Scripps researchers awarded two grants to support studies on cocaine, oxycodone addiction

April 27, 2018

Last year, more than 60,000 Americans died of an opioid overdose, and millions more struggled with opioid and cocaine addiction. To get to the roots of why some people are more prone to drug addiction than others, researchers at The Scripps Research Institute are launching a pair of studies on genetic factors behind oxycodone and cocaine addiction and treatment.

In support of the research, the National Institute of Health’s National Institute on Drug Abuse (NIDA) has awarded the Scripps Research team two separate grants totaling $7.5 million. The five-year grants will allow the researchers, led by Olivier George, PhD, associate professor in the Department of Neuroscience at Scripps Research, to combine next-generation sequencing with state-of-the-art behavioral screening in a unique, genetically diverse, nonhuman animal model of drug addiction, and screen genetically diverse rats for their propensity for drug addiction and create shared tissue banks for researchers around the world to use in addiction studies.

For the studies, George’s group is collaborating with the lab of Leah Catherine Solberg Woods, PhD, at Wake Forest University, who will breed the rats, and the lab of Abraham Palmer, PhD, at the University of California, San Diego, who will genotype the animals. The behavioral testing and biobanking will be completed at Scripps Research.

“The big questions right now are what the genetic mechanism is that makes someone vulnerable to drug addiction, and why one medication works for someone, but not someone else,” says George. “It’s hard to study that in humans because individuals are also exposed to such different environments, which bias the results.”

Rodent studies have also been limited, George says, because most labs use strains of rodents with little variation in their genetics between individual animals. This makes it hard to find animals with drastically different genetic and behavioral profiles. In addition, rodent studies usually rely on a few dozen animals at most, since screening each animal’s behavior is so labor intensive. But armed with the new grants, George’s team will study about around 2,500 genetically different rats.

“Scripps Research is one of the only places in the world where you can do this type of large-scale behavioral study because of the equipment, expertise, and resources we have,” George says. “There is an amazing team of people here.”

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The rats in the new studies are a good model for the genetic diversity of the human population because they were created by cross-breeding many different strains, George says. “They are not your typical albino laboratory rats. They vary in their color, size, appetite, anxiety levels, memory skills, and now we have evidence that they also vary in their addiction tendencies,” he adds.

In addition to screening the rats for compulsive drug use and addiction-related behaviors, George’s group will study whether genetic variation affects how individuals respond to current medications used to treat addiction. The collaboration with the Palmer lab, which will perform the genotyping, will then allow the team to identify gene variants that may predict the vulnerability to addiction or the efficacy of a given medication.

The animals will have access to either cocaine or oxycodone for 6 to 12 hours a day-;a much longer time period than most rat studies-;so that drug use leads to the same set of negative symptoms and compulsive-like behaviors seen in humans.

The team plans to collect samples from the animals-;including blood, urine, feces, a variety of organs and even blood cells capable of producing stem cells-;and save them in two tissue banks, dubbed the CocaineBiobank and OxycodoneBiobank. Researchers from other institutions will then be able to access the samples, and the corresponding genetic information and behavioral results, to launch their own studies on addiction. For instance, George imagines microbiome researchers using the feces samples to correlate bacteria in the rats’ guts with their addiction propensity.

“The reception from the community has been fantastic already. We have just started the research, and we already have a lot of requests for samples,” says George.

Source:

https://www.scripps.edu/news/press/2018/20180426-opioid-cocaine-addiction-.html

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Podcast: KHN’s ‘What The Health?’ What’s Next For The VA?

The Trump administration has withdrawn the nomination of White House physician Ronny Jackson to head the Department of Veterans Affairs after allegations surfaced about inappropriate handling of prescription drugs, issues with alcohol and difficulties working with other White House medical unit staffers. It is unclear whom the White House will turn to next to take over the helm at the VA.

Meanwhile, on Capitol Hill, Republicans and Democrats in the House and Senate are working on legislation to address the nation’s opioid epidemic, although there are doubts about how effective the proposals might be and whether what is really needed is more money.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Sarah Kliff of Vox.com, Alice Ollstein of Talking Points Memo and Anna Edney of Bloomberg News.

Among the takeaways from this week’s podcast:

  • The Department of Veterans Affairs is an enormous bureaucracy with hundreds of thousands of employees and the largest health system in the United States. Even before Jackson’s nomination collapsed under accusations related to his behavior, many senators from both parties questioned his lack of managerial experience. But the White House’s muddled handling of the situation may make even those well-qualified for the job reluctant to sign on.
  • On the regulatory front, the comment period for the so-called skinny plan rule closed this week. It’s clear the Trump administration wants to expand the availability of short-term plans, but health insurers and other health industry stakeholders worry that healthy people will flock to cheaper, less comprehensive plans, leaving sicker consumers with ever-more-expensive alternatives.
  • How states are viewing Medicaid expansion also continues to be a hot topic. In Ohio, a state with a Republican governor who embraced this aspect of the Affordable Care Act, the expansion continues to be a target among GOP gubernatorial candidates who want to succeed him. Meanwhile, sitting Gov. John Kasich is seeking a work requirement waiver that goes beyond many others that have been advanced so far. And a legal challenge to Kentucky’s Medicaid work requirement, which is expected to land in federal court in June, could shape how other red states decide to proceed.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too.

Julie Rovner: Politico, “Should Doctors Check Your Electric Bill?” by Brett Norman

Sarah Kliff: Politico, “Maine Governor Defies Ballot Initiative Expanding Medicaid,” by Rachana Pradhan

Alice Ollstein: Politico, “Trump Challenges Native Americans’ Historical Standing,” by Dan Diamond

Anna Edney: NPR, “How Medicare’s Conflicting Hospitalization Rules Cost Me Thousands Of Dollars,” by Alison Kodjak

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunes, Stitcher or Google Play.

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‘Rapid Autopsy’ Programs Seek Clues To Cancer Within Hours Of Death

After Keith Beck died of bile duct cancer last year, family members said more than 900 people showed up to pay respects to the popular athletic director at the University of Findlay in northwestern Ohio.

Many were former students who recalled acts of kindness during Beck’s nearly 30-year career: $20 given to a kid who was broke, textbooks bought for a student whose parents were going through bankruptcy, a spot cleared to sleep on Beck’s living room floor.

But few knew about Beck’s final gesture of generosity. The 59-year-old had agreed to a “rapid autopsy,” a procedure conducted within hours of his death on March 28, 2017, so that scientists could learn as much as possible from the cancer that killed him.

“He was 100 percent for it,” recalled his ex-wife, Nancy Beck, 63, who cared for Beck at the end of his life. “It wasn’t the easiest thing to do, but it was important.”

Beck donated his body to a rapid-autopsy research study at the Ohio State University, part of a small but growing effort by more than a dozen medical centers nationwide. The idea is to obtain tumor tissue immediately after death — before it has a chance to degrade. Scientists say such samples are the key to understanding the genetics of cancers that spread through the body, thwarting efforts to cure them.

“People are recognizing that cancer is more heterogeneous than we realize,” said Dr. Sameek Roychowdhury, a medical scientist at OSU’s Comprehensive Cancer Center. “Different parts of your body may have different cancer cells, even though they originated from the same cancer.”

In Beck’s case, results from the rapid autopsy showed he had developed a mutation that caused the experimental drug he was taking, known as an FGFR inhibitor, to stop working. Roychowdhury and colleagues plan to report on Beck’s case in an upcoming paper.

“This is helping us shape how we develop this new drug,” Roychowdhury said. “How can we make a better drug? Or can we make a better drug combination?”

Rapid-autopsy technology has been available for decades. Researchers at the University of Washington in Seattle have been using the technique to study prostate cancer since 1991. Scientists at the University of Nebraska Medical Center launched a now-robust program in 2000.

But only in recent years have more hospitals been launching and expanding programs, said Dr. Jody Hooper, director of the Legacy Gift Rapid Autopsy Program at Johns Hopkins Medicine in Baltimore. At last count, there were 14 similar programs in the U.S.

Funding for them varies, Hooper said, but typically they’re supported by a mix of cancer program resources, grants and researcher fees.

Scientists recognize the value of examining tissue from multiple sites soon after death and obtaining larger samples than they could while a patient was living. Cancer cells can be retrieved during such autopsies and kept alive, allowing researchers to experiment with ways to treat — or kill — them.

“It’s the power of sampling over the entire body at the same time,” said Hooper, who conducts about one rapid autopsy a month, often providing tissue for up to a half-dozen researchers interested in different questions.

Most programs focus on cancer, but efforts are underway to expand the practice, possibly to shed light on virus reservoirs in HIV patients, for instance.

Speed is essential to preserve RNA and DNA, the building blocks of cells, which can degrade quickly after death. It’s best to obtain specimens of living cells within six hours of death and other tissue within 12 hours, Hooper said.

The need for speed is also what makes such autopsies challenging. Families must consent to the procedure, often while freshly grieving their loved one’s death. And the logistics surrounding retrieving a body, conducting an autopsy and then returning the body for a funeral are often complicated. Traffic is unpredictable and “one time, there was a blizzard,” Hooper said.

Roychowdhury said he and one of his clinical fellows are on call at all times.

“The patients have our cellphone numbers, as well as the next of kin,” he said.

Broaching the subject with patients and families requires tact and compassion. Most patients are enrolled in clinical trials and learn about the autopsies from their doctors or pathologists like Hooper. Many are willing, even eager, to cooperate, she said.

“These are mostly patients with metastatic cancer,” she said. “They’ve made their peace with the outcome long before.”

For some, the rapid autopsy is simply the final phase of the clinical trial.

“They want to do something not only for themselves, but also to help others,” Roychowdhury said.

That’s how Linda Boyed, 52, of Lewis Center, Ohio, sees it. Like Beck, she has bile duct cancer and is enrolled in a trial to treat it. The drugs are working now, but Boyed said she has agreed to a rapid autopsy after death so scientists can learn from her when they’re no longer effective.

“I have a strong Christian faith,” she said. “I believe we’re put on this Earth to help each other.”

Because the rapid autopsies are paid through program funds and grants, there’s no cost to the families. Bodies are returned within a day and in a condition that doesn’t affect funeral plans.

“My emphasis is that it was all done with dignity and respect,” said Nancy Beck. “We felt honored to be able to do this.”

Performing the autopsy after treating a patient in life is an honor for doctors, too, Roychowdhury said.

“This was once a living, breathing person that came into my office every other week,” he said. “The thing I want to think about each day is that they’ve given so much so that others can benefit.

“Everyone has something to teach us after death.”

KHN’s coverage of end-of-life and serious illness issues is supported in part by the Gordon and Betty Moore Foundation.

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AbbVie’s beat fueled by demand for Humira, Hep C drugs

(Reuters) – AbbVie Inc reported a better-than-expected quarterly profit on Thursday, on higher sales of its rheumatoid arthritis treatment Humira and its Hepatitis C drugs, leading the company to raise its full-year earnings forecast.

FILE PHOTO: A screen displays the share price for pharmaceutical maker AbbVie on the floor of the New York Stock Exchange July 18, 2014. REUTERS/Brendan McDermid/File Photo

The company’s shares, which have been under pressure due to setbacks to its drug pipeline, gained about 3.6 percent to $95.22 in late morning trading.

Sales from the company’s Hepatitis C franchise soared to $919 million, easily beating consensus estimate of $572 million, according to brokerage Bernstein.

The revenue rise was fueled by sales of newly approved Mavyret, and comes when the market for Hepatitis C treatments in the United States is steadily shrinking as the impact of the disease lessens. AbbVie said it now expects $3.5 billion in sales from Hepatitis C drugs this year.

The company’s growth in Hepatitis C comes in contrast to Bristol-Myers Squibb Co, which also released earnings on Thursday. Bristol’s hepatitis C franchise all but disappeared with sales of just $3 million.

“We have an asset that will allow us to be able to stay highly competitive and in a leadership position going forward,” AbbVie CEO Rick Gonzalez said about Mavyret on the company’s conference call, playing down concerns about the shrinking market. “We think we have the right tools to be effective over the long term.”

Still, rheumatoid arthritis treatment Humira – the world’s best-selling prescription medicine – brings in nearly two-thirds of AbbVie’s total revenue. Quarterly sales of the drug rose to $4.71 billion, a 20 percent increase from last year.

The company has been aggressively protecting the pricey drug, negotiating with rivals Amgen Inc, Samsung Bioepis and Biogen Inc to fend off U.S. competition from their biosimilars.

AbbVie said it doesn’t expect direct biosimilar competition to Humira in the United States until at least 2022.

Cancer treatment Imbruvica raked in $762 million in sales, just above expectations.

IMPROVED FORECAST

The drugmaker raised 2018 adjusted earnings per share expectation to between $7.66 and $7.76, from between $7.33 and $7.43 previously forecast.

AbbVie said the forecast accounts for an effective tax rate approaching 9 percent this year, following the new U.S. tax law.

On its conference call, AbbVie said that it was going to be investing more aggressively in research and development (R&D) as a result of the tax reform.

But its forecast for 2018 R&D spending as a percentage of its sales is actually down from last year. The company said it expects to spend just over 16 percent of its sales on R&D this year, down from 17.1 percent in 2017.

Net earnings rose to $2.78 billion, or $1.74 per share, in the quarter, from $1.71 billion, or $1.06 per share, a year earlier.

Excluding items, AbbVie earned $1.87 per share, ahead of analysts’ estimate of $1.79.

AbbVie’s net revenue rose 21.4 percent to $7.93 billion, ahead of average estimate of $7.59 billion.

The company also said it would roll out part of a previously announced share repurchase program by May 1, and buy back up to $7.5 billion of stock.

Reporting by Tamara Mathias and Mrinalini Krothapalli in Bengaluru and Michael Erman in New York; Editing by Shounak Dasgupta, Sriraj Kalluvila and Frances Kerry

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EU wants coordinated vaccine push against measles, other diseases

(Reuters) – The European Commission urged EU member states on Thursday to cooperate more closely in fighting diseases such as measles and flu, saying vaccines against them were among the most powerful and cost-effective public health measures.

FILE PHOTO: EU Commissioner for Health and Food Safety Vytenis Andriukaitis gestures after a news conference in Brasilia, Brazil March 29, 2017. REUTERS/Ueslei Marcelino

Setting out the Commission’s plans, health and food safety commissioner Vytenis Andriukaitis said all European Union member states should develop and implement national or regional vaccination plans by 2020 and include in them a target of at least 95 percent coverage for measles.

Data from the European Centre for Disease Prevention and Control (ECDC) show that several EU countries are facing unprecedented outbreaks of measles – a highly contagious disease that can kill.

The ECDC has also warned of a resurgence of other vaccine-preventable diseases because of poor vaccination coverage.

“Infectious diseases are not confined within national borders,” said Andriukaitis. “One member state’s immunization weakness puts the health and security of citizens at risk across the EU. Cooperating in this area is in all of our interests.”

The Commission also called for the introduction of routine checks of vaccination status and regular opportunities for older age-groups to get immunizations in schools and workplaces.

It also proposed establishing a European vaccination information portal to provide objective, transparent and updated evidence online on the benefits and safety of vaccines.

The Commission said it would discuss the proposals with the 28 member states and try to ensure they are adopted as law before the end of this year, with immediate entry into force.

ECDC data show that in the 12 months from March 1, 2017 to Feb. 28, 2018, more than 14,800 measles cases were reported through the European surveillance system.

The ECDC also estimates that at least 40,000 people a year in Europe die from flu, partly due to low vaccine coverage.

Editing by Gareth Jones

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Our new Privacy Manager puts privacy choices at your fingertips

Your privacy is very important. That’s why we have important safeguards in place to protect the information you give us when you visit Medicare.gov. We’ve added a tool that lets you easily control some of the information we may collect from you.

When you visit Medicare.gov, we use common web tools to collect information—things like:

  • What websites you came from
  • What Medicare.gov pages you visit
  • How much time you spend on Medicare.gov
  • What page you’re on when you leave Medicare.gov

We use this information to help us improve Medicare.gov and our outreach to people with Medicare.

You can decide whether you want us to collect this information during your visits to Medicare.gov. Our new Privacy Manager lets you easily adjust your settings to match your comfort level.

To view or change your privacy settings, visit Medicare.gov, and select “Privacy settings” at the bottom of the page. Here’s what it looks like:

Your Privacy Options screengrab

You can choose “on” or “off” for tracking certain types of information about your Medicare.gov visits, like advertising or social media. No matter what you choose, you’ll still have access to everything on Medicare.gov. But, if you choose “off,” we won’t use your visit to:

  • Improve Medicare.gov to make it more useful for visitors
  • Improve our public education and outreach through digital advertising

We’re committed to protecting your privacy. To learn more about how we protect your privacy when you visit Medicare.gov, visit our privacy policy.

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California Lawmakers Seek Reparations For People Sterilized By The State

Rosie Zaballos liked to host playtime tea parties and was sweet to everyone she met. But her older brother worried that the 16-year-old, whom her family described as “a little slow,” might someday become pregnant.

In his 30s and married, he had three kids of his own. And their mom was sick and needed help. So he took Rosie to be sterilized at a state-run hospital so she couldn’t have babies who might place an extra burden on the family.

Rosie never came home. She died during the operation.

This painful history, recounted by Rosie’s niece, Barbara Swarr, was rarely discussed in Barbara’s family when she was growing up in a Spanish immigrant neighborhood in Hayward, Calif., just southeast of San Francisco.

But in the past few years, Swarr, now 70, has pieced together the details of her aunt’s short life and the prevailing attitudes toward immigrants, poor people and those with disabilities that allowed more than 20,000 Californians to be sterilized under the state’s eugenics law — often without their consent — over a 70-year period in the 1900s.

“This was something nobody thought twice about. ‘If they are not all there, if they are Hispanic … make sure they don’t breed these inferiors,’” Swarr recounted with a mix of sadness and bitterness.

Across the country last century, more than 60,000 people deemed unfit to reproduce were sterilized, many against their will or without their knowledge. It was a public health strategy embraced by 32 states under eugenics laws that advocated “better breeding.” It began at state prisons in Indiana and spread to two-thirds of the country, targeting people with mental illness, disabilities and anyone who exhibited “abnormal” behavior.

California abolished its eugenics law in 1979 during Democratic Gov. Jerry Brown’s first term and apologized in 2003 under Gov. Gray Davis, also a Democrat. Legislation under consideration in the state Senate would go a step further to pay reparations, following in the footsteps of North Carolina and Virginia.

The bill, by state Sen. Nancy Skinner (D-Berkeley), would establish the Eugenics Sterilization Compensation Program for the living survivors of state-sponsored sterilization from 1909 to 1979. As currently written, the measure doesn’t specify the amount of state money survivors would receive — a detail that is still being hashed out by lawmakers.

North Carolina lawmakers in 2013 set aside $10 million, and two years later Virginia authorized $25,000 for each victim.

Researchers and advocacy groups estimate that roughly 800 survivors may still be alive today in California, although none have publicly come forward, whether because they’re ashamed of what happened to them or they just don’t realize they were victims.

Skinner said she hopes that publicity surrounding her bill will encourage survivors to come out and speak out.

“We are trying to ensure this is not forgotten,” she said. “It was a completely unjustified wrong that the state authorized and that the state implemented.”

In California, state records described the women who were sterilized as “weak-willed,” “dependent on others” and “feeble-minded.” The reason for their sterilization: Their mental condition was “likely to become transmitted to descendants.”

State law authorized medical superintendents at 12 state homes and hospitals to perform “asexualization” on patients — vasectomies for men and fallopian tube removals for women.

Sonoma State Hospital carried out about 5,000 sterilizations, more than any other place in the country, according to records compiled by Alexandra Minna Stern, a professor at the University of Michigan and an expert on eugenics laws.

Those records also show that Latinas in California were 59 percent more likely to be sterilized than non-Latinas. They were young girls and women who probably didn’t speak English well and ranked low on IQ tests, said Stern, who uncovered the state’s sterilization records in a file cabinet at the Department of Mental Health in Sacramento. In Southern states, African-Americans were targeted for sterilization. In Iowa, it was the poor.

Being Hispanic, black or poor was characterized as a disability in those days, Stern said.

“The way these laws played out, they impacted racial minorities, but it was through the disability lens, which makes it more insidious,” she said.

California historian William Deverell, a professor at the University of Southern California, traces the eugenics laws to a time when social reformers believed they could perfect the human race for the betterment of society — much like agriculturists at the time were trying to perfect avocados or citrus fruits.

“It’s such a fascinating moment because a lot of do-good human types were eugenicists,” Deverell said. “They had this notion they could bring perfection to bear even in the gene pool.”

The hope, historians and advocates say, is that Skinner’s legislation will raise awareness about the sterilizations and the fact that they were little more than a vehicle for state-sanctioned discrimination. They note that these procedures occurred at state facilities as recently as this decade, when doctors sterilized 148 women in California prisons from 2006 to 2010, according to a report by The Center for Investigative Reporting.

The bill requires markers to be placed at the institutions where sterilizations took place, and it calls for the creation of a traveling historical exhibit about eugenics laws.

It’s critical to educate people about this aspect of California’s “dark history,” said Myra Dúran, policy manager for California Latinas for Reproductive Justice, a statewide advocacy group. “It’s important to find the women who were sterilized because it’s important to get their voices heard.”

That’s what Swarr wants for her aunt.

“I honor her by trying to find out about her,” said Swarr, who owns the house where Rosie Zaballos grew up. “I don’t want her to be forgotten. I don’t want her to be just a statistic.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

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Peak Health Plan Premiums Give Rise To Activism — And Unconventional Solutions

CHARLOTTESVILLE, Va. — When Garnett and Dave Mellen sent their 19-year-old daughter, Gita, off to college an hour away at Virginia Commonwealth University last fall, they didn’t expect to follow her.

But in November, the family received notice that its monthly health insurance premium in Charlottesville would triple for 2018, from $1,200 to an unaffordable $3,600.

So, the Mellens, both longtime local business owners, packed their bags and spent time with Gita in her off-campus apartment in Richmond.

“My whole life has been rearranged around trying to get health insurance,” Garnett Mellen, 56, said, as she explained that claiming residency with her daughter in the new ZIP code had cut their premiums by more than half.

Charlottesville now claims the dubious distinction of having the highest individual-market health insurance costs in the country — prompting families like the Mellens to look for extreme solutions.

An exodus of carriers, which was blamed on losses caused by the instability of the Obamacare marketplace, created a coverage vacuum, leaving locals and insurance regulators scrambling.

Only one carrier — Virginia Beach-based Optima Health — decided to continue to participate in the individual market, but it did so with monthly premium increases that were, on average, in the high double-digits and for some consumers as much as 300 percent, according to people interviewed for this story.

It’s a problem that’s likely to be replicated elsewhere, said Timothy Jost, an emeritus professor of law at Washington and Lee University in Virginia and expert on the health law.

“In many states, it’s going to be hard to maintain a functional individual market,” he said. “Charlottesville is sort of ahead of everybody else in this … but this is the direction things are heading.”

Insurers nationwide that intend to participate in the individual market face spring deadlines to file forms for 2019 plans and rate proposals. In Virginia, these dates are April 20 and May 4, respectively.

The situation in Charlottesville has left many residents at their wits’ end about how to pay for their health insurance, prompting the evolution of an angry and rebellious civic movement and thrusting the costs of coverage into the center of local politics.

Charlottesville for Reasonable Health Insurance, a grass-roots organization and Facebook group of more than 700 people, has already claimed small victories in the state legislature, such as propelling the passage of a bill that will alleviate the cost burden for some of its members.

But its highest priority has been pressing state regulators to explain and possibly reconsider the decision that allowed for the stunning premium increase.

In the midst of various bureaucratic fits and starts, the state Bureau of Insurance (BOI) responded to the group April 11 by reiterating that Optima’s rates were “actuarially justified.” Ian Dixon, one of the group’s organizers, said it plans to appeal this finding to the State Corporation Commission.

“We’re not going away, that’s for sure,” said Dixon. “They’re hoping they can wait us out. … They would drag this out for a year if they could.”

At the same time, the group has expanded its focus to other issues on health care costs, such as price transparency and regulatory reform.

When the Mellens found out their monthly health insurance premium in Charlottesville would triple for 2018, from $1,200 to an unaffordable $3,600, they packed their bags and spent time with Gita in her off-campus apartment in Richmond. (Julia Rendleman for KHN)

“My whole life has been rearranged around trying to get health insurance,” Garnett Mellen said. (Julia Rendleman for KHN)

How It Came To This

The trouble started in summer 2017, when the state’s major insurance carriers announced they would be leaving the individual market in Virginia, saying the market was “shrinking and deteriorating” — pointing to the instability of Obamacare under the Trump administration.

Their departures left Albemarle County, home to Charlottesville, bare — meaning residents had no insurance options.

When Optima opted to continue to offer plans in and around Charlottesville, state insurance regulators breathed a collective sigh of relief.

But Optima’s decision came with updated rate increase proposals, which gained the OK of the under-the-gun BOI, led by Commissioner Scott White.

“I think the [regulators] decided they were willing to accept almost anything to get someone to cover Albemarle County and Charlottesville,” Jost said.

About 15 miles north of Charlottesville on U.S. 29, there’s a billboard that some residents now view with bitter irony. It features a smiling man with the message: “I chose Optima.”

On one hand, Optima did fill a void and offer health plans where no other insurer would. Still, many residents found their only choice came with a 300 percent boost in premium costs. They felt that state regulators had fallen short of their consumer-protection responsibilities.

“Any assumption that I had … that I thought [the Bureau of Insurance would be] protecting the people … was completely naive,” said Sarah Stovall, 40, who works for a small software company, lives in Charlottesville with her husband and two sons and has struggled to find affordable coverage.

But Ken Schrad, the director of the Division of Information Resources for the State Corporation Commission, said the bureau is still questioning Optima, checking its math and evaluating its actuarial decisions.

He couldn’t answer specific questions about a matter he said is pending.

Schrad said the bureau reached out to carriers and worked with them last summer when it was clear that much of the commonwealth wouldn’t be covered.

“It wasn’t a question of what the premiums would be,” Schrad said. “It was whether there would be any coverage.

“[Filings] must be based on actuarially sound decisions, and that’s all the bureau can review. The market is the market.”

A Movement Is Born

Stovall, 40, teamed up with Dixon, 38, a web app developer, to manage the emerging Facebook group, which was originally set up as a support system for people in search of new insurance options in a short window of time. Soon, Karl Quist, 46, who had been actively calling the BOI to lodge complaints, joined the effort.

“The three of us did not know each other before November,” Dixon said. “We feel like we’re relatives now.”

Others quickly piled on, including the Mellens and Gail Williamson, 64, a part-time secretary at a private school who needed insurance for herself and her husband, who owns a business restoring antiques.

Like many of the people in the group, the Williamsons made too much money to qualify for federal subsidies, but too little to be able to afford the $3,725 monthly premium that Optima would have charged them.

Sharing their knowledge, many Charlottesville for Reasonable Health Insurance members have resorted to imperfect jury-rigged policies that do not come with many of the coverage guarantees that protect patients from unexpected costs under the Affordable Care Act.

Instead of paying $2,920 a month for Optima’s least generous family health plan, Quist is saving $2,300 a month by purchasing two non-ACA-compliant plans, one for sickness and one for accidents.

Williamson has settled on a “silly little” three-month policy for $1,400 per month, plus an extra $35 a month in supplemental accident insurance for her husband.

“If I won the lottery, the first thing I’d do before giving my kids any money would be to buy health insurance for everyone in that group,” Williamson said.

Washington and Lee’s Jost said he worries about the impact of such cobbled-together coverage.

He said having these plans could damage the ACA market further by skimming the healthier people away from the more comprehensive coverage, leaving behind those who are ill or have chronic conditions.

“It makes the situation worse because the only people who are going to pay premiums that high are people who are desperate,” Jost said.

For Charlottesville resident Garnett Mellen (right), finding a way to cut her steep health insurance premiums involved spending more time at daughter Gita’s off-campus college apartment in Richmond. (Julia Rendleman for KHN)

Forward Motion

Over the past months, the community-based effort has evolved beyond being an ad hoc information clearinghouse into a powerful organizing tool.

For instance, it has raised almost $20,000 to hire lawyer Jay Angoff, a former federal and state insurance official, to appeal to Optima and state regulators about the Charlottesville-area rates.

Dixon, Stovall and Quist also regularly pile into Stovall’s minivan, drive to Richmond and become lobbyists for their cause.

“The insurance companies pay people very good money to lobby for them on a regular basis,” Stovall said. “Meanwhile, I have to take off work, Ian [Dixon] has to leave his business for a day.”

“On some level, I have faith that if we keep pushing, I don’t know what the eventual outcome will be, but we’ll find some type of justice,” Dixon added.

Their greatest victory came with the passage of SB 672. This law redefined what a “small employer” is so that self-employed people can buy insurance in the small-group market.

The group sought this change because many people, including Dixon, found that the cost of adding an employee to a company of one allowed them to save money by obtaining insurance as a small group, though it still added significant overhead costs to these businesses.

Many in the group see this success as only a band-aid fix. Though it allows some people to obtain cheaper insurance, it doesn’t address the root of the problem: Optima’s rate increases.

For Garnett Mellen, though, the issue seems resolved, at least for now. She found a job with health benefits in Charlottesville, which enabled her and her husband to move back there.

It’s a big relief — both for her and for Gita, her college-aged daughter.

“She [was] not entirely happy with us being there,” Mellen said.

Related Topics

Cost and Quality Health Industry Insurance States The Health Law

Insurers Premiums Virginia

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Novartis’ digital drive continues with eye-disease app

ZURICH (Reuters) – Novartis’s foray into digital technology intensified on Wednesday as the Swiss drugmaker launched a mobile-phone based app to help collect data from people participating in eye disease studies.

FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo

It is using Apple’s ResearchKit for its “FocalView” application to help researchers track ophthalmic disease progression by collecting data directly from patients without requiring them to travel to a doctor.

As Chief Executive Vas Narasimhan focuses the Basel-based company on innovative medicines via acquisitions like this month’s $8.7 billion takeover of U.S.-based AveXis, he is also plowing resources into digital technology in a bid to boost trial success, save time and cut costs.

In March, Narasimhan announced separate plans for up to 10 remote clinical trials by 2022 using U.S. partner Science 37’s mobile technology.

“Optimizing digital technology in research and development, particularly in ophthalmic disease, could have a marked impact on the quality of the data we capture,” Bertrand Bodson, who as chief digital officer was elevated to Novartis’s executive committee this year, said in a statement.

“We believe apps like FocalView…can help accelerate the development of treatments.”

Since patients with eye problems may face mobility issues, Novartis said this app could reduce the hassle of collecting reliable data.

Apple’s ResearchKit is an open-source software tool designed to give scientists a new way to gather information on patients by using their iPhones. Several top research institutions have already developed applications, including Stanford University School of Medicine and Weill Cornell Medical College. [reut.rs/2JodvEF]

Reporting by John Miller; Editing by Michael Shields

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U.S. court upholds dismissal of $200 million Merck verdict against Gilead

(Reuters) – A U.S. appeals court on Wednesday affirmed a ruling that pharmaceutical company Merck & Co dishonestly obtained patent rights and was not entitled to collect a $200 million infringement verdict it won against rival Gilead Sciences Inc.

The U.S. Court of Appeals for the Federal Circuit upheld a June 2016 ruling that the two Merck patents, which cover methods of treating Hepatitis C, were unenforceable because of a pattern of misconduct by the company, including lying under oath by one of its in-house lawyers.

A Gilead spokesman said the company was very pleased with the ruling and believe it was “justified and well supported by the record.” 

Merck did not immediately provide a comment on the decision.

Direct-acting anti-virals, such as Gilead’s Sovaldi and Harvoni, have revolutionized treatment of Hepatitis C, with cure rates of more than 90 percent. The viral disease is estimated to infect about 3.2 million Americans and can lead to liver failure.

A jury in federal court in San Jose, California, awarded Merck $200 million in March 2016 after finding Sovaldi and Harvoni infringed two of its patents.

A judge threw out the verdict later that year, ruling the patents were unenforceable based on the company’s conduct. She noted that, in the process of applying for one of the patents, Merck used confidential information it obtained in 2004 while discussing a possible partnership with Pharmasset Inc, a company Gilead bought in 2011.

The judge also said a Merck in-house lawyer testified untruthfully in a deposition and at trial about his participation in a confidential call with Pharmasset personnel.

Merck appealed the ruling, saying there was no “deliberately planned and carefully executed scheme by Merck to defraud or deceive.”

But the appeals court said in Wednesday’s ruling that the lower judge had sufficient reason to conclude that the Merck patents were “tainted” by misconduct and should not be enforceable.

In February a federal judge in Delaware overturned a different jury verdict requiring Gilead to pay $2.54 billion for infringing another Merck patent relating to the hepatitis C drugs.

The verdict had been the largest ever in a U.S. patent case, but the judge ruled Merck’s patent was invalid because it did not meet a requirement that it disclose how to make the treatment it covered without undue experimentation.

(This story has been refiled to correct paragraph seven to she instead of he in reference to lower court judge.)

Reporting by Jan Wolfe; editing by Jonathan Oatis

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