FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research

KFF Health News, April 12, 2018

The probe is looking at anyone outside the company or university who might have been complicit.

This article first appeared April 12, 2018 on Kaiser Health News.

By Marisa Taylor

The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned.

SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

The FDA rarely prosecutes research violations, usually choosing to administratively sanction or ban researchers or companies from future clinical trials, legal experts said. Even so, the agency is empowered to pursue as a crime the unauthorized development of vaccines and drugs — and sometimes goes after such cases to send a message.

In this case, human-subject violations would be deemed especially serious given Halford was not a medical doctor and had injected people with his experimental vaccine without any routine oversight, experts said.

“Since the research appears to be an effort to totally evade FDA oversight and is egregious, it makes sense the FDA would investigate it as a criminal matter,” said Patricia Zettler, a former FDA lawyer who was told of the criminal investigation by KHN. “There is a deterrent effect for others who might consider this a very brazen way to get out of human subject and FDA requirements.”

The FDA declined to comment. Rational Vaccines did not respond to requests for comment. An SIU spokeswoman said, without elaboration, “The government is investigating and we are cooperating.”

Any resulting criminal prosecution from the investigation could have political ramifications.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and the company received millions of dollars in private investment from investors after the Caribbean trial, including from billionaire Peter Thiel.

Thiel, who for months has refused to respond to questions from KHN, contributed to President Donald Trump’s campaign and is a high-profile critic of the FDA. Thiel is part of a larger libertarian movement to roll back FDA regulations to speed up medical innovation.

The sources familiar with the inquiry said the FDA’s Office of Criminal Investigations, which has dozens of offices across the country, began to aggressively pursue the case weeks ago.

The investigators have interviewed witnesses across the country, asking them to identify Halford’s associates, and have described his actions as possible violations of human-subject guidelines and of FDA regulations, the sources told KHN.

The investigators also have expressed interest in whether Halford’s former associates at the university or other researchers and medical professionals outside the university might have helped or known about his conduct, the sources said. They also have raised questions about the company’s knowledge of the violations.

Rational Vaccines helped oversee the Caribbean trial, but the 2013 hotel injections took place before the company was formed.

Under a Supreme Court ruling, a corporate official may be prosecuted for a criminal misdemeanor offense under the Federal Food, Drug and Cosmetic Act even without proof that the official acted with intent or actual knowledge of the offense.

Initially, university officials and Rational Vaccines publicly defended Halford’s research. Rational Vaccines has said it considered the 2016 trial a success — though it is unclear what data it used to support that claim.

After KHN’s investigation revealed that Halford injected people in the United States, not just in the Caribbean, Rational Vaccines took down its website, although it had vowed to continue research.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently and overseas.

After Kaiser Health News raised questions about Halford’s practices, the Department of Health and Human Services asked the university to determine whether his activities violated the institution’s pledge to HHS to follow human-subject safety protocols for all research. SIU’s medical school receives about $ 9 million a year in federal research dollars.

SIU has since acknowledged that Halford’s conduct violated university rules and U.S. laws. University officials have denied knowing about his misconduct, an assertion that FDA investigators are still probing, the sources said.

Halford’s actions already raised unusual legal questions because the FDA would not ordinarily have jurisdiction over clinical trials when they occur overseas and the researchers have not sought FDA approval.

It’s also unclear where Halford manufactured the vaccine.

If it was manufactured in the United States, the FDA likely has jurisdiction, said Zettler, a law professor at Georgia State University.

The OCI often goes after such cases of contaminated food, counterfeit or off-label pharmaceuticals. The office was created in the wake of a 1988 scandal in which pharmaceutical executives bribed FDA officials in exchange for speeding up generic drug approvals.

While rare, the OCI occasionally pursues research abuses as a crime. A GlaxoSmithKline researcher, for instance, pleaded guilty in 2010 to charges related to her fabrication of data in a study of children taking the antidepressant Paxil. GlaxoSmithKline later agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability in the case.

What We Know And Don't Know About Memory Loss After Surgery

KFF Health News, April 12, 2018

Unlike delirium, postoperative cognitive dysfunction can involve subtle, difficult-to-recognize symptoms that develop days to weeks after surgery.

This article first appeared April 12, 2018 on Kaiser Health News.

By Judith Graham

Two years ago, Dr. Daniel Cole’s 85-year-old father had heart bypass surgery. He hasn’t been quite the same since.

“He forgets things and will ask you the same thing several times,” said Cole, a professor of clinical anesthesiology at UCLA and a past president of the American Society of Anesthesiologists.

“He never got back to his cognitive baseline,” Cole continued, noting that his father was sharp as a tack before the operation. “He’s more like 80 percent.”

The old man likely has postoperative cognitive dysfunction (POCD) — a little-known condition that affects a substantial number of older adults after surgery, Cole said.

Some patients with POCD experience memory problems; others have difficulty multitasking, learning new things, following multistep procedures or setting priorities.

“There is no single presentation for POCD. Different patients are affected in different ways,” said Dr. Miles Berger, a POCD specialist and assistant professor of anesthesiology at Duke University School of Medicine.

Unlike delirium — an acute, sudden-onset disorder that affects consciousness and attention — POCD can involve subtle, difficult-to-recognize symptoms that develop days to weeks after surgery.

Most of the time, POCD is transient and patients get better in several months. But sometimes — how often hasn’t been determined — this condition lasts up to a year or longer.

Dr. Roderic Eckenhoff, vice chair for research and a professor of anesthesiology at the Perelman School of Medicine at the University of Pennsylvania, told of an email he received recently from a 69-year-old man who had read about his research.

“This guy — a very articulate man — said he was the intellectual equal of his wife before a surgery 10 years ago, a significant operation involving general anesthesia. Since then, he’s had difficulty with cognitively demanding tasks at work, such as detailed question-and-answer sessions with his colleagues,” Eckenhoff said. “He noticed these changes immediately after the surgery and claims he did not get better.”

There are many unanswered questions about POCD. How should it best be measured? Is it truly a stand-alone condition or part of a continuum of brain disorders after surgery? Can it be prevented or treated? Can it be distinguished in the long term from the deterioration in cognitive function that can accompany illness and advanced aging?

Some clarity should come in June, when a major paper outlining standard definitions for POCD is set to publish simultaneously in six scientific journals and scientists will discuss the latest developments at a two-day POCD summit, according to Eckenhoff.

Here’s what scientists currently know about POCD:

Background. POCD first began to be studied systematically about 20 years ago. But reports of patients who appeared cognitively compromised after surgery date back about 100 years, Eckenhoff said.

An influential 1955 report in The Lancet noted common complaints by family or friends after someone dear to them had surgery: “He’s become so forgetful. … She’s lost all interest in the family. … He can’t concentrate on anything. … He’s just not the same person since.”

How to recognize the condition. There is no short, simple test for POCD. Typically, a series of neuropsychological tests are administered before and after surgery — a time-consuming process. Often, tests are given one week and again three months after surgery. But the tests used and time frames differ in various studies. Studies also define POCD differently, using varying criteria to assess the kind and extent of cognitive impairment that patients experience.

How common is it? The first international study of older adults with POCD (those age 60 and older) in 1999 suggested that 25.8 percent of patients had this condition one week after a major non-cardiac surgery, such as a hip replacement, while 9.9 percent had it three months after surgery.

Two years later, a study by researchers at Duke University Medical Center, published in the New England Journal of Medicine, found that 53 percent of adults who had heart bypass surgery showed significant evidence of cognitive decline when they were discharged from the hospital; 36 percent were affected at six weeks; 24 percent, at six months; and 42 percent, five years after their operations.

Another Duke study of older adults who had knee and hip replacements found that 59 percent had cognitive dysfunction immediately after surgery; 34 percent, at three months; and 42 percent, at two years.

Other studies have produced different estimates. A current research project examining adults 55 and older who have major non-cardiac surgeries is finding that “upwards of 30 percent of patients are testing significantly worse than their baseline 3 months later,” according to its lead researcher, Dr. Stacie Deiner, vice chair for research and associate professor of anesthesiology, geriatrics and palliative care, and neurosurgery at the Icahn School of Medicine at Mount Sinai in New York City.

Vulnerabilities. The risk of experiencing POCD after surgery is enhanced in those who are older, have low levels of education or have cognitive concerns that predate surgery. Adults age 60 and older are twice as likely to develop POCD as are younger adults — a development that increases the risk of dying or having a poor quality of life after surgery.

“People who are older, with some unrecognized brain pathology, or people who have some trajectory of cognitive decline at baseline, those are the patients who you’re going to see some change in one, two or three years out,” said Charles Hugh Brown IV, assistant professor of anesthesiology and critical care medicine at Johns Hopkins Medicine.

Researchers have examined whether the type of anesthetic used during surgery or the depth of anesthesia — the degree to which a patient is put under — affects the risk of developing POCD. So far, results have been inconclusive. Also under investigation are techniques to optimize blood flow to the brain during surgery.

Mechanisms at work. What’s responsible for POCD? The drugs administered during anesthesia or the surgery itself? Currently, the evidence implicates the stress of surgery rather than the anesthesia.

“Most surgery causes peripheral inflammation,” Eckenhoff explained. “In young people, the brain remains largely isolated from that inflammation, but with older people, our blood-brain barrier becomes kind of leaky. That contributes to neuroinflammation, which activates a whole cascade of events in the brain that can accelerate the ongoing aging process.”

At Mount Sinai, Deiner has been administering two-hour-long general anesthesia to healthy seniors and evaluating its impact, in the absence of surgery. Older adults are getting cognitive tests and brain scans before and after. While findings haven’t been published, early results show “very good and rapid cognitive recovery in older adults after anesthesia,” Deiner said. The implication is that “the surgery or the medical conditions surrounding surgery” are responsible for subsequent cognitive dysfunction, she noted.

Advice. Currently, most patients are not told of the post-surgical risk of POCD during the process of informed consent. That should change, several experts advise.

“Beyond question, patients should be informed that the ‘safety step’ of not undergoing surgery is theirs to choose,” wrote Dr. Kirk Hogan, professor of anesthesiology at the University of Wisconsin-Madison School of Medicine and Public Health, in an article published earlier this year. “Each patient must determine if the proposed benefits of a procedure outweigh the foreseeable and material risks of cognitive decline after surgery.”

“Surgery is a good thing — it improves quality of life — and most older patients do really well,” said Brown of Hopkins. “Our trick is to understand who we really need to identify as high-risk and what we can do about modifiable factors.

“If you’re older and suspect you have cognitive issues, it’s important to let your family physician as well as your surgeon and anesthesiologist know that you’re concerned about this and you don’t want to get worse. That should open up a conversation about the goals of surgery, alternatives to surgery and what can be done to optimize your condition before surgery, if that’s what you want to pursue.”

“We want people to know this does happen but not be too concerned because, typically, it does go away,” said Eckenhoff. “That said, don’t try to make cognitively demanding decisions in the first 30 days after an operation. And make sure your caregivers are prepared to help with anything from paying bills and balancing the checkbook to ensuring that you’re caring for yourself adequately and communicating well with your doctor.”

How A Drugmaker Turned The Abortion Pill Into A Rare-Disease Profit Machine

KFF Health News, April 10, 2018

The story highlights how America's drug development system can turn an old drug into a new one that treats relatively few - but often very desperate - patients.

This article first appeared April 10, 2018 on Kaiser Health News.

By Sarah Jane Tribble

Even though the $550 yellow pills sold as Korlym have a controversial origin as the abortion pill, Leslie Edwin says they “gave me life.”

The 40-year-old Georgia resident lives with Cushing’s syndrome, a potentially deadly condition that causes high levels of the hormone cortisol to wreak havoc on a body. When first diagnosed, she said, she gained about 100 pounds, her blood sugars were “out of control,” and she suffered acne, the inability to sleep and constant anxiety.

“I wouldn’t leave the house,” Edwin said of her first bout with the condition. “I quit my job after a certain point. I just couldn’t keep being in front of people.”

That’s when Edwin endured surgeries, including one to remove her pituitary gland. She went into remission, but then, in 2016, her weight shot up 30 pounds and the anxious feelings returned. Her doctors prescribed Korlym.

The drug’s active ingredient is mifepristone, once called RU-486 and better known as the abortion pill because it causes a miscarriage when taken early in a pregnancy. Nearly two decades ago, Danco Laboratories won approval to market Mifeprex in the U.S. as the abortion drug, with tight restrictions on use. Corcept Therapeutics, a Silicon Valley-based drug company, began marketing Korlym six years ago as a specialty drug for about 10,000 rare-disease patients such as Edwin.

The difference in price between Korlym and Mifeprex is striking, even though the ingredients are the same: One 200-milligram pill to prompt an abortion costs about $80. In contrast, a 300-milligram pill prescribed for Cushing’s runs about $550 before discounts. Patients wanting an abortion take only one pill. People with Cushing’s often take up to three pills a day for months or years.

Dr. Joseph Belanoff, chief executive of the drug’s maker, Corcept, said Korlym’s average cost per patient is $180,000 annually and concedes that “we have an expensive drug. There’s no getting around that.”

The story of Korlym highlights how America’s drug development system can turn an old drug into a new one that treats relatively
few — but often very desperate — patients.

When the Food and Drug Administration approved Korlym in 2012, it was designated as an orphan drug, giving Corcept seven years of market exclusivity as well as other economic incentives. Congress approved orphan drug incentives to encourage the development of medicines for rare diseases that affect fewer than 200,000 patients. Since the drug’s approval, Korlym’s price has risen about 150 percent, and last year the company’s revenue nearly doubled to $159.2 million. (Korlym is the company’s only product and treats about 1,000 patients in the U.S.)

“You can hike that drug [price] 50 percent or 80 percent, and if there is backlash you can walk it back,” said Dr. Joshua Liao, an associate medical director at University of Washington Medicine.

Corcept has steadily increased the price with little backlash.

Belanoff said the profits from Korlym pay for the company’s past spending on the drug’s research and development as well as its effort to create new drugs. The company last month reported an encouraging Phase 2 trial update on Korlym’s successor, relacorilant, a drug that could treat Cushing’s without the side effects for some women of endometrial thickening and possible vaginal bleeding.

The company’s pipeline is also full of potential oncology drugs that hold the promise of using molecules to influence the cortisol receptors, with wide-ranging effects in the body. Korlym in combination with another drug is being tested for the treatment of metastatic triple-negative breast cancer, which tends to be more aggressive than other types of breast cancer. And relacorilant is in the very early stages of testing to treat castration-resistant prostate cancer.

While many of the second-generation drugs are not related to Korlym structurally, Korlym did “provide the funding. … If there had not been orphan-drug pricing and the [Orphan Drug] Act, you would have to look for a different way to develop those drugs,” Belanoff said.

Korlym came to market in 2012 with an average wholesale price of $223.20 per pill before discounts, according to the health care technology firm Connecture. Corcept boosted the price $20 to $50 each year. By December 2017, each pill had an average wholesale price of $549.60 before any discounts or rebates were negotiated for patients.

Alan Leong, senior research analyst and owner of BioWatch, who follows Corcept, said he thought the company might fail at one point but noted that Belanoff “played the odds” with Korlym and won.

So far, incrementally increasing Korlym’s price while adding patients has paid off. Corcept’s stock soared 27.4 percent in January before Teva Pharmaceutical Industries announced it had filed an application for a generic version on the drug. Teva declined to comment for this story.

Belanoff said he would like to know where Teva obtained enough doses of Korlym to successfully test a generic: “We have a single pharmacy and a single manufacturer and the medicine has to be [FedEx’ed] to the patient.”

Talking to analysts last month, Corcept Chief Financial Officer Charlie Robb said the impact of Teva’s generic filing for the next few years is “nothing but litigation, which we can comfortably afford.”

Corcept’s executives expect revenues to keep climbing, reaching $275 million to $300 million in 2018 — an expectation that has not changed despite Teva’s announcement.

A ‘Pioneering Substance’

Cushing’s syndrome happens when the body produces too much of the powerful hormone cortisol, which normally helps keep the cardiovascular system functioning well and allows the body to turn proteins, carbohydrates and fats into energy. But too much cortisol can be destructive. It can cause cognitive difficulties, depression, fatigue, high blood pressure, bone loss and, in some cases, Type 2 diabetes. Those affected by the syndrome can develop a fatty hump between their shoulders and a rounded face. Without treatment, patients can die of a variety of complications, including sepsis after the hormone compromises the immune system.

Mifepristone, the active ingredient in Korlym, helps Cushing’s patients by blocking the body’s ability to process cortisol. It induces an abortion by blocking the body’s receptor for progesterone, which causes the uterine wall to break down.

When the FDA approved Korlym for a specific set of Cushing’s patients, the agency required a “TERMINATION OF PREGNANCY” warning box at the top of the label.

Dr. Constantine Stratakis, a senior investigator and scientific director at the National Institute of Child Health and Human Development who specializes in treating people with Cushing’s syndrome, calls mifepristone a “pioneering substance” because it “has a lot of crossover” to other receptors in the body.

That means the drug has a lot of potential uses. Belanoff and Dr. Alan Schatzberg, a Stanford University psychiatrist and scientist, co-founded Corcept in 1998 to explore whether mifepristone could help treat major depression. In 2002, Schatzberg said the drug “may be the equivalent of shock treatments in a pill.”

But clinical trials didn’t back up the claim. Schatzberg rotated off the board and left the company in 2007, saying the company “went in a different direction.” A congressional investigation also questioned whether Schatzberg had conflicts of interest as the government’s principal investigator overseeing clinical trials and a co-founder of Corcept, which had awarded him stock options.

In response to the congressional investigation, Stanford said Schatzberg was fully compliant with its internal conflict-of-interest policy.

Leong of BioWatch recalls the transition to Cushing’s research as a difficult time for Corcept. But after the “psychiatric depression program shut down, [Belanoff] stuck to it,” Leong said.

Social Contract

Corcept’s “Hail Mary” moment came in 2007. The company filed an application to see whether mifepristone might work for Cushing’s patients. (Cushing’s affects about 20,000 people in the U.S., but Corcept executives say the condition often goes undiagnosed.)

Developing the drug cost about $300 million, Belanoff estimates, and involved long-term toxicology tests to ensure that patients could safely take higher doses for months or years. As an orphan drug, a portion of Korlym’s research and development costs could be written off. For example, Corcept reported in 2013 that it had $19.7 million in federal tax credits.

And while Korlym’s annual costs pale against other specialty drugs, which run as high as $750,000 a year, the climbing price tag and increasing number of patients do affect the health care system.

“It’s like an unseen cost and then down the road this is a huge cost burden,” said the University of Washington’s Liao.

Most patients are covered by private insurance, Belanoff said, but Medicare and Medicaid are paying for the drug as well. According to Medicare Part D data, 52 Korlym patients cost Medicare $2.6 million in 2013. Two years later in 2015, 115 beneficiaries filed claims of $11.4 million.

In Georgia, Leslie Edwin is on private insurance and describes herself as being in “a really high tax bracket” yet she never paid more than $25 a month through Corcept’s patient assistance program called SPARK (the Support Program for Access and Reimbursement for Korlym).

“Across the board, it would be very difficult to find any patient that pays the full price,” said Edwin, who volunteers as president of the nonprofit patient advocacy group Cushing’s Support and Research Foundation. The small organization, which reported $50,000 in contributions and grants in 2015, notes on its website that Corcept as well as Novartis Oncology provide financial support to the organization. Edwin is not paid, and the group’s federal tax filing details that the majority of its expenses go to distributing a quarterly newsletter, contacting members and patients “to promote mission,” and providing referrals to doctors.

Belanoff said he believes Corcept has a “social contract” to take care of patients and pledged that any patient who is prescribed Korlym will get it regardless of insurance coverage or costs.

“We were starting with a notorious drug, and the growth has been steady from a very low base over time,” Belanoff said, emphasizing that the “single most important thing” is that the drug works very well.

Dr. Sherwin D’Souza at St. Luke’s Boise Medical Center in Idaho prescribed Korlym for the first time last year to Vonda Huddleston, knowing the company would provide financial assistance until Huddleston could get insurance to pay for surgery.

Huddleston, though, recalled being concerned about the price and what it would cost her out-of-pocket. The company provided her first two months’ worth for free and asked her to call back when she was enrolled for insurance.

Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?

KFF Health News, April 6, 2018

KHN launches 'Pre$cription for Power,' a groundbreaking database to expose Big Pharma's ties to patient groups.

This article first appeared April 06, 2018 on Kaiser Health News.

By Emily Kopp and Sydney Lupkin and Elizabeth Lucas

KHN staffers Vickie Connor, Julie Appleby, Melissa Bailey, Rachel Bluth, Terry Byrne, Doug Carroll and Brianna Labuskes also contributed.

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies over 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

To learn more about how Kaiser Health News built the Pre$cription for Power database, read our methodology.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania who co-authored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

"There aren’t a lot of large pockets of funding outside of the pharmaceutical money. We take it where we can find it."

Lorren Sandt, Caring Ambassadors Program

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent — in varying degrees — about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups — with annual revenues as large as $3.6 million — relied on the pharmaceutical companies for at least 20 percent of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What Drives The Money Flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act — a law that required payments to physicians from makers of drugs and devices to be registered on a public website — but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

"It’s clear that more transparency in this space is vitally important."

Sen. Claire McCaskill (D-Mo.)

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015 the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as The National Women’s Health Network, based in Washington, D.C., make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.”

Charity As Marketing

Patients newly diagnosed with a disease often turn to patient advocacy groups for advice, but the money flow to such groups may distort patients’ knowledge and public debate over treatment options, said Dr. Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center program that is critical of some pharmaceutical marketing practices.

“[The money flow limits] their advocacy agenda to competing branded products when the best therapy might be generics, over-the-counter drugs or diet and exercise,” she said.

AbbVie — whose specialty drug Humira made up 65 percent of the company’s net revenue in 2017 and is used to treat patients with autoimmune diseases, including Crohn’s disease and certain kinds of arthritis — gave $2.7 million to the Crohn’s & Colitis Foundation and $1.6 million to the Arthritis Foundation, according to the company’s public disclosures included in the database. The list price for a month’s supply of Humira, a biologic drug, is $4,872, according to Express Scripts, a pharmacy benefits manager.

Even though Humira will face competition from near-copycat drugs called biosimilars, it is expected to remain the highest-grossing drug in the United States through 2022, according to drug industry analysts at EvaluatePharma.

The Arthritis and Crohn’s foundations have been largely silent on the cost of Humira and vocal on safety concerns about biosimilars. The Arthritis Foundation has championed state laws that could add extra steps for consumers to receive biosimilars at the pharmacy counter, potentially keeping more patients on the brand-name drug. Experts say those laws could help protect Humira’s market share from generic competitors.

A coalition of patient groups, Patients for Biologics Safety & Access, opposes the automatic substitution of a cheaper biosimilar when doctors prescribe a biologic. In 2015, members of that coalition, including the Crohn’s & Colitis Foundation, the Arthritis Foundation and the Lupus Foundation of America, accepted about $9.1 million from pharmaceutical companies in the database, according to public disclosures. They include AbbVie and Johnson & Johnson, makers of blockbuster biologics.

The Arthritis Foundation did not deny receiving the money but said the foundation represents patients, not sponsors. It is “optimistic” about biosimilars’ ability to help patients and save them money, said Anna Hyde, vice president of advocacy and access. “The Foundation supports the Food and Drug Administration’s scientific standards in evaluating the safety and efficacy of biosimilars, and we support policies that encourage innovation and foster a competitive marketplace.”

To learn more about how Kaiser Health News built the Pre$cription for Power database, read our methodology.

The Crohn’s & Colitis Foundation maintains “more than an arm’s-length distance” from its donors in the pharmaceutical industry, who have no say over the foundation’s strategic objectives, said president and CEO Michael Osso.

He added that the foundation’s position on biosimilars is “evolving.”

Lupus Foundation CEO Sandra Raymond said she could not explain how her group, also based in Washington, was involved in the coalition. She confirmed the Lupus Foundation received $444,000 from Pfizer in 2015 but said the money was not linked to any relationship with Patients for Biologics Safety & Access.

“I never went to a meeting,” Raymond said. “A former employee signed us up for a whole host of coalitions. I think we put our name on something or someone did.”

She said the Lupus Foundation was no longer a member of the coalition. Days after Kaiser Health News reached out to the coalition, its website was updated, excluding the Lupus Foundation.

For its part, AbbVie — which overall donated $24.7 million to patient groups in 2015, according to the new database — stipulates that its grants to nonprofits are “non-promotional” and provide no direct benefit to its business, according to a company statement. The company gives to patient groups because they serve as an “important, unbiased and independent resource for patients and caregivers.”

Insulin And Influence

The American Diabetes Association said in an email to KHN that it received $18.3 million in pharmaceutical funding in 2017, accounting for 12.3 percent of its revenue; that was down from $26.7 million in 2015. The money flowed in as insulin makers continued to hike prices in those years — up to four times per product — leading to hardships for patients.

The only “Big Three” insulin maker in the database, Eli Lilly, gave $2.9 million to the American Diabetes Association in 2015, according to disclosures from the company and its foundation. Sanofi and Novo Nordisk are the other two major insulin makers, but neither was in the S&P 500 and therefore not included in the database. Over the past 20 years, Eli Lilly has repeatedly raised prices on its bestselling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests — by people demanding to know the cost of manufacturing a vial of insulin — at its Indianapolis headquarters last fall.

The ADA launched a campaign decrying “skyrocketing” insulin in late 2016 but did not call out any drugmaker in its literature. When legislators in Nevada passed a bill last year requiring insulin makers to disclose their profits to the public, the ADA did not take a public stance.

The American Diabetes Association said it doesn’t confront individual companies because it is seeking action from “all entities in the supply chain” — manufacturers, wholesalers, pharmacy benefit managers and insurers.

“As a public health organization, the ADA’s commitment and focus is on the needs of the more than 30 million people with diabetes,” said Dr. William Cefalu, its chief scientific and medical officer. “The ADA requires support from a diverse set of partners to achieve this objective.”

Eli Lilly said it contributes money to the American Diabetes Association because the two share a “common goal” of helping diabetes patients.

“We provide funding for a wide variety of educational programs and opportunities at ADA, and they design and implement those programs in ways that are aligned with their goals,” Eli Lilly said in a statement. “We’re proud to support the ADA on important work that helps millions of people living with diabetes.”

Most patient groups say that funders have little or no influence in shaping their programs and policies, but their agreements are private.

They Weren’t Always Backed By Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

"Sick consumers make for good press."

Dr. Adriane Fugh-Berman, PharmedOut

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner — pharma or otherwise — decides our mission priorities,” including a scientific advisory board — free of sponsor influence — that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington — plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said.

Marching Into The Future

Patient groups have been successful at campaigning for drug approvals, at times sparking controversy.

To learn more about how Kaiser Health News built the Pre$cription for Power database, read our methodology.

When scientists within the FDA advised against the approval of Exondys 51, a drug to treat Duchenne muscular dystrophy, parents of children with the rare genetic disorder and patients rallied to lobby for it in Washington. They were seen as pivotal to the FDA’s 2016 decision to grant approval for the drug, made by Sarepta Therapeutics. The decision was controversial in part because the FDA noted that clinical benefits of the drug — aimed at a subset of people with Duchenne muscular dystrophy — were not yet established.

Sarepta Therapeutics, which is not featured in the database, has taken measures to support its patient base. In March, it announced an annual scholarship program — 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta Therapeutics is also among the funders of Parent Project Muscular Dystrophy, a patient advocacy group at the forefront of the push for Exondys 51’s approval.

The Pre$cription for Power database will grow to include new disclosures. Not all drugmakers are willing to disclose their company giving. Eleven of the 20 companies examined — Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals and Vertex Pharmaceuticals — declined to disclose their company giving or did not respond to repeated calls.

Paul Thacker, a former investigator for Sen. Chuck Grassley (R-Iowa) who helped draft the Physician Payments Sunshine Act in 2010, said there is reason to question the flow of money to patient advocacy groups. The pharmaceutical industry has fostered relationships in every link of the drug supply chain, including payments to researchers, doctors and professional societies.

“There’s so much money out there, and they’ve created all of these allies, so nobody is clamoring for change,” Thacker said.

Since the Physician Payments Sunshine Act began requiring the industry to report its payments to physicians, the industry is more reluctant to co-opt them, so “pharma has to find other megaphones,” PharmedOut’s Fugh-Berman said.

And in times of public outrage over high drug prices and soaring insurance costs, patients are particularly sympathetic messengers, she said.

“Sick consumers make for good press,” Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

'Nightmare Bacteria' Stalk U.S. Hospitals

KFF Health News, April 4, 2018

Studies show that aggressive hospital action can limit the spread of outbreaks.

This article first appeared April 03, 2018 on Kaiser Health News.

By Liz Szabo

[UPDATED at 3:15 p.m. ET on April 3]

The Centers for Disease Control and Prevention detected more than 220 cases last year of a rare breed of "nightmare bacteria" that are virtually untreatable and capable of spreading genes that make them impervious to most antibiotics, according to a report released Tuesday.

Although the CDC has warned of the danger of antibiotic-resistant bacteria for years, the new report helps illustrate the scope of the problem. Dr. Anne Schuchat, the CDC's principal deputy director, said she was surprised by the extent of the spread.

"As fast as we have run to slow [antibiotic] resistance, some germs have outpaced us," Schuchat said. "We need to do more and we need to do it faster and earlier."

The CDC set up a nationwide lab network in 2016 to help hospitals quickly diagnose these infections and stop them from spreading.

One in 4 germ samples sent to the lab network had special genes that allow them to spread their resistance to other germs, the CDC said. In 1 in 10 cases, people infected with these germs spread the disease to apparently healthy people in the hospital — such as patients, doctors or nurses — who in turn can act as silent carriers of illness, infecting others even if they don't become sick.

Nightmare bacteria — those that are resistant to almost every drug — are particularly deadly in the elderly and people with chronic illnesses. Up to half of the resulting infections prove fatal, Schuchat said.

While those bacteria are terrifying on their own, the "unusual" genes discussed in this report are truly the "worst of the worst," said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. About 2 million Americans are sickened by antibiotic-resistant bacteria each year and 23,000 die, according to the CDC.

"There are certain bacterial genes that are more worrisome than others, that are much harder to treat," Adalja said. "These genes are lurking in American patients and they are spreading in hospitals and health care facilities."

Many researchers have worried about the emergence of a "post-antibiotic era," in which patients succumb to once-treatable infections. Antibiotics don't just save lives when people develop infectious diseases such as pneumonia. They are also the "safety net" for patients undergoing surgery and cancer treatment, Schuchat said.

Dr. Michael Osterholm compared the problem to a "slow-moving tsunami."

"This isn't an acute crisis where a wave just hits you," said Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy. "But we see these rare cases of resistance in remote areas of the world, and within a year or two, it's everywhere."

As alarming as the new numbers are, Schuchat said there is good news to report.

Studies show that aggressive hospital action can limit the spread of outbreaks.

In one case, the CDC network helped diagnose bacteria carrying resistance genes in an Iowa nursing home resident with a urinary tract infection. Public health staff tested 30 other nursing home residents and found five were infected.

Aggressive measures, such as wearing gowns and gloves while caring for infected patients, prevented anyone else from becoming sick, Schuchat said.

Aggressively diagnosing and containing such infections can reduce infections by 76 percent, the CDC said.

Dr. William Schaffner, a professor of preventive medicine and health policy disease at Vanderbilt University School of Medicine, said the CDC's efforts to contain and slow the spread of nightmare bacteria seem to be working.

The CDC lab "network is working at an absolutely high level of effectiveness," Schaffner said. "It's identifying problems with great precision and initiating the appropriate response with the local health department and hospital staff.

"That's the ‘good news spin' bun around a scary hot dog," Schaffner said.

Maintaining these labs is vital, said Dr. Paul Auwaerter, president of the Infectious Diseases Society of America.

Containing antibiotic resistance "is vital to maintaining the strides made in many areas of modern medicine," Auwaerter said.

Osterholm said world leaders need to do far more to prevent antibiotic resistance.

A 2016 report commissioned by the British government and Wellcome Trust called for investing $40 billion over the next decade to fight the problem. About 700,000 people around the world die due to antibiotic resistance each year. Without immediate action, annual deaths could rise to 10 million by 2050, according to the report.

Bacteria naturally evolve to resist drugs used against them. The more the drugs are used, the faster this happens, Osterholm said.

While developing new antibiotics can help, Osterholm compared that approach to "trying to dig yourself out of a hole."

It's far more important that countries around the world use antibiotics more judiciously, Osterholm said. Doctors today often prescribe antibiotics when they're not needed.

In developing nations, patients often buy antibiotics on the street, Osterholm said, noting that antibiotics are also widely used in agriculture.

Vaccines can also help fight antibiotic resistance, he said, by preventing people from ever becoming sick and needing antibiotics.

Medicare Advantage Plans Cleared To Go Beyond Medical Coverage - Even Groceries

KFF Health News, April 4, 2018

Many plans already offer some health benefits not covered by traditional Medicare. But the new rules will expand that significantly.

This article first appeared April 03, 2018 on Kaiser Health News.

By Susan Jaffe

Air conditioners for people with asthma, healthy groceries, rides to medical appointments and home-delivered meals may be among the new benefits added to Medicare Advantage coverage when new federal rules take effect next year.

On Monday, the Centers for Medicare & Medicaid Services (CMS) expanded how it defines the "primarily health-related" benefits that insurers are allowed to include in their Medicare Advantage policies. And insurers would include these extras on top of providing the benefits traditional Medicare offers.

"Medicare Advantage beneficiaries will have more supplemental benefits making it easier for them to lead healthier, more independent lives," said CMS Administrator Seema Verma.

Of the 61 million people enrolled in Medicare last year, 20 million have opted for Medicare Advantage, a privately run alternative to the traditional government program. Advantage plans limit members to a network of providers. Similar restrictions may apply to the new benefits.

Many Medicare Advantage plans already offer some health benefits not covered by traditional Medicare, such as eyeglasses, hearing aids, dental care and gym memberships. But the new rules, which the industry sought, will expand that significantly to items and services that may not be directly considered medical treatment.

CMS said the insurers will be permitted to provide care and devices that prevent or treat illness or injuries, compensate for physical impairments, address the psychological effects of illness or injuries, or reduce emergency medical care.

Although insurers are still in the early stages of designing their 2019 policies, some companies have ideas about what they might include. In addition to transportation to doctors’ offices or better food options, some health insurance experts said additional benefits could include simple modifications in beneficiaries’ homes, such as installing grab bars in the bathroom, or aides to help with daily activities, including dressing, eating and other personal care needs.

"This will allow us to build off the existing benefits that we already have in place that are focused more on prevention of avoidable injuries or exacerbation of existing health conditions," said Alicia Kelley, director of Medicare sales for Capital District Physicians' Health Plan, a nonprofit serving 43,000 members in 24 upstate New York counties.

Even though a physician's order or prescription is not necessary, the new benefits must be "medically appropriate" and recommended by a licensed health care provider, according to the new rules.

Many beneficiaries have been attracted to Medicare Advantage because of its extra benefits and the limit on out-of-pocket expenses. However, CMS also cautioned that new supplemental benefits should not be items provided as an inducement to enroll.

The new rules "set the stage to continue to innovate and provide choice," said Cathryn Donaldson, of America's Health Insurance Plans, a trade group.

"CMS is catching up with the rest of the world in terms of its understanding of how we keep people healthy and well and living longer and independently, and those are all positive steps," said Ceci Connolly, chief executive officer of the Alliance of Community Health Plans, which represents nonprofit health insurance plans. Some offer non-emergency medical transportation, low-cost hearing aids, a mobile dental clinic and a "grocery on wheels," to make shopping more convenient, she said.

UnitedHealthcare, the largest health insurer in the U.S., also welcomes the opportunity to expand benefits, said Matt Burns, a company spokesman. “Medicare benefits should not be one-size-fits-all, and continued rate stability and greater benefit design flexibility enable health plans to provide a more personalized health care experience," he said.

But patient advocates including David Lipschutz. senior policy attorney at the Center for Medicare Advocacy, are concerned about those who may be left behind. "It's great for the people in Medicare Advantage plans, but what about the majority of the people who are in traditional Medicare?” he asked. "As we tip the scales more in favor of Medicare Advantage, it's to the detriment of people in traditional Medicare."

The details of the 2019 Medicare Advantage benefit packages must first be approved by CMS and will be released in the fall, when the annual open enrollment begins. It's very likely that all new benefits will not be available to all beneficiaries since there is "tremendous variation across the country" in what plans offer, said Gretchen Jacobson, associate director of the Kaiser Family Foundation’s Program on Medicare Policy. (Kaiser Health News is an editorially independent program of the foundation.)

Addressing a patient's health and social needs outside the doctor's exam room isn't a new concept. The Institute on Aging, for example, is a California nonprofit that offers health, social, and psychological services for seniors and adults with disabilities. It has helped people in San Francisco and Southern California move from nursing homes to their own homes and provides a variety of services to make their new lives easier, from kitchen supplies to wheelchair ramps.

"By taking a more integrated approach to address people's social and health needs, we have seen up to a 30 percent savings in health care costs compared to the costs of the same individuals before they joined our program," said Dustin Harper, the institute's vice president for strategic partnerships. The agency serves 20,000 Californians a year, including former nursing home residents, who qualify for Medicare or Medicaid, the federal-state health insurance program for low-income people, or both.

In addition to next year's changes in supplemental benefits, CMS also noted that a new federal law allows Medicare Advantage plans to offer benefits that are not primarily health-related for Medicare Advantage members with chronic illnesses. The law and the agency's changes are complementary, CMS officials said. They promised additional guidance in the coming months to help plans differentiate between the two.

Atlanta Struggles To Meet MLK's Legacy On Health Care

KFF Health News, April 4, 2018

A recent study found that 80 percent of the city's black children live in neighborhoods with high concentrations of poverty, which often have poor access to quality medical care.

This article first appeared April 04, 2018 on Kaiser Health News.

By Virginia Anderson

ATLANTA — While public safety commissioner Bull Connor’s police dogs in 1963 attacked civil rights protesters in Birmingham, Ala., leaders in Martin Luther King Jr.’s hometown of Atlanta were burnishing its reputation as “the city too busy to hate.”

Yet 50 years after the civil rights leader was killed, some public health leaders here wonder whether the city is failing to live up to King’s call for justice in health care. They point to substantial disparities, particularly in preventive care.

“We have world-class health care facilities in Atlanta, but the challenge is that we’re still seeing worse outcomes” for African-Americans, said Kathryn Lawler, executive director of the Atlanta Regional Collaborative for Health Improvement. That group includes representatives of more than 100 nonprofit organizations, governments, hospital systems and other health care providers working to improve access and care for minority communities.

“We did certain things here, we went through the civil rights era, and we did things like desegregation, but we just over the years never kept the conversation going,” said Tom Andrews, president of Mercy Care, a health center that serves mainly homeless Atlantans, the vast majority of whom are African American.

Among the problems:

— Atlanta has the widest gap in breast cancer mortality rates between African-American women and white women of any U.S. city, with 44 black patients per 100,000 residents dying compared with 20 per 100,000 white women, according to a study in the journal Cancer Epidemiology in 2016.

— It is the city with the nation’s highest death rate for black men with prostate cancer, with a rate of 49.7 deaths per 100,000 residents. The mortality rate for white men here is 19.3, the National Cancer Institute reports.

— There’s a 12-year or greater difference in life span among neighborhoods in Fulton County, of which Atlanta is the county seat. Those living in the city’s Bankhead or Northwest neighborhoods, which are predominantly black, fare worse when compared to those who live in affluent, mainly white Buckhead, researchers at Virginia Commonwealth University found.

— Large gaps in mortality exist between African-Americans and whites in such diseases as HIV, stroke and diabetes, according to the Georgia Department of Public Health.

African-Americans make up just over half of the city’s residents. But a recent study found that 80 percent of black children here live in neighborhoods with high concentrations of poverty, which often have poor access to quality medical care, while 6 percent of white children do. Several of the neighborhoods with predominately minority communities have poverty rates higher than 40 percent.

"I think we should be further along in Atlanta, but I think we should be further along in all cities in this country,” said Dr. David Satcher, a former U.S. surgeon general and now senior adviser at the Satcher Health Leadership Institute at Morehouse School of Medicine here.

The health gaps between African-Americans and whites in Atlanta or in any U.S. city are not due necessarily to shortcomings in the health care system, according to people who have studied the issue. Rather, they are the result of decades of discrimination.

“It’s a constellation of things,” said Thomas LaVeist, chairman of the department of health policy and management at the George Washington University's school of public health in Washington, D.C. “African-Americans couldn’t own land, wealth couldn’t transfer from one generation to the next. Those were advantages [for whites] that were formed decades ago.”

"The disparities are really national problems,” he added, “and there really is not a city that's spared."

The result has been, the experts said, lower incomes, lower levels of education, higher stress, unsafe neighborhoods, lack of insurance and a host of other social factors that combine, over the years, to create differences in quality of health.

It starts with a lack of preventive care, said Dr. Otis Brawley, chief medical officer of the American Cancer Society and a longtime Atlanta resident. In addition to not having insurance or money for care, many African-Americans lack trust in the health care system and see it as another part of American life that has let them down.

Ricardo Farmer, 57, has not been to a doctor for a checkup in almost 30 years, he said. He is uninsured, and his funds are limited. More than anything, however, Farmer said he does not trust the health care system.

“If I don’t have any symptoms, I feel like I don’t need to go,” said the tile craftsman.

Yet he has a back problem that causes him to miss work occasionally, and he has high blood pressure, which he self-treats by reducing his salt intake and giving up meat, and asthma, which sometimes forces him to the emergency room because he has trouble breathing.

An Abundance Of Health Care, For Some

Atlanta is a major health care hub, home to the federal Centers for Disease Control and Prevention, the American Cancer Society, the Arthritis Foundation, two schools of medicine and several universities that offer degrees in public health. And yet health care is still a scarce commodity in many poor neighborhoods.

“Atlanta spends $11 billion on health care in a given year, but much of that is misspent,” said Lawler. Too many patients end up in emergency rooms, for example, because they do not have a primary care doctor or seek treatment after their illnesses are much more advanced, she added.

In addition, after being diagnosed, getting treatment can be difficult for some, said Brawley. African-American women are nearly four times more likely than whites to forgo treatment for breast cancer, which can include a combination of surgery, chemotherapy and radiation, he said.

Adherence to the radiation regimen is particularly challenging, he explained, because a woman typically has to go five days a week for six weeks. That presents problems for those who must rely on public transportation or work in low-wage jobs that don’t offer generous sick leave benefits.

"It takes them 2½ hours to get there every day, and [the treatment] takes 45 seconds," Brawley said, when describing bus commutes for some residents. "So they figure it's not worth it.”

Those involved in seeking better care for Atlanta’s poor say the lack of insurance coverage also plays a huge role in the problem. Yet, that, too, is tied to race, since twice as many African-Americans than whites are uninsured in Georgia.

“One of the greatest barriers to care in all these states that didn’t expand Medicaid [under the Affordable Care Act] is lack of insurance,” said Brawley. “And it happened in all of the states of the ‘Old Confederacy.’ This is a huge racial insult.”

State Rep. Jason Spencer said Republicans’ opposition to Medicaid expansion “had nothing to do with race." He said whites living in parts of northern Georgia also have higher mortality rates. “The common denominator is education and finances. The race card is a worn-out, tiresome excuse."

'I Didn’t Want To Think About Bad Things'

Austin Gilmore, 60, is emblematic of the patients who don’t have a regular physician and therefore ignore their health needs.

He had a roofing business and lived with his wife in a four-bedroom house with two bathrooms. But he lost his bearings when she died in 2011 from kidney disease. Without insurance and with few economic resources, he didn’t know where to turn for help.

“I didn’t even know I was depressed,” said Gilmore. He started drinking and eventually lost his house and his business.

“I had no livelihood, no job, no place to live. I didn’t want to think about bad things, so I drank,” Gilmore said. He knew he was harming his health.

In September 2016, Gilmore decided he could not ignore his health issues any longer. He went to an emergency room and after several days of treatment was referred to Mercy Care for longer-term care. He has been sober for 19 months.

“I thank God for Mercy Care,” Gilmore said. “I can’t think of where I’d be without them.”

Dr. Kathleen Toomey, district health director for the Fulton County Board of Health, said the county has initiatives to help narrow the gaps. But just as the disparities were not caused by the health care system alone, the problems will not be solved solely by the health care system.

“The ownership is not just on public health, but across all sectors of the community that address social, economic and environmental factors that influence health," Toomey said.

Americans Have Mixed Feelings About The ACA's Future - But Like Their Plans

KFF Health News, April 3, 2018

Only about one-fifth of people who obtain coverage on the individual market were even aware that the mandate penalty had been repealed as of 2019.

This article first appeared April 03, 2018 on Kaiser Health News.

By Rachel Bluth

Most Americans are happy with the insurance they buy on the individual market, yet those same people think the markets are collapsing before their eyes.

A poll by the Kaiser Family Foundation, released Tuesday, found that 61 percent of people enrolled in marketplace plans are satisfied with their insurance choices and that a majority say they are not paying more this year compared with last year’s premium costs.

Yet, more than half of the overall public — 53 percent — also think the Affordable Care Act’s marketplaces are “collapsing.” (Kaiser Health News is an editorially independent program of the foundation.)

Experts have warned that some policy actions supported by the Trump administration would undermine the market, including repealing the penalty for going without insurance and giving people the option to buy short-term plans. Such plans are often less expensive but cover fewer benefits. They are not automatically renewable, and insurers are able to charge people with medical conditions more — or exclude them altogether.

But only about one-fifth of people who obtain coverage on the individual market were even aware that the mandate penalty had been repealed as of 2019, according to the poll. It is still in effect this year.

Nine in 10 enrollees said they would still buy insurance without the penalty, and 34 percent said the mandate was a “major reason” they chose to buy insurance at all.

“They may have been prompted to buy the coverage in the first place because of the mandate,” said Sabrina Corlette, a professor at Georgetown University's Health Policy Institute. “But now that they’ve got it, they clearly value it.”

Most of the people who buy plans because they don’t get coverage through work or the government, 75 percent, said they bought insurance to protect against high medical bills, and 66 percent said peace of mind was a major reason.

In February, President Donald Trump eased some of the restrictions on short-term insurance plans, allowing them to cover people for 12 months instead of three.

Critics worried this alternative would draw people away from traditional insurance plans and weaken the individual market. According to the poll, though, only 12 percent of respondents buying on that market said they’d be interested in buying one of the short-term plans.

Georgetown’s Corlette cautioned that these numbers could change when people are faced with an actual choice next open enrollment season.

“If you look at how these things are marketed, your average consumer will not be able to tell that these products are any different from a traditional health plan,” she said.

Most people said they didn’t face a premium increase this year. Thirty-four percent said their premiums were “about the same” as last year and 23 percent said they actually went down.

That’s not surprising, said Joseph Antos, a resident scholar at the conservative American Enterprise Institute who follows the health industry. Many consumers saw their premium subsidies rise too.

Thirty-five percent of people said one of the major reasons they bought insurance was because government subsidies made it affordable.

The subsidies that people receive, Antos noted, went up to offset the premium increase in many cases, especially if consumers took the advice of experts and shopped around for coverage.

“They’re buying because they feel they need insurance and that their net premiums and deductibles add up to something they’re willing to buy,” Antos said.

The poll was conducted Feb. 15-20 and March 8-13 among 2,534 adults. The margin of sampling error is +/-2 percentage points for the full sample, +/-7 percentage points for all non-group enrollees and +/-9 percentage points for marketplace enrollees.

Medicaid Minus Stigma: In Indian Country, It's Part Of The Fabric Of Life

KFF Health News, April 2, 2018

McKinley County, N.M., has the nation's highest rate of Medicaid enrollment, and people there say it is vital to battle daunting economic and public health challenges.

This article first appeared April 02, 2018 on Kaiser Health News.

By Phil Galewitz/Photos by Heidi de Marco

GALLUP, N.M. — On a crisp sunny day, Tyson Toledo, a precocious 5-year-old boy, hobbled into a private health clinic to have his infected foot examined.

Pediatrician Gayle Harrison told his mother to continue to apply antibiotic ointment and reminded them to come back if the swelling and redness worsened.

The appointment at Rehoboth McKinley Christian Health Care Services’ outpatient center comes at no charge for the Toledo family, who live 30 miles away on the Navajo Nation Reservation. That’s because Tyson is covered by Medicaid, the state-federal health insurance program for the poor.

New Mexico leads all other states in Medicaid enrollment, with 43 percent of its residents on the program. That’s partly because the state has a large Native American population, living in communities historically riven with poverty. The numbers offer an eye-popping snapshot of the promotion of Medicaid expansion since 2013: Nearly a third of the 900,000 New Mexico beneficiaries joined as part of the Affordable Care Act’s option to expand Medicaid.

Kaiser Health News is examining Medicaid’s role in the U.S. as the health care program comes under renewed fire from Republicans who generally want to put the brakes on the program, even as many Democrats credit the expansion with reducing the number of uninsured Americans to historic lows. Conservatives view the costs as prohibitive for state and federal budgets.

Nina Owcharenko, a senior research fellow in health policy with the conservative Heritage Foundation, said the enrollment boost is “not a positive story.” While the high enrollment underscores the pervasive poverty in New Mexico, it also signals surging costs for taxpayers, she said.

“I am growing more concerned about the cost of shifting Medicaid dollars to the federal government and without a budget cap on the program. … That is a dangerous fiscal course for the country,” she said.

“This is a problem that needs to be fixed. … We need to find a way that is more rational and more fiscally sustainable,” said Owcharenko, who was a top Health and Human Services official in 2016.

In Gallup, a city of about 23,000 people, Medicaid is as much a part of the fabric as Native American-crafted jewelry and green chile sauce. Recipients include the waitress at the downtown bar, the clerk at a loan store and the maid at the hotel.

And multigenerational families are common in Gallup and surrounding McKinley County. Tyson’s mother, grandmother, aunt and uncle also are enrolled in Medicaid.

Fifty-two percent of the county’s residents have coverage through the program. That’s the highest rate among U.S. counties with at least 65,000 people, according to a KHN analysis of Census data.

“Pretty much everybody is on Medicaid here,” said Libby Garcia, 36, who lives in a trailer overlooking downtown Gallup.

Garcia, who works as a custodian at a local Head Start agency, quit a second job cleaning businesses because that extra income would put her over the eligibility level for coverage. She can’t afford private insurance, and Medicaid gives her free care at a community health center and insulin and other medicines for her diabetes without out-of-pocket costs, she said.

McKinley, where more than 40 percent of the population lives below the federal poverty level ($12,140 for an individual), is the nation’s only county of at least 65,000 people in which more than half the population is on Medicaid. Nationwide, about 23 percent of Americans are enrolled, with more than 16 million people added since the expansion.

In McKinley County, many residents see Medicaid as vital. There’s no stigma around it, and enrollees and providers speak positively about it.

The heavy concentration of Medicaid in this high-altitude desert is a result of two factors: the high poverty rate and the Indian Health Service’s relentless work to enroll patients in the program.

Large swaths of McKinley County lie within the Navajo Nation, the largest Indian reservation in the United States. Nearly 80 percent of McKinley County’s 75,000 residents are Native American.

Medicaid enrollees in Gallup say the coverage has opened up new opportunities for them to get more timely care, especially surgery and mental health services. It has been vital in combating high rates of obesity, teen birth, suicide and diabetes, according to local health officials.

Outside a local Dollar Tree store, Linda James, 55, who sells jewelry she makes, said Medicaid paid for her son’s braces and her teenage daughter’s drug rehabilitation. “It’s a lifesaver for us,” she said, noting it helps her get quicker care than waiting at Indian Health facilities.

‘Safety Net’ For Indian Health Service

For the Gallup Indian Medical Center — the main Indian Health Service facility in the area — Medicaid has stoked the local budget and eased overcrowding. When patients on Medicaid are treated there, the center is reimbursed by the program. That money supplements the Indian Health Service’s annual federal grant, which is set by Congress.

Last year, Medicaid funding made up 34 percent of the center’s $207 million budget. Among all U.S. hospitals, Medicaid provided only 18.5 percent of revenue. “Medicaid has become the safety net for the Indian Health Service,” said John Ratmeyer, deputy chief of pediatrics at the Gallup Indian Medical Center. “It’s providing an extra pod of money to pay for services not within our hospital system.”

Medicaid this year is projected to add more than $800 million to Indian Health Service hospital funding, supplementing the $4.8 billion in annual federal appropriation.

The medical center in Gallup looks like a relic of the 1960s, with fading-blue exterior walls, sandstone-colored outpatient trailers, cramped nursing stations and hard plastic seats in its emergency room waiting area. The hospital doesn’t have an MRI machine or any designated private patient rooms.

“One of our biggest challenges is just maintaining the building,” said Dr. Kevin Gaines, acting deputy clinical director at the hospital. The extra money coming from patients covered by Medicaid are helping the center pay for a badly needed $13 million modernization of its ER and urgent care unit, he said.

Another problem is a shortage of nurses and doctors, which leads to long wait times for patients — three or four months for primary care appointments or for dental services or eyeglasses. Some patients seeking specialized care need to go 140 miles to Albuquerque, a hardship for many Native Americans, some of whom don’t have access to cars or money for such transportation. But Medicaid will cover some non-emergency transportation for medical appointments.

State Feels The Pinch

The county has a host of medical challenges related to its economic problems. According to a 2016 report sponsored by Rehoboth McKinley, the county’s suicide rate for ages 10 and up is twice the U.S. average, alcohol-related deaths are nearly four times higher than the national rate, and teen birth rates are three times the U.S. average. Average life expectancy in McKinley is 74 years, four years less than the typical U.S. life span.

Without Medicaid covering doctor visits and substance abuse treatment, the situation would likely be worse, said Larry Curley, director of program development for Rehoboth McKinley.

This kind of care doesn’t come cheap. The federal government paid the full cost of the expansion through 2016, but now New Mexico and other states have to pick up a 5 percent share. To deal with rising costs, the state in 2017 began cutting the fees it pays hospitals, doctors and other providers.

Asked about her Medicaid health plan while at a popular doughnut shop, Corrine Rosales, 60, of Gallup, said it’s invaluable for her and her two young nieces, Mya and Destiny. Medicaid pays for her diabetes medications and helped Mya get treated for attention-deficit disorder.

“I don’t know what we would do without it,” she said.

Omissions On Death Certificates Lead To Undercounting Of Opioid Overdoses

KFF Health News, March 29, 2018

The country undercounts opioid-related overdoses by 20-35%, according to a study published in the journal Addiction.

This article first appeared March 29, 2018 on Kaiser Health News.

By Jake Harper, Side Effects Public Media

In a refrigerator in the coroner's office in Marion County, Ind., rows of vials await testing. They contain blood, urine and vitreous, the fluid collected from inside a human eye.

In overdose cases, the fluids may contain clues for investigators.

"We send that off to a toxicology lab to be tested for what we call drugs of abuse," said Alfie Ballew, chief deputy coroner. The results often include drugs such as cocaine, heroin, fentanyl or prescription pharmaceuticals.

After testing, coroners typically make note of the drugs involved in an overdose on the death certificate — but not always.

Standards for how to investigate and report on overdoses vary widely across states and counties. As a result, opioid overdose deaths aren't always captured in the data reported to the federal government. The country undercounts opioid-related overdoses by 20 to 35 percent, according to a study published in February in the journal Addiction.

"We have a real crisis, and one of the things we need to invest in, if we're going to make progress, is getting better information," said Christopher Ruhm, the author of the paper and a health economist at the University of Virginia.

Data from death certificates move from coroners and medical examiners to states and eventually the Centers for Disease Control and Prevention, which publishes reports on overdose counts across the U.S. According to the CDC, more than 42,000 people died from opioid-related overdoses in 2016, a 30 percent increase from the year before.

But that number is only as good as the data states submit to the CDC. Ruhm said the real number of opioid overdose deaths is closer to 50,000. He came to the higher estimate through an analysis of overdoses that weren't linked to specific drugs.

On a death certificate, coroners and medical examiners often leave out exactly which drug or drugs contributed to a death. "In some cases, they're classifying it as a drug death, but they don't list the kind of drug that was involved," said Ruhm. In the years he reviewed in his paper, 1999 to 2015, investigators didn't specify a drug in one-sixth to one-quarter of overdose deaths.

Some states do worse than others. In 14 states, between 20 and 48 percent of all overdose deaths weren't attributed to specific drugs in 2016, according to a breakdown from FiveThirtyEight.

Many overdoses not linked to a specific drug were likely opioid-related, Ruhm said, so the lack of specificity leads to undercounting. According to Ruhm's earlier research published in 2017, Indiana's opioid overdose fatality rate is especially far off. He estimated the state's rate in 2014 was 14.3 overdose deaths per 100,000 people, twice as high as the rate reported that year.

In some states such as Indiana, independent county coroners investigate deaths. Coroners are usually elected, and they aren't necessarily medical professionals. Other states, though, have medical examiners, who are doctors. Some even have a chief medical examiner who oversees death investigations for the whole state.

"States that have centralized oversight with medical examiners tend to do better than those with coroners," said Ruhm.

In some places, death investigators don't list substances on a death certificate because they haven't tested for them. Brad Ray, a policy researcher at Indiana University's School of Public and Environmental Affairs, said toxicology reports cost hundreds of dollars each, which could strain county budgets.

Additionally, toxicology reports are currently optional for Indiana coroners. "So if you're not required to pay for it, and you're not required to report it, why would you?" said Ray.

Indiana's legislature recently passed a bill to standardize how coroners handle suspected overdoses, and Republican Gov. Eric Holcomb is expected to sign it. Starting in July, coroners will have to run toxicology screens and report the results to the state health department. The state will also help cover the added costs.

Data that is more accurate would likely make the opioid problem look worse as the numbers go up. But Ray said realistic data could help the state access federal funds to tackle the opioid epidemic and keep better track of drug problems.

"So we can see when trends are happening. We can see when there tend to be increases in cocaine and meth and decreases in opioids, if that happens," Ray said.

Marion County's Ballew learned at a conference last year that she could help improve the state's data. Her office was already getting toxicology reports for all suspected overdoses, and now her team will list the drugs involved in an overdose on the death certificate.

"We'll say 'drug overdose' or 'drug intoxication,' and then we identify the drugs," she said. "So if it's five drugs that have caused or contributed to the death, then we put those five drugs down."

Ballew said she plans to travel the state and train other coroners to do it the same way.

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