Malware Attacks On Hospitals Put Patients At Risk

Hackers crippled computer systems at several MedStar hospitals, including the Georgetown University Hospital in Washington, D.C.

Hackers crippled computer systems at several MedStar hospitals, including the Georgetown University Hospital in Washington, D.C. Molly Riley/AP hide caption

toggle caption Molly Riley/AP

The first sign seems innocuous enough if you don’t know what you’re looking at: Files in the computer appear as decrypt.html, or decrypt.txt instead of their usual names.

Then, you click. A box pops up that gives you an ultimatum: Want the file? You’ll have to pay up, and probably in bitcoin.

That is what happened at U.S. hospitals in the past month in California, Kentucky, Maryland and the District of Columbia. The malware attacks have left the 14 hospitals — 10 of which are part of the MedStar hospital group — unable to access patient data and, in some cases, having to turn patients away.

Hospitals are not alone in their vulnerability; last month, a cafe in Maryland was hit with a ransomware attack. In another instance, Mac computers were targeted. Last year, police in Massachusetts paid hackers to return access to their data. Companies and individuals in the U.S. lost more than $24 million to ransomware in 2015, according to the FBI.

And in February at the Hollywood Presbyterian Medical Center in Los Angeles, administrators paid the asking price of 40 bitcoin, about $16,664 at the time, to regain access to their data. At MedStar, the hospital is being asked to pay 45 bitcoin.

Several MedStar employees saw a message on their computer screens: “You just have 10 days to send us the Bitcoin. After 10 days we will remove your private key and it’s impossible to recover your files.”

“The big difference with health care is that the consequences are greater,” Kevin Fu, an associate professor at the University of Michigan who studies computer security issues in hospitals, told the MIT Technology Review. “You can lose your email and that’s annoying, but patient records are needed in order to treat patients.”

Though bitcoin is not in itself a driver of cybercrime, it allows the hackers to have instant access to the money without its having to go through a bank or credit card. Peter Van Valkenburgh, director of research at Coin Center, a nonprofit dedicated to digital currency advocacy, explains that often the ransomware will include easy-to-follow instructions on how to quickly access and trade bitcoin.

Hospitals hit by the attack felt the pressure of being without patient information. At a MedStar hospital, a patient was given an antibiotic that, a nurse told the Washington Post, “should have been stopped eight hours earlier.” At the Hollywood Presbyterian Medical Center last month, patients were diverted to other hospitals. In both situations, the hospitals returned to paper records.

On its website Thursday, MedStar posted: “MedStar Health’s priority continues to be providing high quality, safe patient care, as we work to fully restore all of our major IT systems. Our doors remain open, with a few exceptions. With the dedication and commitment of our clinicians and associates, we are thankful that we have been able to perform more than 1,000 surgeries since Monday morning’s malicious malware attack.”

Rick Pollack, president and CEO of the American Hospital Association, emphasizes that hospitals should take steps to protect patient data: “Hospital leaders are using the lessons learned in previous attacks and are applying best cybersecurity practices shared by the AHA in an effort to anticipate and respond to existing and emerging threats,” he says.

The FBI is investigating several of these recent attacks. An FBI official tells NPR:

“Companies can prevent and mitigate malware infection by utilizing appropriate backup and malware detection and prevention systems, and training employees to be skeptical of emails, attachments, and websites they don’t recognize. The FBI does not condone payment of ransom, as payment of extortion monies may encourage continued criminal activity, lead to other victimizations, or be used to facilitate serious crimes.”

Hospitals can take a variety of steps to safeguard against these kinds of attacks, like using HTTPS encryption, two-factor authentication and implementing file backups on a separate server. “For hospitals right now, backups of customer data on unconnected machines or machines in other networks is essential,” Van Valkenburgh says.

He adds that patients should have more control over who has access to their personal records, and when. But until then? “We really are at the mercy of these centralized institutions,” he says.

Naomi LaChance is a business news intern at NPR.

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How A Painkiller Designed To Deter Abuse Helped Spark An HIV Outbreak

Opana pills, seen in 2010, before Endo Pharmaceuticals changed the formula in a move intended to deter abuse.

Opana pills, seen in 2010, before Endo Pharmaceuticals changed the formula in a move intended to deter abuse. Tom Walker/Flickr hide caption

toggle caption Tom Walker/Flickr

When Kevin Polly first started abusing Opana ER, a potent prescription opioid painkiller, he took pills — or fractions of pills — and crushed them into a fine powder, then snorted it.

When Opana pills are swallowed, they release their painkilling ingredient over 12 hours. If the pills were crushed and snorted, though, the drug was released in a single dose.

“Just think about it,” Polly says, “12 hours of medicine, and, ‘BAM!’ you’re getting it all at once.”

But the drug’s manufacturer, Endo Pharmaceuticals, reformulated Opana in 2012. The new pills featured a coating that was intended to make them more difficult to abuse by crushing them into powder or dissolving them.

Polly discovered he could no longer snort the medicine in the pill, to which he had become addicted. But he and other Opana users soon found a way to remove the drug’s hard coating and receive Opana’s powerful dose all at once: injection.

Polly says he used to inject Opana as many as five times a day. He often shared needles with other people.

He says he never anticipated what would happen next. In early 2015, Polly tested positive for HIV. “It was devastating news,” he says.

Kevin Polly is among the 190 people in Indiana’s Scott County who have tested positive for HIV since early 2015, in the largest HIV outbreak in Indiana history.

The Change To Opana That Was Intended To Prevent Abuse

For its part, Endo has said that its decision to reformulate Opana was a well-intended attempt to prevent abuse. As the company told the Food and Drug Administration in 2012, Endo reformulated the drug “to provide a crush-resistant product, equally as effective as Opana ER, which would discourage abuse, misuse and diversion.” Endo declined repeated requests from NPR for an interview.

According to study data, as well as interviews with Indiana residents addicted to Opana, the reformulation effectively deterred many people from snorting the drug. But the change also led a significant number of people to abuse the drug by injection. When needles are shared, the injection route can transmit HIV, hepatitis C or other infections.

And interviews with experts, court filings, documents from the FDA, as well as Endo’s own statements, suggest the company’s decision to reformulate Opana was also motivated in large part by financial interests.

Public health experts say “abuse deterrent” drugs may serve a role in reducing what the Centers for Disease Control and Prevention calls a national epidemic of prescription opioid abuse. The FDA and members of Congress have also supported their development. But the experience with Opana’s reformulation may serve as a cautionary tale for the potential effects of “abuse deterrent” drugs.

Experiences In Austin, Ind.

While NPR’s Kelly McEvers and I were reporting in Austin, Ind., people who abused Opana and were familiar with changes to the drug’s formula told us similar stories.

“The pharmaceutical company, they changed it so you can’t crush them and snort them,” said Devin, a 26-year old. “Whenever they done that, that’s when everybody started shooting them.”

Jeff, a veteran of the Army National Guard, said he became addicted to Opana after being prescribed opioid painkillers for a back injury he sustained in Iraq.

At some point, Jeff said, he began crushing and snorting pills. Then, he said, the company “reformulated them, and the only way you could do them is to inject them.”

Joy, a former registered nurse who got addicted to opioids after a back injury, said that she initially stopped using Opana after the reformulation. But that didn’t last long. “Some genius figured out, ‘Hey we can cook this down and turn [it] into a liquid and shoot it up,’ ” Joy said. “And then it took off like wildfire after that.”

(NPR is withholding Devin’s, Jeff’s and Joy’s last names to protect their privacy.)

Because of the coating added to Opana, the process of preparing it for injection does take a little work. But in the end, it’s not that difficult.

My colleague Kelly watched people prepare Opana for injection, using just the bottom of a soda can, a small lighter, a cigarette filter and tap water.

Behind The Reformulation, Public Health And Business Considerations

So why did Endo Pharmaceuticals reformulate the drug in the first place?

Volunteers search for used needles near Rural Street in Austin, Ind. Scott County, in southeastern Indiana, experienced the worst outbreak of HIV in the state's history after people began injecting the prescription painkiller Opana.

Volunteers search for used needles near Rural Street in Austin, Ind. Scott County, in southeastern Indiana, experienced the worst outbreak of HIV in the state’s history after people began injecting the prescription painkiller Opana. Seth Herald/NurPhoto/Corbis hide caption

toggle caption Seth Herald/NurPhoto/Corbis

The answer involves both public health concerns and business considerations.

Endo Pharmaceuticals released Opana in 2006. Taken orally, Opana is about twice as powerful as OxyContin, and the company says it is “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.”

Soon afterward, though, communities around the country began reporting abuse of Opana and even overdose deaths.

Endo said those concerns over public health and abuse were key motivations to reformulate the drug. Opana also was a major moneymaker for the company.

In 2011, for example, Opana generated $384 million in net sales for Endo, accounting for 14 percent of the company’s total revenue that year.

But the company also faced the threat of generic competition.

So Endo developed a strategy that would block its competitors and maintain Opana’s share of the market.

The company reformulated the drug, this time with features designed to prevent abuse, a move that could potentially protect Endo at a time it faced the loss of patent protection.

The FDA approved Endo’s reformulated Opana, and in 2012 the company began replacing the old versions of Opana on pharmacy shelves.

In August of that year, Endo took another step. The company filed a petition with the FDA, arguing that it had removed the old, crushable version of Opana from the market “for reasons of safety or effectiveness.” It also asked the agency to “refuse to approve” and “suspend and withdraw the approval” of generic, noncrush-resistant versions of Opana.

If the FDA agreed with Endo, the agency would effectively eliminate the company’s generic competition.

“We see this again and again in the pharmaceutical industry,” says Dr. Anna Lembke, an assistant professor of psychiatry at Stanford University Medical Center. “They come up with some new fancy formulation of basically the same old drug … and then that way they have a new drug that they can charge a lot of money for.”

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For example, in 2010, Purdue Pharma reformulated its popular opioid painkiller OxyContin to make the drug crush-resistant. The FDA later determined that the reformulated version of OxyContin was significantly safer and that “the benefits of original OxyContin no longer outweigh its risks.”

The agency then blocked generic, noncrush-resistant versions of OxyContin. Dr. Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing and a prominent critic of the drug industry, says this type of decision “is worth billions to a pharmaceutical company.”

Business Concerns Versus Public Health

Endo’s financial motivations for reformulating Opana were suggested in court filings.

A reformulated OxyContin pill (left) releases its active ingredient over time, but an added polymer makes it difficult to crush, melt or prepare for injection. When heated, the polymer forms a viscous gel that binds the active ingredient.

A reformulated OxyContin pill (left) releases its active ingredient over time, but an added polymer makes it difficult to crush, melt or prepare for injection. When heated, the polymer forms a viscous gel that binds the active ingredient. Science Source hide caption

toggle caption Science Source

In 2012, while Endo’s petition was pending FDA’s decision, the company filed a lawsuit in U.S. District Court for the District of Columbia to compel the agency to speed up the review.

Endo’s lawyers predicted a “spike of misuse and abuse” if generic — and noncrush-resistant — versions of Opana hit the market.

But the company also acknowledged its business interests.

In a signed declaration, Julie H. McHugh, then the chief operating officer at Endo, said that if a generic version of Opana entered the market, “annualized net sales will decrease by an amount up to $135 million.”

The loss in sales, McHugh stated, “could result in the termination of up to 150 employees and contractors employed by Endo.”

The FDA said that profits — not public health – were behind Endo’s impatience.

“Endo’s true interest in expedited FDA consideration stems from business concerns rather than protection of the public health,” lawyers for the agency stated in a legal filing.

FDA Finds Opana Reformulation Not Significantly Safer

On May 10, 2013, the FDA rendered its decision, concluding that reformulated Opana didn’t effectively deter abuse. The decision opened the door to Opana’s generic competitors, and that day the price of shares in the company dropped more than 5 percent.

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Opana was still safe and effective when appropriately prescribed, the FDA said.

But the agency said, “study data show that the reformulated version’s extended-release features can be compromised when subjected to … cutting, grinding, or chewing.” The FDA also determined that “reformulated Opana ER can be readily prepared for injection.”

Significantly, the agency warned that preliminary data about how the drug was being abused suggested “the troubling possibility that a higher percentage of reformulated Opana ER abuse is via injection than was the case with the original formulation.”

Unintended Consequences

By the time the FDA concluded that reformulated Opana didn’t effectively deter abuse, warning signs had already appeared.

In October 2012, the CDC issued a health alert, saying a “cluster of at least 12 patients” in Tennessee had contracted thrombotic thrombocytopenic purpura, a rare blood-clotting disorder, after injecting reformulated Opana. (The number of patients later rose to 15.)

In a conference call with investors on Feb. 28, 2013, Endo officials were asked about the reports of injection abuse. “We’ve designed the Opana crush-­resistant formulation to be crush­-resistant, to avoid primarily the nasal root of abuse,” said Ivan P. Gergel, who served as Endo’s chief scientific officer at the time. Gergel didn’t say whether intravenous abuse was considered in developing the drug’s reformulation.

“Clearly, we are looking into this data,” Gergel went on to say, “but it’s in a very, very distinct area of the country.”

Subsequent analyses of drug abuse data appear to contradict Gergel’s claim and support the FDA’s concerns about injection abuse.

One study from 2014, co-authored by an Endo medical director, drew from data collected at drug treatment centers around the U.S. Overall abuse of Opana had dropped following reformulation, the authors found. But injection had become the preferred way of abusing the drug.

According to the study, 64 percent of people abusing reformulated Opana were injecting the drug, between October 2012 and March 2014. By comparison, 36 percent of people abusing the noncrush-resistant versions of Opana did so by injection.

“With the reformulation, snorting appears to be much, much lower, whereas injection appears to be the more preferred route,” Theresa Cassidy, the study’s lead author, told NPR in a phone interview. Still, Cassidy, a vice president of analytics at a company called Inflexxion, warns that it’s not possible to draw a causal link between the reformulation and injection abuse based simply on these data.

(Inflexxion is paid by pharmaceutical companies, including Endo, to conduct research into drug abuse patterns but says it maintains independence.)

A separate study also looked at abuse data before and after Opana’s reformulation. Though the sample size was small, the study found “a trend toward increases in IV [intravenous] use after the reformulation.”

Endo’s Response

NPR asked Endo for an interview related to abuse issues of Opana and the company’s decision to reformulate the drug.

“Patient safety is a top priority for Endo and we are committed to providing patients with approved products that are safe and effective when used as prescribed,” the company said in a statement in response. “We are dedicated to providing quality medications for the treatment of patients diagnosed with chronic pain as well as to addressing opioid misuse and abuse.”

While declining an interview, Endo directed NPR to contact the Center for Lawful Access and Abuse Deterrence, a nonprofit organization that advocates for the development of prescription drugs with abuse-deterrent technology. “I think that you’ve got a problem where the product isn’t able to deter all forms of abuse,” says Mike Barnes, the executive director of CLAAD. “But to the extent that it’s possible to avoid inhalation, for example, the snorting, that has a benefit.”

CLAAD receives support from major pharmaceutical companies, including Endo, but the organization says its policymaking process is independent.

Re-evaluating Abuse-Deterrent Technology

The FDA has called the development of abuse-deterrent drugs a “high public health priority.” In response to this story, agency spokeswoman Sarah Peddicord tells NPR in an email, “The FDA is very concerned about potential unintended consequences of abuse-deterrent opioids (and purportedly abuse-deterrent opioids) and it is something we are actively looking at.”

The Food and Drug Administration has encouraged drugmakers to take steps to deter abuse of opioid medicines. But the agency hasn't agreed that all the changes are effective.

The Food and Drug Administration has encouraged drugmakers to take steps to deter abuse of opioid medicines. But the agency hasn’t agreed that all the changes are effective. Andrew Harnik/AP hide caption

toggle caption Andrew Harnik/AP

Peddicord reiterated the FDA’s decision not to approve abuse-deterrent labeling for Opana, and says it is continuing to monitor the five drugs the agency has approved as abuse-deterrent.

“FDA is requiring all sponsors of opioids with approved abuse-deterrent labeling to conduct long-term epidemiological studies to assess their effectiveness in reducing abuse in the real world,” says Peddicord. “Abuse-deterrent does not mean abuse-proof.”

The idea of deterrence could give doctors and patients a false sense of security, since the underlying opioid is just as addictive, some experts warn.

“The two most important things that we can do to address the opioid epidemic are to prescribe fewer opioids, and to get patients with opioid addiction into treatment,” says Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. “And there’s no evidence to suggest that abuse-deterrent formulations are going to fundamentally change the shape of the opioid epidemic.”

Endo Continues To Seek Abuse-Deterrent Status For Opana

Despite the well-publicized accounts of abuse in Indiana and Tennessee, Endo continues to push for FDA labeling that would call reformulated Opana ER “abuse-deterrent,” because of its apparent effect on abuse by snorting.

In a call with investors on Feb. 29, 2016, President and CEO Rajiv De Silva said that, for the most part, “If we are successful in getting that relabeling, it will certainly serve to help remove all the generics from the market.”

Endo’s push for relabeling may face additional scrutiny because of ongoing legal inquiries. In February, the New York attorney general said Endo engaged in “deceptive and unlawful conduct” in its marketing of Opana and imposed a $200,000 penalty on the company.

The company’s statement to NPR said, “The settlement does not include any agreement or confirmation by Endo that its marketing practices were inappropriate.”

On Thursday, the Federal Trade Commission also announced a lawsuit filed in U.S. District Court for the Eastern District of Pennsylvania against Endo alleging that the company violated antitrust laws and illegally blocked access to generic versions of Opana. Endo says in a statement, “We believe the FTC’s case is without merit and Endo intends to vigorously defend itself in the litigation.”

Back in Austin, Ind., local, state and federal law enforcement have struggled to eliminate Opana from the town’s illegal-drug market.

A recent drug bust helped reduce the amount of Opana available on the street.

But drug users there still describe Opana as the most desirable drug around.

A single Opana pill, they say, now costs about $200, up from around $140 when we started reporting this story.

Side Effects Public Media health reporter Jake Harper and NPR’s Kelly McEvers contributed to this story.

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On The Rise: Workers' Desire For Raises Over Health Benefits

More cake, please.

More cake, please. Illustration Works/Corbis hide caption

toggle caption Illustration Works/Corbis

Fatter paychecks, slimmer health insurance.

A recent survey found 1 in 5 people with employer-based coverage prefer fewer health benefits if it would mean a bump up for wages. That’s double the proportion who said they’d make that choice in 2012.

“I do these surveys all the time, and it’s rare where you see things change that quickly,” said Paul Fronstin, director of the health research and education program at the Employee Benefit Research Institute, which conducted the survey of 1,500 workers with Greenwald & Associates.

Fronstin speculated that worker frustration with low wage growth may be driving the shift in attitudes.

Wage and salary increases have hovered around 2 to 3 percent in recent years, generally rising more slowly than cost increases of annual health care benefits.

Overall, two-thirds of people with employer-sponsored coverage reported that they were satisfied with their health insurance benefits in 2015, the survey found, lower than the 74 percent satisfaction figure in 2012. Meanwhile, the percentage of people who would accept a smaller paycheck for better health insurance benefits was 14 percent last year, essentially unchanged from 15 percent three years earlier.

The growing willingness to trade health benefits for wages may be linked to some degree to the millennial generation’s growing share of the workforce, Fronstin said, referring to people born between roughly 1980 and 2000.

“The younger you are the less important health insurance is to you,” Fronstin said. As baby boomers retire and younger workers move in behind them, it may affect the mix of benefits that employers offer. But as today’s “young invincibles” age, chances are they’ll see more value in their health insurance and the pendulum will swing back again, according to Fronstin.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Michelle Andrews is on Twitter:@mandrews110.

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Industrial Science Hunts For Nursing Home Fraud In New Mexico Case

State attorneys allege that the Casa Real Health Center, a Santa Fe nursing home, is one of six facilities that billed Medicaid and private insurers for services they couldn't have delivered, given their low staffing levels.

State attorneys allege that the Casa Real Health Center, a Santa Fe nursing home, is one of six facilities that billed Medicaid and private insurers for services they couldn’t have delivered, given their low staffing levels. Ina Jaffe/NPR hide caption

toggle caption Ina Jaffe/NPR

One of the keys to providing good care in nursing homes is simply having enough staff. The federal government says about a quarter of all nursing home complaints can be traced back to low staffing levels. And studies have connected low staff levels to lousy treatment. The state of New Mexico connects it to fraud.

The state’s Attorney General is suing a chain of nursing homes, alleging that the facilities were so severely under-staffed, they couldn’t possibly have provided the care they charged for. Now New Mexico wants its money back.

Lino Lucero is “confidential witness #1” in the lawsuit. In 2007 he and his wife Linda made the tough decision to send Linda’s mother, Polly Duran, to a nursing home. Alzheimer’s continued to tighten its grip on Duran, and they’d done everything they could for her at home.

“It got to the point where it was making my wife sick trying to deal 24 hours a day with her,” says Lucero.

So he and his wife brought his mother-in-law to a nursing home in Santa Fe called Casa Real. They visited frequently, sometimes daily. There were always appalling discoveries.

Lucero almost apologizes for describing the conditions there. “Not to be a distasteful person,” he says, “but the smell and the stench… not only from her, but from the other residents that were there, was horrible and deplorable. You’d walk in and you’d wish you had a mask.”

Linda Lucero frequently cleaned her mother up and changed her sheets. The Luceros also noticed that Duran was losing weight and growing frail. Even though the doctor had told the staff that Duran needed to have her food cut into bite-size pieces, they did not always do so. So sometimes, she didn’t eat.

The last straw was when the Luceros got a call from a hospital in Santa Fe. The doctor on the phone said that Duran had just been admitted.

It turned out she’d broken her hip. Lucero says the physician told him that “it’s severely broken and it looks like it’s been broken for more than three or four days.”

The Luceros never found out how Duran broke her hip or why it took the staff at Casa Real three days to do something about it. She never walked again and died several months later.

Her experience is the reason that Lino Lucero decided to become a witness in New Mexico’s lawsuit against Cathedral Rock, the corporation that owned the nursing home then, and Preferred Care Partners Management Group, which owns it now.

“These are companies that profited and made hundreds and hundreds of millions of dollars in revenue,” about 80 percent of which came from the state of New Mexico in the form of Medicaid payments, says Hector Balderas, New Mexico’s attorney general.

In addition to Casa Real, there are six more nursing homes owned by Preferred Care Partners Management Group that are targets of this suit. “We’re trying to recover dollars back for the taxpayers of New Mexico,” says Balderas. The state is also trying to recover funds on behalf of private-pay residents.

But Balderas says that, more than money, the lawsuit is about the elderly and disabled residents of nursing homes “who suffered unnecessarily, sitting there in their own feces, sitting there in urine, developing bed sores. And some of this lack of care even resulted in death.”

So far, there are 31 confidential witnesses in this case — former nursing home employees as well as families like the Luceros. But what makes New Mexico’s suit novel, isn’t the personal accounts. It’s the data the state gathered to support its argument .

State attorneys used time and motion studies – a concept borrowed from industrial engineering — that show how long it takes health care staffers to do individual tasks. They focused on activities considered “basic care,” such as bathing, feeding, and turning residents so that they don’t get bed sores.

The attorney general’s office then compared those findings with the care required by the actual residents of the targeted nursing homes. The conclusion? It was physically impossible for the number of people employed at these nursing homes to provide the care required by the residents. So when the nursing homes billed for that care, they were lying.

But defense attorney Deborah Mann argues that that formula “reinvents the wheel.” She’s representing Preferred Care Partners Management Group in the lawsuit.

There’s already an established legal standard of care in New Mexico, says Mann. It’s 2 ½ hours of nursing care per resident per day, on average.

“That’s the standard that was published to the industry,” says Mann. “That’s the standard that the people who ran the nursing homes knew about. And to try to hold somebody in retrospect liable — for essentially lying — is unfair.”

Balderas counters that simply following regulations is not enough.

“Those are minimal standards, just a basic floor. They should be doing everything they can to make sure that the health, safety and welfare of these residents is met,” says Balderas, echoing the federal standards for nursing homes.

Deborah Mann also objects to the role of private attorneys in this lawsuit. The firm of Cohen Milstein, based in Washington, D.C., approached Balderas’ predecessor in the New Mexico Attorney General’s office, Gary King, with the idea of filing a suit against nursing homes for insufficient staffing.

“We don’t know how it turned into something against our clients,” Mann says, calling the whole arrangement “inappropriate.”

Balderas says that while he didn’t originate the case, he decided to pursue it “because it ties directly to our mission in protecting vulnerable populations and families in New Mexico.” Meanwhile, his office can rely on the resources of Cohen Milstein attorneys, paralegals, and investigators, who only see a big payday if the state wins the case.

Such collaborations are not uncommon. Private firms can bring more firepower to a case than government agencies. Critics call the arrangements “pay to play,” noting the campaign contributions that firms like Cohen Milstein make to state attorneys general around the country. Public records suggest Balderas’ campaign fund received $5,000 from Cohen Milstein, far from his largest contribution. In addition, individual Cohen Milstein attorneys donated several thousand dollars more.

Attorneys for the other defendant, Cathedral Rock, declined to comment to NPR. But that company previously settled federal civil and criminal complaints for negligence and fraud in its Missouri nursing homes, paying more than $1.6 million in fines. As for Preferred Care Partners Management Group, all but one of their nursing homes targeted in this suit have received bad grades on a federal site that rates nursing homes.

Now, years after Polly Duran’s death, her son-in-law still wants the nursing home held accountable for the way it treated her.

It’s amazing, he says, that you can put your trust in the nursing home to care for someone you love and then, through neglect and abuse, “their spirit is completely broken and lost.”

The pain of witnessing that happen to Polly Duran, Lucero says, will stay with him for life.

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Study: Prolonged Antibiotic Treatment Gave No Relief For Lasting Lyme Symptoms

A bite from a blacklegged tick can transmit Borrelia burgdorferi bacteria, which cause Lyme disease.

A bite from a blacklegged tick can transmit Borrelia burgdorferi bacteria, which cause Lyme disease. Jim Gathany/CDC hide caption

toggle caption Jim Gathany/CDC

For some people with Lyme disease, the illness seems to take a lasting toll.

Years after a standard two-week course of antibiotics against Borrellia burgdorferi or closely related organisms that cause the disease, these patients remain exhausted and foggy-headed. They suffer from chronic aches and pains and poor sleep.

In the last decade and a half, medical societies and some patient groups have fought over how to treat these people and also over the reasons why they don’t get better.

Some doctors and guidelines recommend long-term antibiotic treatment for these Lyme disease patients. The National Institutes of Health and the Infectious Disease Society of America maintain, however, that prolonged antibiotics use doesn’t help, and advise doctors to limit antibiotics to the initial course.

Results from a clinical trial published Wednesday in the New England Journal of Medicine support the recommendation against long-term antibiotic treatment. Researchers in the Netherlands randomly assigned 281 people with persistent symptoms who had been diagnosed with Lyme disease to three groups. First, though, all the people were treated with antibiotics for two weeks. Then, a third got a placebo, a third got one kind of antibiotic and the remaining third got different antibiotics for a period of three months.

At the end of the trial, no group of patients did better than the other. “They were not helped by prolonged antibiotic treatment,” says Dr. Bart-Jan Kullberg, a senior author on the study and an infectious disease researcher at Radboud University in the Netherlands.

The study already has detractors. “You do a lousy study that’s designed to fail, and you get a failed study. And that’s basically what this is,” says Dr. Raphael Stricker, a board member of the International Lyme and Associated Diseases Society , or ILADS, which advocates for the long-term use of antibiotics therapy.

There have been four other clinical trials, funded by the NIH, that have come to the same conclusion as Kullberg’s study and none suggested long-term antibiotics helped. But Stricker says the studies didn’t test enough people, use a sufficiently aggressive antibiotic regimen or continue therapy long enough to eradicate persistent, hidden Borrellia infections.

Those arguments don’t wash with Dr. Paul Auwaerter, an infectious disease specialist at the Johns Hopkins University School of Medicine. Even if there is a persistent infection, Auwaerter says, “It doesn’t look like the extra antibiotics help them improve any faster.” Instead, Auwaerter says the needless use of the drugs raises the risk of developing antibiotic resistance in bacteria and other infections in individual patients. “There’s a growing interest to reserve [antibiotics] for times they truly have documented benefit rather than conjecture.”

Auwaerter says Kullberg’s study is well done, and its critics are ignoring scientific evidence. “The notion that the infection is difficult to eradicate with antibiotic therapy is not well supported by scientific evidence,” he says. In a 2011 editorial in The Lancet Infectious Diseases, Auwaerter and coauthors criticized organizations including ILADS of creating “a parallel universe of pseudoscientific practitioners, research, publications and meetings.”

A characteristic bull's-eye rash indicating Lyme disease.

A characteristic bull’s-eye rash indicating Lyme disease. Dr. Kenneth Greer/Visuals Unlimited/Getty Images hide caption

toggle caption Dr. Kenneth Greer/Visuals Unlimited/Getty Images

There are theories about why some Lyme patients struggle long after they’ve been treated that don’t involve an obstinate colony of Borrellia bacteria. “There’s no simple answer,” Kullberg says. “It could be residual damage due to the infection. It could be an ongoing immunological response. There are a large number of hypotheses for why patients have persistent severe symptoms.” Basically, he says, doctors don’t know why these patients are still sick.

Stricker argues that that mainstream professional societies are ignoring these patients’ needs. “They’re horribly sick,” he says. “They need decent treatment. Unfortunately, this study is going to be misinterpreted to say there is no treatment for these patients.”

But Auwaeter says the reason why these patients are still sick is complicated, and treatment shouldn’t involve antibiotics for months or years. “It’s unnerving to both physicians and patients because nobody likes having something that we don’t understand.” He says the message that patients just need more antibiotics is appealing, but that it represents a false hope.

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Big Financial Costs Are Part Of Alzheimer's Toll On Families

Paul Hornback was a senior engineer and analyst for the U.S. Army when he was diagnosed with Alzheimer's six years ago at age 55. His wife Sarah had to retire 18 months ago to care for Paul full-time.

Paul Hornback was a senior engineer and analyst for the U.S. Army when he was diagnosed with Alzheimer’s six years ago at age 55. His wife Sarah had to retire 18 months ago to care for Paul full-time. Courtesy of the Hornbeck family hide caption

toggle caption Courtesy of the Hornbeck family

First, Alzheimer’s takes a person’s memory. Then it takes their family’s money.

That’s the central finding of a report published Wednesday by the Alzheimer’s Association on the financial burden friends and families bear when they care for someone with dementia.

“What we found was really startling,” says Beth Kallmyer, vice president of constituent services for the organization. “The cost of paying for care was putting people in a situation where they had to make really difficult choices around basic necessities — things like food, medical care, transportation.”

The report, based on a survey of more than 3,500 Americans contributing to the care of someone with dementia, also found that:

  • Friends and family spent, on average, more than $5,000 a year of their own money on the expenses of their loved one with dementia, ranging from food to adult diapers.
  • More than one-third of these contributors to care who had jobs had to reduce their hours or quit.
  • To make ends meet, about 13 percent had to raise money by selling personal belongings, such as a car.
  • Nearly half of the care contributors surveyed had to dip into their savings or retirement funds.

The Alzheimer’s Association decided to conduct the survey, Kallmyer says, after hearing lots of stories of financial hardship from friends and family members of people with Alzheimer’s. One of those stories came from Paul and Sarah Hornback, who live in central Kentucky.

Paul Hornback was a senior engineer and analyst for the U.S. Army when was diagnosed with Alzheimer’s six years ago. He was just 55.

“I was kind of at the height of my career and then this dreadful diagnosis came and it just wiped out every plan I had for my career,” he says.

Hornback and his wife, Sarah, had to re-imagine their future. Then they began to consider the financial implications.

The Hornbacks had borrowed a lot of money to put three children through college. Now Paul was being forced to retire early and they wouldn’t have his salary to pay off the debt.

“We had to sell basically everything but my wife’s car and an old truck that I kept to drive around here on the farm,” he says.

Paul Hornback lost his engineer's salary when diagnosed with Alzheimer's at age 55. He still tends chores on his farm, but worries about how his wife and kids will pay off the medical debt as his health deteriorates.

Paul Hornback lost his engineer’s salary when diagnosed with Alzheimer’s at age 55. He still tends chores on his farm, but worries about how his wife and kids will pay off the medical debt as his health deteriorates. Courtesy of the Hornback family hide caption

toggle caption Courtesy of the Hornback family

At first, Sarah Hornback kept working as a school administrator. But about 18 months ago, she also had to retire early — to care for her husband.

“It got to the point where it just wasn’t safe for him to stay alone just because of memory and decision making,” she says. “He might leave the stove on or he might decide that there was a tree branch bothering him and he should get out the chain saw.”

The Hornbacks are getting by on their early retirement income. But Sarah Hornback says the real financial problems will start when she can no longer care for her husband on her own.

“When he has to go into full-time care, I’m going to be at the poverty level, basically,” she says.

The financial burden is greatest for people like the Hornbacks, who have to pay more while working less, Kallmyer says.

“It’s really a double whammy,” she says. “People are sometimes not able to work as much or not able to work at all in order to provide care, and then they’re paying money out of pocket on top of that.”

The survey also found that about two-thirds of Americans believe Medicare will help cover nursing home costs, or aren’t sure whether it will. It won’t.

“What that tells us is that families are ultimately unprepared for that really, really significant cost of long-term care,” Kallmyer says.

Clinics that specialize in Alzheimer’s often try to help family members navigate the financial aspects of care.

“It’s a challenge for almost every family that we see,” says Dr. Pierre Tariot, a geriatric psychiatrist and director of the Banner Alzheimer’s Institute in Phoenix. “We do see folks who are lucky and have considerable resources. But even for those families it’s a major financial obligation.”

And it’s not realistic to expect every family to absorb the cost, Tariot says.

“Ultimately,” he says, “society will need to think of other ways of funding care for our elders as they become vulnerable.”

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Supreme Court Orders More Briefs On Birth Control, Hoping To Prevent Tie

Supporters of religious organizations that want to ban contraceptives from their health insurance policies on religious grounds rallied outside the Supreme Court last week.

Supporters of religious organizations that want to ban contraceptives from their health insurance policies on religious grounds rallied outside the Supreme Court last week. Saul Loeb/AFP/Getty Images hide caption

toggle caption Saul Loeb/AFP/Getty Images

The Supreme Court has ordered more legal briefs in the birth control case it heard last week, indicating that the justices are struggling to avoid another 4-4 tie. The case tests the religious liberty claims against the Obamacare mandate for birth control in all health insurance plans.

Some faith-based nonprofits — like hospitals, universities and service organizations — object to signing an opt-out form on the grounds that that action triggers the insurer’s providing birth control coverage separately. At the oral argument last week, several of the conservative justices said the requirement “hijacked” the religious employers’ insurance plans, and a 4-4 tie seemed likely.

In an apparent attempt to prevent a deadlock, the court on Tuesday afternoon asked the government and the religious objectors to address a specific question: whether birth control coverage for employees could be obtained without involving faith-based employers at all; and the court offered a specific suggestion for doing so.

In an unusually detailed order, the court asked whether it would be possible to have objecting nonprofits notify their insurers that they do not want to have their plan cover contraception that they are opposed to, and upon receiving this notification, the insurer would separately notify employees that the insurance company will provide the coverage on its own.

The additional briefs are to be filed by April 20. The government undoubtedly will have to consult with insurance companies to see what health plans can do without adding significant administrative costs. And one of the issues bound to concern the health insurers is where the requirement for separate coverage will end. For instance, what about religious nonprofits that object to blood transfusions, or vaccines, or numerous other medical procedures?

Tuesday’s order for more briefs likely stems from the concerns of Justice Anthony Kennedy, who was among those who called the Obamacare opt-out a “hijacking ” of the religious objectors’ plans at the oral argument last week. He seemed at the time to be grasping for an alternative; but if he is ultimately persuaded there is not a good one, he would likely join the court’s four liberals and make a five-vote majority for upholding the current opt-out provision.

If, on the other hand, he is persuaded there is a good alternative, the liberal justices could either join him or there would be a 4-4 tie. The result of a tie would be that in most of the country, where the opt-out provision has been upheld by the lower courts, the opt-out provision would be the law; but in the states governed by the 8th Circuit Court of Appeals, which struck down the provision, the opt-out measure would be voided. The states in the 8th Circuit are Arkansas, Iowa, Minnesota, Missouri, Nebraska, North Dakota and South Dakota.

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Physician Group Calls On Government To Rein In Drug Prices

“You won’t believe the price of this one!” Gary Waters/Getty Images/Ikon Images hide caption

toggle caption Gary Waters/Getty Images/Ikon Images

It’s not just patients who are getting tired of ever rising drug prices. Doctors are joining the chorus of frustration.

The latest voice? The American College of Physicians, whose membership includes 143,000 internal medicine doctors. It published a position paper Monday calling for the government and industry to take steps to rein in spiraling costs.

“This is consistent with our mission to put the patient first,” Dr. Wayne Riley, ACP president, tell Shots. We’ve heard from our patients, and our patients are frustrated with dealing with this.”

The article, being published Tuesday in Annals of Internal Medicine, says that the U.S. is the only country in the 34-member Organization for Economic Cooperation and Development, which includes most advanced economies, that doesn’t have any government regulation of drug prices.

The ACP paper offered seven recommendations that would change that, and that the physician group says will help control U.S. drug prices. The recommendations include allowing Medicare to negotiate prices with drugmakers and re-importing drugs from countries like Canada, where they’re often sold at a lower cost.

The ACP also wants drugmakers to disclose the actual research and production costs of developing and manufacturing each drug, and to disclose the prices paid for drugs — including discounts and rebates — that take advantage of basic research funded by the government, such as the National Institutes of Health and the Department of Veterans Affairs.

“We particularly feel strongly about those drugs that came to market and made it through the R&D process with support of the NIH grants or VA grants, [that they] should be particularly compliant with more transparency,” Riley says.

People in the pharmaceutical industry dispute that more information about prices will help. “Making it more transparent will make it more clear, but it will have a negative effect on competition,” says Ed Schoonveld, head of the market access and pricing division of ZS Associates, which consults with pharmaceutical companies on pricing.

He says it’s important for doctors to join the discussion on pricing because insurers are moving to restrict access to some drugs to save money, and that may not be best for patients. However, the solutions the ACP is advocating, such as re-importation, may not make a difference, he says.

The Food and Drug Administration has consistently opposed drug importation on safety grounds. In response to a rise in online pharmacy sales to Americans, drugmakers restricted supplies of medicines going to drug distributors in Canada.

About 60 percent of U.S. adults take prescription medications, according to a study from Harvard’s T.H. Chan School of Public Health. While retail prices for brand-name drugs have soared in recent years, the actual prices paid by health plans remain a mystery because they are determined through private negotiations that involve discounts and rebates.

Still, a study from the Kaiser Family Foundation shows that patient copays are rising faster than incomes.

The American College of Physicians’ Riley says the group plans to bring its messages about drug prices to Washington in May, when its members will call on legislators in Congress to press for action.

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