Staff Writer Jax Gay
An insurer has paid a settlement of more than $17 million after it accidentally outed people with HIV.
Aetna, a US-based health care insurance company, had faced legal action over letters sent in large transparent envelopes to around 12,000 customers living with HIV last year.
The letters, which contained new instructions for filling prescriptions, were sent to all customers taking medication for HIV treatment, as well as those taking HIV-preventing pre-exposure prophylaxis (PrEP) drugs.
In a shocking lapse, information about the HIV status of the patients was printed to be clearly visible through the plastic window of the envelopes, below the address.
HIV campaigners say the lapse has left many people “devastated” as their HIV status was unlawfully disclosed to anyone who happened to see the envelope.
The case was settled this week – with the insurer making a massive payout to victims.
Under the terms of the proposed settlement, which is now subject to the Court’s approval, Aetna has agreed to pay $17,161,200 to resolve the claims.
Under the settlement, 11,875 people who had their HIV status shared are entitled to receive at least $500 each.
An additional 1,600 patients are entitled to $75 as their names and other information was disclosed.
In a release Ronda B. Goldfein, executive director of the Philadelphia-based AIDS Law Project of Pennsylvania, said that because stigma associated with HIV is still pervasive, some people who received the mailing were forced from their homes or suffered irreparable damages to relationships with friends, relatives, and neighbors.
He said: “The fear of losing control of HIV-related information and the resulting risk of discrimination are barriers to health care.
“This settlement reinforces the importance of keeping such information private, and we hope it reassures people living with HIV, or those on PrEP, that they do not have to choose between privacy and health care.”
Among those sent the mailing was ‘Andrew Beckett’, a Pennsylvania resident who became the lead plaintiff in the nationwide class action lawsuit.
Beckett is not HIV-positive but takes PrEP, a pre-exposure prophylactic that prevents HIV.
He said: “HIV still has a negative stigma associated with it, and I am pleased that this encouraging agreement with Aetna shows that HIV-related information warrants special care.”
Sally Friedman, legal director of the New York City-based Legal Action Center, said: “The settlement provides a fair and just way to compensate class members for their harm while also requiring practice changes to prevent future breaches.
“The settlement’s magnitude will help restore the dignity and voice of those affected.”
Shanon J. Carson, a managing shareholder of Berger & Montague, P.C., added: “Not a day has gone by that I and my colleagues have not paused to think about the individuals and their families who have been affected by this breach, and we are glad that this settlement will bring closure and a remedy to this situation.”
Torin A. Dorros, managing attorney of Dorros Law, which filed a subsequent lawsuit in California over the issue, called the outcome “a very significant resolution for all those affected and a landmark settlement in the area of protecting consumers’ health information and privacy.”
Patients in Arizona, California, Georgia, Illinois, New Jersey, New York, Ohio, Pennsylvania, and Washington, D.C were impacted.
In the UK, a sexual health clinic was hit with a massive fine in 2016 after accidentally leaking a list of HIV-positive patients on an email chain.
56 Dean Street made the slip when it sent an email newsletter to patients at its HIV clinic – but failed to prevent recipients from seeing eachothers’ details – revealing the names and email addresses of 780 people.
Health Secretary Jeremy Hunt slammed the breach as “completely unacceptable”, and Chelsea and Westminster Hospital NHS Foundation Trust, which runs the clinic, was fined £180,000 over the data breach.
Information Commissioner Christopher Graham said: “People’s use of a specialist service at a sexual health clinic is clearly sensitive personal data. The law demands this type of information is handled with particular care following clear rules, and put simply, this did not happen.
“It is clear that this breach caused a great deal of upset to the people affected.
“The clinic served a small area of London, and we know that people recognised other names on the list, and feared their own name would be recognised too.
“That our investigation found this wasn’t the first mistake of this type by the Trust only adds to what was a serious breach of the law.”
Staff Writer Jax Gay
The flu virus has reached nearly every corner of the nation.
Influenza activity is widespread in all states except Hawaii (and the District of Columbia), according to the weekly flu report released Friday by the US Centers for Disease Control and Prevention.
"Flu is everywhere in the US right now," said Dr. Dan Jernigan, director of the CDC's influenza branch. "This is the first year we've had the entire continental US at the same level (of flu activity) at the same time." It has been an early flu season that seems to be peaking now, he said, with a 5.8% increase in laboratory-confirmed cases this week over last.
There were 11,718 new laboratory-confirmed cases during the week ending January 6, bringing the season total to 60,161. These numbers do not include all people who have had the flu, as many do not see a doctor when sick.
Seven additional pediatric deaths were reported during the week ending January 6, bringing the total for the season to 20.
For older people, the CDC estimates deaths based on pneumonia and influenza. Based on National Center for Health Statistics data, 7% of all deaths that occurred during the week ending December 23 were due to pneumonia and influenza. This is above the rate considered normal for this period, according to Lynnette Brammer, head of the CDC's Domestic Flu Surveillance team.
Additionally, 22.7 hospitalizations for every 100,000 people occurred over the week ending January 6, compared with 13.7 per 100,000 for the week ending December 30. Those older than 65 represent the largest group hospitalized, though people within the 50-to-64 age range and children younger than 5 are also experiencing high rates of hospitalization.
"We are currently in the midst of a very active flu season, with much of the country experiencing widespread and intense flu activity," CDC Director Dr. Brenda Fitzgerald said. "The flu season may be peaking now. We know from past experience it will take many more weeks for flu activity to slow down."
Brammer said, "Basically, it looks like things are starting to level off. We didn't see the sharp increases that we saw the last couple of weeks."
"Over the next few weeks, we'll know if we peaked or not," she said. "I would hope that the areas that have been hit a little bit earlier in the South and up the West Coast, I'm hoping that those people -- particularly some of the states in the South -- may have hit their peak and are on their way down."
Some of the northern states may still be going up in the number of flu cases, she said. "I wouldn't be surprised to see that. But, either way, one of the really important things to remember is there are, probably for everybody, weeks to go in this flu season."
Vaccine effectiveness has not been calculated, but officials know that the most common strain making people sick this year is H3N2, Brammer said.
Jernigan said H3N2 seasons are associated with higher rates of hospitalizations and deaths, as well as with lower vaccine effectiveness. He believes that when calculations are made at season's end, vaccine effectiveness may be around 30% for this season.
Dr. William Schaffner, an infectious disease specialist at Vanderbilt University, provided a nutshell description of this season: "Started early; it then blossomed essentially all over the country more or less simultaneously. The upswing has been dramatic, and essentially the entire country is affected -- some parts more than others -- but flu is everywhere."
Schaffner suspects that holiday travel helped transport the flu virus and expedited its transmission. "All those hugs and kisses ... we're seeing the consequences now."
H3N2, this year's predominant strain, "tends to produce more severe disease, particularly among older persons," Schaffner said. "Doctors' offices, clinics and emergency rooms all over the country are feeling the H3N2 impact right now."
Generally, people most at risk for complications are older people, children and people with weak immune systems.
"Influenza and its complications disproportionately affect people who are 65 and older," Schaffner said. "They account for 80% of the deaths, and then there are also deaths in younger people, often who have underlying illnesses, such as heart disease, lung disease, diabetes, and also in some young children."
Two tragic deaths
However, flu can also claim the lives of healthy adults such as Jenny Ching, 51, who died January 5 after battling what she thought was just a bad cold.
Her husband, Matt Ching, told WCVB that the Massachusetts resident "had the flu, and she also developed a bacterial infection, and it was just really severe and caused severe pneumonia, and her body just didn't react to antibiotics."
Ching said he wasn't sure whether his wife had gotten a flu shot this season, though in seasons past, that was the norm for the mother of two boys, ages 9 and 7.
Schaffner noted that "the usual flu death is a person who gets influenza, gets all that inflammation in their chest and then has the complication of pneumonia." The flu "can take a perfectly healthy person -- a child, a young adult, robust -- and put them in the ER in 24 to 48 hours."
That was the case for Kyler Baughman, 21, who died unexpectedly December 28 at UPMC Presbyterian Hospital in Pittsburgh. "Robust" characterizes Baughman perfectly.
The Latrobe, Pennsylvania, resident, who often posted pictures of himself at the gym on Facebook, was studying to be a physical trainer and worked not one but two jobs, his mother told WPXI.
"It doesn't seem real," said his mother, Beverly. She recounted that her son looked run-down when she saw him December 23. On December 26, Baughman went to work but left early because he wasn't feeling well. The next day, he visited the ER at Westmoreland County Hospital. Health personnel immediately decided to fly him to UPMC, where he died less than 24 hours later.
The cause of his death, as reported by the Allegheny County Medical Examiner, was influenza, septic shock and multiple organ failure. Unlike the usual flu death resulting from pneumonia complications, Schaffner said, "this is a different phenomenon."
The viral flu infection stimulated an immune and inflammatory response in Baughman's body. "This happens to everyone," Schaffner noted, but when the person is a "very strong, robust person," there are times when that response is "overwhelming." In such cases, cytokines -- proteins created as part of the inflammatory response -- create a "cytokine storm" in the body. "And this cytokine storm can actually lead to sepsis in the person."
Braugham's parents hope that by sharing his story, they might save someone else.
"I just think he ignored it and thought it would go away, like most people," his mother said. Added his father, Todd: "Don't let things go. Whenever you have fever and you have it multiple days, don't let it go. Get it taken care of."
Different states, different responses
Alabama Gov. Kay Ivey declared a state public health emergency because of the flu on Thursday.
Scott Harris, acting state health officer at the Alabama Department of Public Health, said the influenza outbreak includes high activity throughout the state but particularly in metropolitan areas. This "crush" means some hospitals are operating over capacity, leaving some patients sitting in ERs. The public health emergency order helps health care professionals manage resources more efficiently and provides leeway so alternative care can be provided when personnel are unable to offer standard care.
"If you're sick, please try to stay home if you can do that and get in touch with your health care provider," Harris said.
On the West Coast, Dr. Jasjit Singh, a pediatric infectious disease specialist at Children's Hospital of Orange County, said 27 influenza-related deaths have occurred in California as of December 30: all among adults under 65 years old.
"It's been an earlier flu season than in years past," Singh said. As of January 6, the hospital has admitted about a quarter of the 303 patients seen with influenza A infections, compared with about 19% of the 89 cases seen last year at this time. Meanwhile, of 78 influenza B cases, about 13% required admission, compared with 22% of 27 cases last year.
Overall, California reported 7,306 laboratory-confirmed cases for the season as of December 30.
Texas, which laboratory-confirmed 5,585 cases of the flu as of that date, is seeing activity levels "at the highest level -- widespread -- for a few weeks," said Lara M. Anton, a press officer for the Department of State Health Services.
Because the Lone Star State counts flu deaths from death certificate codes, there's also a "significant lag" between when a death occurs and when the death is reported, she said. However, the majority of deaths this season occurred among people 65 and older.
"There are reports of hospitals throughout the state that have needed to divert non-emergency ambulances for periods of time because of overcrowding in their ER," Anton said. With most hospitals coming off "divert status" within the same day, the state's hospital system has been managing the increased number of patients. The department continues to monitor the situation closely and "will step in with support when it is requested," she said.
Texas is encouraging "anyone with symptoms to stay home and to see their health care provider, as antiviral medications may shorten the duration of their illness," Anton said. Amid an outbreak in San Antonio, one school took that advice to heart and closed Friday for a "flu day."
Staff Writer Jax Gay
Hepatitis A Outbreak Is Putting Men Who Have Gay Sex At Risk
The outbreak of hepatitis A is a strain similar to those in Europe and the USA.
To combat a worrying outbreak of hepatitis A in the southern Australian of Victoria, the state government there has launched a free vaccination program for men who have sex with men (MSM).
Victoria has had 27 confirmed cases of hepatitis A in the past nine months.
All of those cases were men. Many of them had had sex with other men and had not travelled abroad. A few of those new cases were people had injected drugs in the past year.
The free vaccination program will run for most of this year starting from 22 January until 31 December.
How does it work?
Those eligible for the program are MSM in Victoria and all people who have injected drugs in the past 12 months.
They will get a free, two-dose course of hepatitis A vaccine
‘Immunization saves lives and protects others in the community,’ said Victoria’s deputy Chief Health Officer, Dr. Brett Sutton.
‘It is important that all eligible people get the free hepatitis A vaccine to stop the spread of this serious disease.’
How to prevent Hep A (other than vaccination)
The disease is spread through person-to-person transmission, including sexual activity. It can also occur sharing needles, and through consuming of contaminated food and water.
‘It’s important to wash your hands and your body after sex to help stop the spread of hepatitis A. Make sure you’re using condoms and changing condoms between any sexual activity,’ Dr. Sutton said.
‘We also strongly advise any confirmed cases with hepatitis A against engaging in any sexual activity that could increase the spread of the virus.’
Symptoms can start to show up between 15 to 50 days coming into contact with hepatitis A. Symptoms, include fever, nausea, vomiting and abdominal pain, followed by dark urine and yellow skin/eyes – also known as jaundice.
‘People can be infectious and transmit the infection to others for up to two weeks before they become unwell,’ Dr. Sutton said.
‘This means it is especially important to get vaccinated if you are at risk and are a food handler, healthcare worker or childcare worker, because you might transmit infection to vulnerable people before you realize you are ill.’
The Victorian Government has also made free vaccinations available for MSM to prevent meningococcal disease, human papillomavirus (HPV) and hepatitis B. The first two are available until 31 December. But the hepatitis B vaccine is available as a long-term approach to protect against liver disease and liver cancer.
‘Vaccination is safe, effective and provides the best protection against serious diseases. I urge all MSM to get all four free vaccines without delay,’ Dr. Sutton said.
Hep A in Europe and the USA
The hepatitis A strains detected in the Victorian outbreak are similar to those circulating in Europe.
Since 2016, hepatitis A outbreaks among MSM were reported in 16 European countries and across the United States.
A similar outbreak was reported in the Australian state of New South Wales in 2017.
MSM in Victoria who want to get the free vaccine should go to their GP or nearest sexual health clinic.
Staff Writer Jax Gay
For more than 30 frustrating years, doctors have struggled to find a cure for HIV. Now, with the help of stem cell research, they’re closer than ever before.
“This approach has the potential to provide lifelong immunity to HIV,” Dr. Scott Kitchen, an associate professor of hematology and oncology at UCLA’s David Geffen School of Medicine, told JaxGay.com. A UCLA AIDS Institute faculty member, Kitchen’s research centers on immune system abnormalities, focusing on the Human Immunodeficiency Virus, or HIV. In more than a dozen published studies, Kitchen has researched why immune cells do not destroy AIDS, and clarified why early AIDS/HIV drugs failed. He recently received a $1.7 million grant from California’s Stem Cell Agency to continue his research to HIV.
“The cells effective in combating the virus were entirely stem-cell generated. What is significant is the cells were able to respond,” he said of his recent work. Because stem cells are capable of regenerating and growing new cells repeatedly, Kitchen’s findings show how stem cell-treated immune cells could destroy HIV and continue to destroy any recurring HIV infection—something that has not been seen before.
AIDS/HIV became the world’s leading infectious killer because the human immune system’s T-cells—which can usually slash all kinds of viruses and bacteria—were never strong enough to vanquish HIV. Kitchen is testing stem-cell-generated T-cells that can overpower the HIV virus like never before.
When the battle against AIDS/HIV began three decades ago, stem cell research was in its infancy. Scientists knew little about how to harness its potential, or even whether it might be useful in treating HIV. The first cases of AIDS, or Acquired Immunodeficiency Syndrome, were reported in 1981. A 1982 New England Journal of Medicine article highlighted doctors’ concerns about a mysterious, unknown immune deficiency that had taken the lives of several young gay men. Since then, the World Health Organization estimates about 35 million people have died of HIV infection.
AIDS/HIV is not the death sentence it once was, thanks to daily medications. Antiretroviral drugs, called ARTs or ARVs, are taken by many HIV patients. ARVs slow but cannot halt the progression of infection. According to the U.S. Department of Health and Human Services, ARVs are the reason the annual number of HIV-related deaths has decreased in the U.S. since the 1990s.
Yet, according to National Institutes of Health data, about 95 percent of those living with HIV are in developing countries, where it is still fatal, and where it has orphaned millions of children.
At the start of the epidemic in the 1980s, researchers worldwide began exploring treatments using animal subjects. Back in 2011, Kitchen co-authored “Stem cell-based approaches to treating HIV infection” in the journal Current Opinion in HIV and AIDS. He wrote that stem cell-based strategies for treating HIV were “a novel approach toward reconstituting the ravaged immune system with the ultimate aim of clearing the virus from the body.” Stem cell treatments utilize patients’ own cells for testing on humans, not animals, specifically targeting HIV, which by then had become one of “the dominant strategies under development,” in his view. Kitchen still utilizes some animal-based research, but stem cell advances will make large clinical trials possible, and “have provided the impetus for a renewed and expanded interest in the development of new cell-based strategies to treat HIV infection as well as a variety of other diseases.”
What’s next? Large clinical trials on human patients to demonstrate safety of treatments.
Over many years of experimenting, Kitchen has demonstrated how stem-cell-generated treatments can be recast from laboratory animal experiments into safe tests for human volunteers—which has been problematic throughout the history of HIV research. “A hallmark of our studies is safety,” Kitchen said. “It really shows that modifying of (the human immune system’s) T-cells could be done in a clinical setting.”
Safety has been the paramount factor. The experimental process includes bone and blood procedures, and past experiments have proven to be too strenuous and unsafe for patient volunteers. Some HIV patients suffer from drug side effects, or weakness even when medication allows them to live a somewhat normal life. So volunteering for experimental procedures is arduous — a reality that has left previous results less useful as a predictor too.
Current research worldwide has immense potential, but one thing’s for sure after 30 years: Kitchen’s method has great potential.
Stem cell advances to potentially eradicate HIV are crucial. According the Kaiser Foundation’s analyses of U.S. Funding for HIV/AIDS data, $32 billion was spent during fiscal year 2017, and individual states spend millions. California alone spends about $1.8 billion annually, and ranks second in the nation in cases of HIV, with more than 170,000 cases.
Funding has historically been a challenge— one that a cure would quash. Antiretroviral drugs, or ARVs, are taken daily by many HIV patients. ARV costs are state-supported in some states but not others, which means that pharmaceutical companies offer patient-affordability programs for some ARVs but not others. Because HIV wears down the immune system, some patients are in better health than others based on their geographical location and socioeconomic status and therefore need unequal kinds of drugs. Diverse insurance plans cover some but not all ARVs: Some patient co-pays exceed $600 or even $2,000 per month.
As the U.S. Department of Health and Human Services puts it, “Understanding HIV and ART (antiretroviral therapy) related-costs in the United States is complicated because of the wide variability in medical coverage, accessibility, and expenses across regions, insurance plans, and pharmacies . . . and financial barriers to (patients) filling their prescriptions.”
Stem cell innovation may drive down these complex, high HIV costs. There are currently an estimated 36.7 million people living with HIV worldwide; of those, about 18.2 million take ARVs throughout their lives. Local agencies work to insure patients get the drugs they need so that HIV will not spread, as that costs even more in public health crises.
ARVs suppress the virus, but do not destroy it. According to the Centers for Disease Control and Prevention, there are about 1.1 million people in the U.S. living with HIV, and about 166,000 who do not know they are infected. Making sure that HIV-positive individuals get tested is critical to the public health goal of preventing its spread. About 30 percent of new infections are transmitted by people who do not know they have HIV infection, and that is how it continues to be spread. “It’s bad enough people are dying of AIDS, but no one should die of ignorance,” the late AIDS activist and actress Elizabeth Taylor once said.
“There are a lot of researchers working on developing stem cell therapies for HIV,” CIRM’s McCormack notes. CIRM has invested around $73 million in several HIV projects. “We fund different approaches because at this stage we don’t know which approach will be most effective, and it may turn out that it’s ultimately a combination of these approaches, or others, that works,” McCormack explained.
Living HIV-positive while navigating costs, being HIV-infected and not knowing it, fighting to stop infection in places where it’s fatal, perennial funding of research and treatment—closure for all of this would be welcome.
Staff Writer Jax Gay
Scientists began testing a new HIV drug in pigs to promising results.
Patients only need to take the pill once a week if it goes forward and doctors release it. Most patients currently take HIV medication daily.
When taken, the capsule dissolves and star-shaped structure unfolds inside the stomach. This structure eventually releases its medicine over the course of seven days. Eventually, it too dissolves and passes through the digestive system.
Most experts and doctors find promise in the drug, but caution there needs to be more testing — such as on monkeys. The researchers optimistically believe trials with people could begin in two years.
The research was published in Nature Communications. Bill and Melinda Gates Foundation, the National Institutes of Health, and the Brigham and Women’s Hospital funded the project.
A lot of the rallying behind medication like this stems from convenience for patients.
‘Changing a medication so it only needs to be taken once a week rather than once a day should be more convenient and improve compliance,’ said Giovanni Traverso, a researcher from Massachusetts Institute of Technology and Brigham and Women’s Hospital in the US.
‘Medical advances have come on leaps and bounds’
A company, Lyndra, is developing the technology. They want to plan human trials within the next 12 months.
‘Medical advances have come on leaps and bounds for HIV in the UK in recent years,’ said a representative at Terrence Higgins Trust. ‘However, we do know that taking a pill each day does present practical barriers for some people living with HIV. We welcome the prospect of a treatment that removes these barriers, and presents all people living with HIV with further choice, provided that it is no less effective than current options available.’