Tagged Public Health

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This Thanksgiving, Carve Out Time For Lively Discourse On End-Of-Life Wishes

The roast turkey and pecan pie may be the same as always, but growing numbers of families plan to add a tradition to their Thanksgiving holiday this week: a frank talk about their wishes for end-of-life care.

Paul Malley, president of Aging with Dignity, the agency behind Five Wishes, a popular living will, says requests for the documents that guide decisions surrounding serious illness and death typically surge starting now.

“We see a bit of a Thanksgiving rush and a bit of a Christmas rush in December,” said Malley, who notes that 30 million copies of Five Wishes have been distributed since 1998.

Turkey dinner with a side dish of death isn’t everyone’s idea of a festive meal. But Malley and other experts in end-of-life talks say the holidays are an ideal time to have hard conversations about final preferences and plans.

“People come home for the holidays,” said Ellen Goodman, the longtime columnist and reporter who co-founded The Conversation Project, which provides kits to kick-start end-of-life discussions. “It’s one of those times when we’re together. It’s something that’s important to talk about.”

While many families will start such discussions for the first time this year, Dr. Patricia Bomba’s family has made the talks a tradition since 1992.

“After the dinner dishes are cleared, the adults in our family stay at the table and talk about what matters most in our lives,” said Bomba, vice president and medical director for geriatrics for Excellus BlueCross BlueShield in New York.

Her family joke is: “There’s no pumpkin pie until you tell me how you want to live until you die,” she added. But the holiday sessions helped guide serious decisions when Bomba’s mother died, she said.

The conversations typically occur between middle-aged children and their elderly parents or grandparents, but they should include all of the adults in a family, Malley said.

“Don’t just put your grandparents in the hot seat,” he said. “It makes for a better and easier family conversation if everyone is in it together.”

The goal is to ensure that people’s preferences are honored. But the talks also can reduce the guilt and depression many family members feel after a loved one dies.

“You can talk about what your values are, who you want to make decisions for you, the care you want, the care you don’t want,” Goodman said.

Often, though, no one wants to broach the subject, even when they think they should. A 2013 Conversation Project survey found that while 90 percent of people said it’s important to have end-of-life discussions with their loved ones, fewer than 30 percent had done so.

Nationwide, about a third of adults in the U.S. have completed written advance directives that spell out wishes for care or designate the person they’d like to carry them out, according to a study in the journal Health Affairs.

Research shows that advance care planning, including the use of written documents, can increase the chances that people’s end-of-life wishes will be followed.

But conversations held over time are key, said Jeannette Koijane, executive director of Kokua Mau, the Hawaii Hospice and Palliative Care Organization in Honolulu.

“Just checking the boxes is not what makes the difference. It’s the conversation that makes the difference,” she said.

Having those conversations in person is important, too, said Malley, who plans to help his parents, who are in their 70s, update their documents over the holiday.

“It’s a natural time to discuss which one of us boys do you want to be your health care agent?” said Malley, the youngest of three brothers. “My parents are teaching us about advance-care planning by doing this together as a family.”

Still, starting such a conversation can be difficult, Goodman said.

“People think if I bring this up with my elderly parents, they’re going to think I want them dead. Or there’s something wrong,” she said.

But if family members can explain that the goal is to understand what matters most to the person at the end of life, the conversation changes. The agency has put together a video that uses humor to show how to break the ice.

“When you say how important it is to you, it’s truly a gift,” Goodman said.

She sees a shift in the culture surrounding end-of-life wishes, even in the five years since The Conversation Project started.

Back then, the specter of “death panels” nearly derailed Obamacare. Today, end-of-life conversations are being paid for by Medicare and books like Atul Gawande’s “Being Mortal” have topped the best-seller list.

“I’m convinced we’re at a tipping point,” Goodman said. “It’s so important to get it right. When you get it wrong, you get something big wrong.”

KHN’s coverage of these topics is supported by Gordon and Betty Moore Foundation and John A. Hartford Foundation

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Got Food Allergies? Add Milk To The Worries For Your Meal

Since her son Matt was an infant, Lynda Mitchell knew he had a milk allergy.

She controlled the symptoms by switching his baby formula. But when he was 1, Halloween proved horrifying. While trick-or-treating in a pumpkin costume, Matt grabbed a chocolate bar and bit through the wrapper. Although he spit out the candy, his violent allergic reaction morphed into a mess of hives, swelling and labored breathing. He ended up in the emergency room.

That was 26 years ago, but Mitchell vividly recalls the fear of that night — and of raising a child with a condition for which there was little information.

“It was really a scary time to have a child with a food allergy,” she said.

Since infancy, Matt Mitchell has lived with a milk allergy. He experienced his first severe allergic reaction after biting a candy bar while trick-or-treating as a pumpkin, according to his mother, Lynda. (Courtesy of Lynda Mitchell)

To this day, Matt is extremely careful about his diet. He carries an EpiPen to thwart a severe attack if he inadvertently eats a milk product.

New research on food allergies finds that milk allergies pose not only a medical, but also a financial burden for families.

In fact, the condition registered the highest average number of services per patient of any food allergy in 2016 — outpacing even the widely publicized allergies to peanuts and shellfish, according to the analysis by Fair Health, a nonprofit that manages a database of private insurance claims and provides cost information to the health care industry and consumers.

Still, the study found that peanuts outranked all other single food allergens in causing severe and sometimes fatal reactions known as anaphylaxis. Peanut allergies accounted for a quarter of medical services given to treat anaphylaxis from 2007 to 2016. Anaphylactic reactions to milk products represented just 5 percent.

The data add to the mounting evidence that the number of people living with a food allergy is on the rise. From 2007 to 2016, medical services related to food allergies listed on private health insurance claims increased by 76 percent, said Dean Sicoli, executive director of communications for Fair Health.

BJ Lanser, director of the pediatric food allergy program at National Jewish Health in Denver, said the causes of those allergies aren’t limited to certain headline-grabbing foods.

While peanuts pose a potentially life-threatening risk for some people, he said, other food allergies can also lead to a lifetime of physical and financial stress.

“We can’t just think about peanuts. We have to think about the other major food allergens,” he said. “This is a disease that carries a significant cost burden.”

Among the findings from the report:

  • The rise in food allergies varied by locale. From 2007 to 2016, the number of services and procedures for those allergies increased by 70 percent in urban settings and more than doubled in rural areas.
  • For children, food allergy claims were more common among boys than girls, but among adults the opposite was true.
  • The effects of allergens also varied by gender. Women and girls were most commonly treated for food additive allergies, but peanuts were the top category for men and boys.
  • Food allergies are typically associated with children, but 34 percent of procedures and services involved a patient older than 18 years.

The report also looked at the costs of treating anaphylactic reactions in food allergies. The number of treatments for these life-threatening occurrences rose 377 percent from 2007 to 2016. But surprisingly, 7 in 10 services were handled in physicians’ offices, while 13 percent were in outpatient facilities (which could include hospital emergency departments). Two percent were specifically labeled as emergency room treatment.

Today, Matt lives independently. He has learned to cook dairy-free dishes and carries an EpiPen with him at all times in case he ingests milk. (Courtesy of Lynda Mitchell)

According to the Food and Drug Administration, more than 90 percent of food allergies are linked to eight foods: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. Milk sensitivities can vary, ranging from a severe allergy like Matt Mitchell’s to an intolerance that causes gastric distress but is not technically a medical allergy.

The Fair Health report found that a peanut allergy is less financially menacing than other foods. Services and treatments related to a peanut allergy averaged $236.73 per patient in 2016. That was a quarter of the cost for a milk product allergy, which averaged $1,043.89 per patient in the same year.

Lanser said the high cost of treating milk allergies is likely related to the high price of milk substitutes, particularly alternative baby formulas. Neither the researchers nor the experts, however, could explain the wide variation in the cost of treating anaphylaxis among food allergies.

Robin Gelburd, president of Fair Health, said the report aims to identify trends in food allergies that could inspire other studies and discoveries. “We never want our data study to be the end of a conversation,” Gelburd said. “Rather, we would want it to be the beginning of a conversation that adds greater understanding to an area.”

Today, Lynda Mitchell is acting chief executive officer of the Asthma and Allergy Foundation of America, a patient advocacy group for people with asthma and allergies. True to tradition, with her son in mind, she intends to prepare Thanksgiving dinner without milk. She will search for a turkey that has not been injected with a solution that could have a milk base. She will make mashed potatoes with chicken stock and margarine but no milk or cream. And she will make her dairy-free pumpkin pie.

“As a parent of a child with a food allergy — especially a young child — you just always have to be surveying the landscape and having that vision going in your head about whether this is going to be a high-risk situation or not,” she said. “And it’s worth it. But it’s just something that parents of children that have food allergies have to do every day.”

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

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Years Before Heading Offshore, Herpes Researcher Experimented On People In U.S.

Three years before launching an offshore herpes vaccine trial, an American researcher vaccinated patients in U.S. hotel rooms in brazen violation of U.S. law, a Kaiser Health News investigation has found.

Southern Illinois University associate professor William Halford administered the shots himself at a Holiday Inn Express and a Crowne Plaza Hotel that were a 15-minute drive from the researcher’s SIU lab. Halford injected at least eight herpes patients on four separate occasions in the summer and fall of 2013 with a virus that he created, according to emails from seven participants and interviews with one participant.

The 2013 experiments raise further questions of misconduct by Halford, who pursued a herpes vaccine for years while working at Southern Illinois University, which claims to have been unaware of his unorthodox research practices.

Halford, who died this summer from cancer, ran a clinical trial out of a house on St. Kitts in 2016 to test the experimental vaccine and did not alert U.S. or St. Kitts and Nevis authorities.

Following a KHN report that Halford completed the 2016 trial with no independent safety oversight, the Department of Health and Human Services demanded the university account for the research.

SIU, in an initial response to U.S. authorities, said the university’s institutional review board found “serious noncompliance with regulatory requirements and institutional policies and procedures.”

SIU, like many universities receiving federal research funds, pledged to follow U.S. standards for all clinical trials.

In 2013, Halford, who was a microbiologist not a physician, noted a need for secrecy in one email to a participant, writing that it would be “suicide” if he became too public about how he was conducting his research.

Many email exchanges with participants in 2013 — asking them to send photographs of rashes, blisters and other reactions — were sent from Halford’s university email account. He used the university phone for communication and he referred to a graduate student as assisting in the experiment and to using the lab.

“Furtive unregulated live virus vaccine injections in a Holiday Inn? This is really, really out there,” said Jonathan Zenilman, a doctor and an expert on sexually transmitted diseases at Johns Hopkins University. “Someone in the university had to know that this stuff was going on. If they didn’t, they should have.”

According to the emails between Halford and the patients and extensive interviews with the participant, Halford did not procure written informed consent as required by federal law when testing a live virus on humans. Medical researchers, such as Halford, may not inject patients without oversight by a physician or a nurse practitioner, Zenilman said.

SIU refused to comment on revelations about Halford’s 2013 experiments.

It has previously said it had no role or responsibility for Halford’s work in 2016 in the Caribbean. The university has maintained it didn’t know about the offshore trial because he pursued that through Rational Vaccines, a company the professor co-founded in 2015.

But criticism has been raised about the university’s ties to Halford’s commercial venture.

SIU, based in Springfield, Ill., shared in a patent on the prospective vaccine with Rational Vaccines, which was formed to market and research the product. The university promoted Halford’s vaccine research on its website. And when a company owned by Peter Thiel, a supporter of President Donald Trump’s, invested millions of dollars into the research this April, SIU publicly trumpeted Halford and Rational Vaccines.

The Food and Drug Administration, which oversees the safety of vaccine research in the U.S., declined to comment on the 2013 experiments. It previously declined comment on the 2016 trial.

Since Halford’s death in June, several participants who received the vaccine in 2013 and 2016 have told KHN they have informed the university about what they fear may be side effects from the vaccine.

One participant who says he received the injections in Illinois fears that the vaccine, which contains a live virus, may have given him a new and different type of herpes he did not have, a scenario that experts who reviewed his medical details for KHN said was possible.

In recent weeks, that participant from Texas and a woman from Colorado who took part in the St. Kitts trial have separately electronically reported to the FDA their possible side effects, also known as “adverse events.”

They said SIU and the FDA have not adequately addressed their inquiries.

“It makes me angry that Halford went ahead with the offshore trial anyway,” said the man from Texas who did not want to be publicly identified because of the sensitive nature of his disease. “I hope more people weren’t hurt.”

Rational Vaccines has vowed to proceed with the research. The company, founded by Halford and Hollywood filmmaker Agustín Fernández III, has said it considers the 2016 trial a success — though it is unclear what data it used to support that claim. In a statement, Rational Vaccines said that Fernández was not involved with Halford’s work before the company was formed but that Fernández was aware of “individuals who experienced positive outcomes from the vaccine.”

“Their stories are what sparked Mr. [Fernández’] future involvement,” the company stated. It did not address specific questions from KHN about the 2013 injections.

A representative for billionaire PayPal co-founder Thiel did not respond to questions about his investment in the vaccine. Thiel and other backers share libertarian political views that are critical of the FDA’s regulations.

The 2013 emails and interview with a participant show Halford began unregulated human experiments while working as an associate professor in the medical school’s department of microbiology.

The Texas patient said he first learned of Halford’s work through a members-only Facebook account. According to the emails, one woman helped Halford recruit patients and organize injections. This woman identified herself to KHN in an email as a herpes patient who was injected with Halford’s vaccine. She claims she was cured as a result.

KHN attempted to contact the other participants who received injections in 2013. They either declined to comment or did not respond.

In the emails, Halford describes some of his methods, including that he was varying the doses — as well as the number of shots. He communicated regularly with participants using a familiar tone.

“Just wanted to pass along that I immunized someone with the higher dose of the HSV-2 vaccine on Monday, and I attach the photos of the injection site at 48 hours to give you and everyone else an idea of what to expect …” he wrote on Sept. 19, 2013. “This individual requested that I give him two immunizations to double the effect … one immunization per leg.”

“Everyone’s vaccines contained ~150 million infectious units of the HSV-2 vaccine strain …” Halford wrote four days later, on Sept. 23, saying the first injection of the group represented about a thirty- to fortyfold increase over what others had received in August 2013.

In the same email, Halford said he believed the experiments were important to demonstrating that his vaccine worked.

“Saturday Sept. 21 definitely represents a milestone in my career,” he wrote. “Don’t know how it will turn out, but I undoubtedly feel like this was a real test of the (a) safety / tolerability of the HSV-2 vaccine and (b) an opportunity to see if it has any therapeutic potential.

“I am indebted to all of you.”

Halford also refers to using his university’s resources in the emails.

“My lab currently consists of myself and 1 graduate student and anything I do with you guys or your blood is extra and on top of what I get paid to do …,” he wrote in a Nov. 3, 2013 email. “If my graduate student gets to it before I do, I will pass along the results.” Attempts by KHN to reach the graduate student, who was not named in the email, were unsuccessful.

When discussing the possible effects of the vaccine in emails dated Oct. 2, 2013, Halford openly speculated about possible results, calling his analysis “nothing more than an educated guess.”

“The proof is in the pudding … let’s see if your problems with outbreaks dial back or not.”

The participants treated Halford with deference and were eager to receive the injections, the emails show.

The Texas man said he did not know how the trial was financially supported, adding that Halford wouldn’t accept money from participants because, as he told them, “it would get him in more trouble if he was ever caught.”

But Halford told participants they could donate money to SIU for his research, the Texas man said. SIU has confirmed that it set up a business account for donations to Halford, but the university has refused to say how the money was used.

When Halford invited them for dinner and drinks at his house, they agreed.  “I’ll do whatever he wants,” the Dallas man wrote about the dinner.

In the emails, the participants, who ranged in age from their 20s to 50s, were enthusiastic about the potential for the vaccine and freedom from often excruciating chronic symptoms. “I do believe [it’s] safe,” the Texas man wrote Halford on Sept. 15.

But months later, on Feb. 24, 2014, he said, he was frightened by a reaction to the vaccine, after his second shot. “I got a large rash on my leg and it burned and swelled,” he wrote to Halford. “… then a blister popped up.”

The Texas man has HSV-1, which usually emerges in sores on the face. Halford’s vaccine was a weakened version of HSV-2, which is genital herpes, according to descriptions he uses in the emails. “I did not think the HSV-2 vaccine strain would be capable of reactivation, but perhaps I will have to reconsider that,” Halford wrote in response in an email.

Anna Wald, a leading herpes expert at the University of Washington, said Halford should have informed the Texas man before testing that he was vulnerable to having side effects because he had a different herpes virus type than the vaccine Halford prepared.

Wald said Halford’s research — without oversight — jeopardized the patients.

“We’re not allowed to do this to guinea pigs in this country let alone human subjects,” Wald said.

But Wald said she could understand the participants’ desire for a chance at a cure. “People underestimate how desperate people with genital HSV are,” she said. “This is what drives even the possibility of a study such as Halford’s.”

SIU continues to be under scrutiny. Jerry Kruse, the dean of SIU’s medical school, responded to the HHS inquiry into the 2016 trial on Oct. 6 and indicated that the university has more to discover.

In his letter, obtained by KHN under the Freedom of Information Act, the dean said “if deemed necessary, SIU will develop an effective corrective action plan.” Some of the letter is redacted.

Several participants from both trials told KHN they have asked SIU for help.

The Colorado woman from the 2016 trial who reported a possible side effect from the vaccine to the FDA said she found university officials “dismissive.”

One participant, a Californian in his 30s, said he wanted the university to continue the vaccine work with safety oversight while “taking responsibility” for any improprieties.

SIU did not adequately address his questions, and he said: “It was obvious they want nothing to do with us.”

KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Gordon and Betty Moore Foundation

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Doctor’s Rx For A Stiff Knee: A Prescription For 90 Percocet Pills

I recently hobbled to the drugstore to pick up painkillers after minor outpatient knee surgery, only to discover that the pharmacist hadn’t yet filled the prescription. My doctor’s order of 90 generic Percocet exceeded the number my insurer would approve, he said. I left a short time later with a bottle containing a smaller number.

When I got home and opened the package to take a pill, I discovered that there were 42 inside.

Talk about using a shotgun to kill a mosquito. I was stiff and sore after the orthopedist fished out a couple of loose pieces of bone and cartilage from my left knee. But on a pain scale of 0 to 10, I was a 4, tops. I probably could have gotten by with a much less potent drug than a painkiller like Percocet, which contains a combination of the opioid oxycodone and the pain reliever acetaminophen, the active ingredient found in over-the-counter Tylenol.

When I went in for my follow-up appointment a week after surgery, I asked my orthopedist about those 90 pills.

“If you had real surgery like a knee replacement you wouldn’t think it was so many,” he said, adding that the electronic prescribing system set the default at 90. So when he types in a prescription for Percocet, that’s the quantity the system orders.

Such standard orders can be overridden, but that’s an extra step for a busy physician and takes time.

As public health officials grapple with how to slow the growing opioid epidemic — which claims 91 lives each day, according to federal statistics — the over-prescription of narcotics after even minor surgery is coming under new scrutiny.

While patients are today often given opioids to manage post-operative pain, a large supply of pills may open the door to opioid misuse, either by the patients themselves or others in the family or community who get access to the leftovers.

Post-surgical prescriptions for 45, 60 or 90 pills are “incredibly common,” said Dr. Chad Brummett, an anesthesiologist and pain physician at the University of Michigan Medical School.

Last year, the Centers for Disease Control and Prevention released a general guideline saying that clinicians who prescribe opioids to treat acute pain should use the lowest effective dose and limit the duration to no longer than seven days.

But more detailed guidance is necessary, clinicians say.

“There really aren’t clear guidelines, especially for surgery and dentistry,” Dr. Brummett said. “It’s often based on what their chief resident taught them along the way, or an event in their career that made them prescribe a certain amount.” Or, as in my case, an automated program that makes prescribing more pills simpler than prescribing fewer.

Brummett is co-director of a Michigan program that has released recommendations for post-surgical opioid prescribing for a growing list of procedures.

To determine the extent to which surgery may lead to longer-term opioid use, Brummett and his colleagues examined the insurance claims of 36,177 adults who had surgery in 2013 or 2014 for which they received an opioid prescription. None of the patients had prescriptions for opioids during the prior year.

The study, published online in JAMA Surgery in June, found that three to six months after surgery, roughly 6 percent of patients were still using opioids, having filled at least one new prescription for the drug. The figures were similar whether they had major or minor surgery. By comparison, the rate of opioid use for a control group that did not have surgery was just 0.4 percent.

Some insurers and state regulators have increasingly stepped in to limit opioid prescriptions. Insurers routinely monitor doctors’ prescribing patterns and limit the quantity of pills or the dosage of opioid prescriptions, said Dania Palanker, an assistant research professor at Georgetown University’s Center on Health Insurance Reforms who co-authored a study on insurers’ response to the opioid crisis.

At least two dozen states have passed laws or rules in just the past few years aimed at regulating the use of opioids.

In my state of New York, Gov. Andrew Cuomo last year signed legislation that reduced the initial opioid prescription limit for acute pain from 30 days to no more than a seven-day supply.

As my experience demonstrated, however, a seven-day limit (those 42 pills in my case) can still result in patients receiving many more pills than they need. (For those who find themselves in a similar situation with excess pills, here is the safe and proper way to dispose of them.)

Still, some caregivers and patients worry that all this focus on overprescribing may scare physicians away from prescribing opioids at all, even when they’re appropriate.

“That’s my concern, that people are so afraid of things and taking it to such an extreme that patient care suffers,” said Dr. Edward Michna, an anesthesiologist and pain management physician at Brigham and Women’s Hospital in Boston who is on the board of the American Pain Society, a research and education group for pain management professionals. Michna has been a paid consultant to numerous pharmaceutical companies, some of which manufacture narcotics.

But other doctors say that one of the reasons doctors call in orders for lots of pills is their convenience.

“When you land on the front lines, you hear, ‘I like to write for 30 or 60 pills because that way they won’t call in the middle of the night’ ” for a refill, said Dr. Martin Makary, a professor of surgery and health policy at Johns Hopkins School of Medicine.

Makary is spearheading a consortium of Hopkins clinicians and patients that provides specific guidelines for post-surgical opioid use. The program, part of a larger effort to identify areas of overtreatment in health care, also identifies outlier prescribers nationwide to encourage them to change their prescribing habits.

The Hopkins group doesn’t have an opioid recommendation for my surgery. The closest procedure on their website is arthroscopic surgery to partially remove a torn piece of cartilage in the knee called the meniscus.  The post-surgical opioid recommendation following that surgery: 12 tablets.

Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.

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