
• HIV-2 Infection
• Drug Interactions (and Tables)
• Drug Characteristics Tables (Appendices)

Distribution of Antiretroviral Treatment Through Self-Forming Groups of Patients in Tete Province, Mozambique

JAIDS Journal of Acquired Immune Deficiency Syndromes: "Discussion: The Community ART Group model was initiated by patients to improve access, patient retention, and decongest health services. Early outcomes are highly satisfactory in terms of mortality and retention in care, lending support to such out-of-clinic approaches." [full text free]

Effects of in Utero Antiretroviral Exposure on Longitudinal Growth of HIV-Exposed Uninfected Infants in Botswana

JAIDS Journal of Acquired Immune Deficiency Syndromes: "Conclusions: Lower weights in HAART-exposed uninfected infants at birth were rapidly corrected during the first 6 months of life."

Identification of PD-1 as a Unique Marker for Failing Immune Reconstitution in HIV-1–Infected Patients on Treatment

JAIDS Journal of Acquired Immune Deficiency Syndromes: "In this study, we have analyzed PD-1 expression on CD4 and CD8 T cells in patients with poor immune reconstitution despite successful highly active antiretroviral therapy. We found that T cells of such patients express significantly higher levels of PD-1 than patients who had normal recovery of CD4 cells after treatment. In contrast, failing immune reconstitution was not associated with the expression of activation markers, indicating that PD-1 is a unique marker for failing immune reconstitution despite viral suppression."

Lipitor and Crestor Are Better Than Pravachol for HIV Treatment-Related Cholesterol Problems

POZ: "Lipitor (atorvastatin) and Crestor (rosuvastatin)—two drugs in the statin family—were about twice as likely as the statin Pravachol (pravastatin) to help HIV-positive people get their cholesterol and triglyceride levels within the desired range. These data were published online December 28 in Clinical Infectious Diseases."

New Study in San Francisco Aims to Improve HIV Care for Aging Population

POZ: "Researchers at the University of California in San Francisco (UCSF) have launched a study to discover the best comprehensive care methods for people living with HIV as they get older. In a news article by the university about the project, the study’s leaders explain they will be integrating the expertise of specialists in geriatric medicine with that of infectious disease experts to address the fact that HIV-positive people are experiencing age-related problems at a younger age than HIV-negative people."

Changes in Cerebral Function Parameters in HIV Type 1-Infected Subjects Switching to Darunavir/Ritonavir Either as Monotherapy or with Nucleoside ...

AIDS Research and Human Retroviruses:

Clinical Evaluation of the Potential Utility of Computational Modeling as an HIV Treatment Selection Tool by Physicians with Considerable HIV Experien

AIDS Patient Care and STDs - 25(1):29: "The HIV Resistance Response Database Initiative (RDI), which comprises a small research team in the United Kingdom and collaborating clinical centers in more than 15 countries, has used antiretroviral treatment and response data from thousands of patients around the world to develop computational models that are highly predictive of virologic response. ... Most physicians found the system easy to use and understand. All but one indicated they would use the system if it were available, particularly for highly treatment-experienced cases with challenging resistance profiles. Despite limitations, the first clinical evaluation of this approach by physicians with substantial HIV-experience suggests that it has the potential to deliver clinical and economic benefits."

Association of Age and Comorbidity with Physical Function in HIV-Infected and Uninfected Patients: Results from the Veterans Aging Cohort Study

AIDS Patient Care and STDs - 25(1):13: "A 50-year-old HIV-infected subject with chronic pulmonary disease had the equivalent level of function as a 68.1-year-old uninfected subject with chronic pulmonary disease. We conclude that age-associated comorbidity affects physical function in HIV-infected patients, and may modify the effect of aging. Longitudinal research with markers of disease severity is needed to investigate loss of physical function with aging, and to develop age-specific HIV care guidelines"

Flu vaccine recommendations for patients with HIV are 'justified'; vaccination encouraged

Aidsmap: "Recommendations that patients with HIV should be vaccinated against influenza “are justified,” according to an editorial in the January 1st edition of Clinical Infectious Diseases, and the use of the vaccine “should be encouraged.”"

California: Study Into HIV "Cure" Seeks Volunteers

The Body: "San Francisco researchers led by Dr. Jacob Lalezari are looking for HIV-positive volunteers to participate in a groundbreaking study that uses gene therapy to modify patients' immune systems.

"The study is based on work conducted in Germany on an HIV-positive man treated for leukemia. In 2007, the man received a bone marrow transplant from a donor with a rare genetic mutation that eliminates the CCR5 protein from the immune system. Without CCR5, HIV is unable to enter and infect T-cells. Three years after the transplant, HIV is undetectable in the patient.

"Lalezari, medical director at Quest Clinical Research and assistant clinical professor of medicine at the University of California-San Francisco, and his team are exploring a less invasive approach. Rather than undergo a costly and painful bone marrow transplant, volunteers will have their blood filtered to extract immune cells. Those cells will then be treated with a zinc finger nuclease that will remove the gene that produces the CCR5 protein. Following cultivation for about three months, a large dose of treated immune cells will be re-infused in the originating patient in the hope they "take root" and replace vulnerable cells.

"The treatment is expected to be painless and carry a relatively low risk of side effects."

Impact of flu vaccine opt-out is being seen as A(H1N1) returns to Europe

The Medical News: "As the UK and a number of European countries are now experiencing epidemics of influenza, including A(H1N1) which was the 2009 pandemic virus, the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) warns that the consequences of non-vaccination could emerge as a new flu emergency and are calling for greater efforts to encourage vaccination, not only for at risk groups but also health care workers."

Comment: It's not too late to get your annual flu vaccination.

Return of the "Death Panel" Myth is a "Travesty," Says Dr. Atul Gawande

Democracy Now: "DR. ATUL GAWANDE: Well, this change, which is to remove provisions that would have allowed for doctors to have additional payments to have end-of-life discussions with their patients, is an example of the mistake that repeal represents as a whole. End-of-life discussions are not death panels. But you say it over and over again, you brand it over and over again, and you begin to define what the meaning is of a major policy that’s passed. Being able to provide funding for discussions that have been shown to have a huge difference in improving the quality of life patients have and, in a recent study published in the New England Journal, also generated longer life for patients by helping them make better decisions about when to stop therapies that have become harmful to them, like that fourth round of chemotherapy and so on, those kinds of studies indicate we need more, longer and better discussions with doctors, overall. Repeal is a major mistake. Our choices are stalemate on making any kind of progress on healthcare at a time that the costs are going to be disastrous for our country over the next decade and at a time when more and more Americans are simply without health insurance.

"AMY GOODMAN: Well, let’s talk about what these end-of-life discussions are about. You wrote a very moving piece and also, I think, surprising piece called "Letting Go: What Should Medicine Do When It Can’t Save Your Life?" It appeared in The New Yorker magazine in August. You looked at a number of cases of people at the end of life, and you also looked at studies, like the Aetna study. You looked at La Crosse, Wisconsin. You looked at what happens when people start talking about the end of life."

Support for Winnipeg HIV lab faltered early, documents show

The Vancouver Sun: "Canada's chief public health officer decided to scrap plans to build a pilot HIV vaccine production facility more than six months before he told any of the four organizations vying for the project."

An Antiretroviral/Zinc Combination Gel Provides 24 Hours of Complete Protection against Vaginal SHIV Infection in Macaques

PLoS ONE: "Combination microbicide gels containing 14 mM zinc acetate dihydrate and 50 µM MIV-150 afforded full protection (21 of 21 animals) for up to 24 h after 2 weeks of daily application. Partial protection was achieved with the MIV-150 gel (56% of control at 8 h after last application, 11% at 24 h), while the zinc acetate gel afforded more pronounced protection (67% at 8–24 h). Marked protection persisted when the zinc acetate or MIV-150/zinc acetate gels were applied every other day for 4 weeks prior to challenge 24 h after the last gel was administered (11 of 14 protected). More MIV-150 was associated with cervical tissue 8 h after daily dosing of MIV-150/zinc acetate versus MIV-150, while comparable MIV-150 levels were associated with vaginal tissues and at 24 h."

The Price of Repealing the Affordable Care Act

HealthCare.gov: "As a result of the Affordable Care Act, families will soon be free from the constant worry that they will not be able to get health care when they need it the most. But repealing the law would strip Americans of this new freedom and take us back to the days when big insurance companies had the power to decide what care residents of the United States could receive—allowing them to once again deny coverage to children with pre-existing conditions, cancel coverage when people get sick, and place limits on the amount of care people can get, even if they need it. What’s more, without the law, insurance companies could overcharge for insurance just to boost their profits, or use fine print to deny medical treatments that are covered under people’s policies.

"In addition, repealing the law would add at least a trillion dollars to the deficit ...

* Over 1.2 million young adults would lose their insurance coverage through their parents’ health plans, sometimes just after they finish school and as they are looking for a job. Families across the United States would lose the peace of mind the Affordable Care Act provides by making sure that young adults can stay on their parents plan to age 26 if they do not have coverage of their own.

* Over 165 million residents of the United States with private insurance coverage would suddenly find themselves vulnerable again to having lifetime limits placed on how much insurance companies will spend on their health care.

* Insurance companies would once again be allowed cut off someone’s coverage unexpectedly when they are in an accident or become sick because of a simple mistake on an application. This would leave 15.9 million people in the United States at risk of losing their insurance at the moment they need it most, as one of the worst abuses of the insurance industry would become legal again.

* Over 165 million residents of the United States would not know if they are receiving value for their health insurance premium dollars, as insurers in state would no longer be required to spend at least 80 to 85 percent of premium dollars on health care rather than CEO salaries, bonuses, and corporate profits.

* New insurance plans would no longer be required to cover recommended preventive services, like mammograms and flu shots, without cost sharing, nor would they have to guarantee enrollees the right to choose any available primary care provider in the network or see an OB-GYN without a referral.

* 44.1 million seniors in the United States who have Medicare coverage would be forced to pay a co-pay to receive important preventive services, like mammograms and colonoscopies.

* Medicare would no longer pay for an annual check-up visit, so 44.1 million seniors in the United States who have Medicare coverage would have to pay extra if they want to stay healthy by getting check-ups regularly." [partial list]

CHAMP to Close, Networks to Continue

Community HIV/AIDS Mobilization Project: "The CHAMP Board and the broader HIV/AIDS community have recognized the critical importance of the HIV Prevention Justice Alliance (HIV PJA) and Project UNSHACKLE in pushing the HIV prevention justice vision forward, and we have already identified two organizations that are eager to provide them with the institutional support necessary to further their work.

The HIV PJA will be housed by one of its co-founding organizations, AIDS Foundation of Chicago (AFC). Founded by community activists and physicians in 1985... Julie Davids will continue to coordinate the HIV PJA as a decentralized network under the auspices of AFC.

"Project UNSHACKLE will continue as a project of the New York City AIDS Housing Network/Voices of Community Activists and Leaders (NYCAHN/VOCAL), a powerful model of grassroots community organizing and PWA leadership development. NYCAHN/VOCAL was CHAMP’s fiscal sponsor for our first several years, and throughout CHAMP’s existence, many NYCAHN/VOCAL members and staff have been involved as staff, members and Board members. Project UNSHACKLE fits well into their current work on healthcare in jails and prisons, and in the experiences of many of their members with imprisonment, probation, parole and re-entry.

"The Board would also like to recognize the enduring contribution of two individual CHAMP leaders in particular—Julie Davids, CHAMP’S visionary founder and current Director, and Waheedah Shabazz-El, CHAMP’s long-term, volunteer Community Organizer/Trainer and powerful organizer on behalf of women and all people living with HIV."

HIV/AIDS: Fund Rejection Worries Health Campaigners

IPS Inter Press Service – Telling Africa’s Untold Stories: "The proposal focused heavily on tackling transmission of HIV from mother to child by providing lifelong HIV/AIDS treatment to all HIV-positive pregnant women. Malawi had hoped to scale up its ARVs roll-out from 287,000 to 537,000 by the end of the funding year.

"Malawi had also planned to scale up voluntary male circumcision to help slow down the HIV infection rate that has stagnated at 12 percent since 2007. Nearly one million men could have been circumcised within the implementation period.

"Mkawa said no reasons were given for the rejection of the proposal. 'We are yet to receive the reasons as to why the proposal has been turned down by the world body,' she told local journalists. However, to some the rejection hasn't come as a surprise.

"Médecins Sans Frontières (MSF), an international humanitarian aid organisation better known as Doctors Without Borders, had warned in an article on its website on December 8 that due to budget shortfalls, several African countries 'may be disqualified from HIV/AIDS funding in the near future'."

ViiV Healthcare Opens Its Patient Assistance Program For People With HIV

The AIDS Beacon: "The program will cover the medications Combivir (zidovudine/lamivudine), Epivir (lamivudine), Epzicom (abacavir/lamivudine), Lexiva (fosamprenavir), Rescriptor (delavirdine), Retrovir (zidovudine), Selzentry (maraviroc), Trizivir (zidovudine/lamivudine/abacavir), Viracept (nelfinavir), and Ziagen (abacavir). Eligible participants must have an annual household income of no more than 500 percent of the federal poverty level ($72,850 for a family of two) and no prescription drug coverage for brand-name drugs. Patients on Medicaid are eligible if they meet income requirements and have spent $600 or more out of pocket for their HIV medications. For more information or to apply for the program, please see the ViiV Healthcare website."

Vitamin D deficiency increases risk of type 2 diabetes for patients with HIV

Aidsmap: "Vitamin D deficiency is associated with an increase risk of type 2 diabetes for patients with HIV, Italian investigators report in the online edition of AIDS.

"The study also showed that almost two-thirds of HIV-positive patients had inadequate levels of vitamin D.

"'Studies should examine whether vitamin D supplementation can prevent or treat type 2 diabetes mellitus in HIV and possibly reduce complications associated with HIV infection and its treatment,' recommend the researchers."

FDA Approves Gardasil as First Anal Cancer Vaccine

POZ: "Though anal cancer is relatively rare in the general population, rates are far higher in men who have sex with men (MSM), and it’s nearly 60 times more common in HIV-positive MSM. For this reason, providers who treat people with HIV have been eager to see the vaccine approved for this purpose."

Researchers: CROI late-breaker deadline Jan. 13

The late breaker abstract submission deadline for CROI 2011 is Thursday, January 13 at 5:30 pm ET. The Call for Abstracts (including guidelines for submission, abstract format, and subject categories) is available at www.retroconference.org, as well as the Program at-a-Glance.

Cohort Highlights Factors Linked to Lower Risk of Cancer Death in HIV

POZ: "CD4 counts, before starting ARV treatment, were low among those who developed invasive cancer—the average was 45 cells. Most (92 percent) patients were on ARV therapy at the time of their cancer diagnosis, with CD4s averaging 204 cells and viral loads averaging 400 copies. ...

"The risk of death was lowest among those who had higher CD4 counts at cancer diagnosis and viral loads less than or equal to 400. The risk was also lowest among those who actually received treatment for their cancer(s), and those who had infection-related cancers--such as human papillomavirus-associated anal cancer and Epstein-Barr virus-related lymphoma—compared with cancers not associated with an infection (such as lung cancer). ...

"One of the more sobering, yet manageable, findings of the study was that more than 50 percent of the people living with HIV diagnosed with cancer in the cohort had stage IV disease at the time of diagnosis. In addition, at least 25 percent of patients received no treatment.

"'This is surprising,' Achenbach and his colleagues write, 'as individuals in this study were receiving [ARV treatment] in specialized HIV clinics and routinely engaged in care with quarterly monitoring on average. Although it is possible that HIV infection and associated immune system dysfunction accelerate the rate of cancer progression to advanced and untreatable states, our findings could be explained by poor cancer awareness, inadequate screening practices, or lack of prompt therapy.'"

India rejects Abbot lab's patent application for HIV drug

The Economic Times [India]: "MUMBAI: India has rejected a drug patent application of a US multi-national pharma company, paving way for easy access to an important life-saving medication for HIV patients across the globe.

"The decision to reject the patent application on the important combination drug, Lopinavir/Ritonavir filed by Abbot Laboratories was given by the Indian patent office here during the weekend and it is a major victory to millions of HIV-positive patients around the globe, according to NGOs working with affected patients."

Portugal's drug policy pays off; US eyes lessons

Washington Post: "Drugs in Portugal are still illegal. But here's what Portugal did: It changed the law so that users are sent to counseling and sometimes treatment instead of criminal courts and prison. The switch from drugs as a criminal issue to a public health one was aimed at preventing users from going underground.

"Other European countries treat drugs as a public health problem, too, but Portugal stands out as the only one that has written that approach into law. The result: More people tried drugs, but fewer ended up addicted."

Earlier HIV Treatment Should Be Priority in Developing World

POZ: "Earlier initiation of antiretroviral (ARV) therapy should be the highest priority as global health experts begin implementing the 2010 World Health Organization (WHO) recommendations for HIV treatment in resource-limited counties, according to a paper published last week in PLoS Medicine.

"'Immediate scale-up of the entire WHO guideline package may be prohibitively expensive in some settings,' said lead author Rochelle P. Walensky, MD, of the Massachusetts General Hospital in Boston. 'In many resource-limited settings, the relevant policy question is: What to do first?'

"Since 1981, AIDS has killed more than 25 million people, and about 33 million people—the vast majority of whom are living in low- and middle-income countries—are now living with HIV."