The Secret To Chronic Happiness As You Age

By all rights, Fletcher Hall should not be happy.

At 76, the retired trade association manager has endured three heart attacks and eight heart bypass operations. He’s had four stents and a balloon inserted in his heart. He has diabetes, glaucoma, osteoarthritis in both knees and diabetic neuropathy in both legs. He can’t drive. He can’t travel much. He can’t see very well. And his heart condition severely limits his ability to exercise. On a good day, he can walk about 10 yards before needing to rest.

Yet the Brooklandville, Md., resident insists he’s a genuinely happy guy — in part, because he appreciates what he can do. “There’s no question that as age impinges on your life, you do have ‘black dog’ days,” said Hall. “I fight aging every day. But I never, ever give up. You have to work at keeping happy.”

At 76, Fletcher Hall has a variety of medical conditions that dictate what he cannot do in life, yet he’s focused on what he can do. “You have to work at keeping happy,” he says. (Courtesy of Fletcher Hall)

Hall focuses on the things that bring him joy: writing and listening to music and audiobooks. By juggling those pastimes throughout the day — every day — he ultimately feels a sense of contentment. “Every one of those things requires that I use my mind — which is a good thing.”

Geriatric experts agree that Hall has pretty much figured out the right formula. “You have to be willing to accept your new reality — and move forward,” said Dr. Susan Lehmann, director of the geriatric psychiatry day program at Johns Hopkins University School of Medicine. “Aim to have the best life you can at where you are right now.”

Living with chronic disease often complicates life. The majority of adults 65 and over have multiple chronic conditions that contribute to frailty and disability, according to a 2013-14 report from the Centers for Disease Control and Prevention. The percentage of chronic conditions among people 65 and over has increased over time, too. The percentage of people reporting hypertension, asthma, cancer and diabetes was higher in 201314 than in 1997-98, reports the CDC.

Chronic conditions can have a devastating impact on both men and women, according to the CDC report. About 57 percent of women and 55 percent of men age 65 and up reported hypertension. Another 54 percent of women and 43 percent of men reported arthritis. And a full 35 percent of men and 25 percent of women reported dealing with heart disease. At the same time, older women were more likely to report clinically relevant depressive symptoms than were older men. In 2014, 15 percent of women 65 and older reported depressive symptoms, compared with 10 percent of men.

Chronic pain, in fact, more frequently leads to depression than does anxiety, said Dr. Kathleen Franco, associate dean at the Cleveland Clinic Lerner College of Medicine. That depression then leads to additional pain and suffering, she said. “So you have an emotional and physical component.”

That’s why Hall clings dearly to his greatest passion: writing. When he retired at 65, his original plan was to travel with his wife, Tracey. His physical limitations curbed those goals, so he circled back to what has brought him the most happiness. He stays engaged in daily news by writing for two blogs — including one at-large column in which he espouses what he calls his “compassionate conservative” values.

12 Tips For Older Adults To Stay Happy
  1. Accept your reality and move forward from there.
  2. Don’t compare how you feel now to when you were younger.
  3. Focus on maximizing what you can do, not what you can’t.
  4. Prioritize the things that are truly important to you.
  5. Don’t be afraid to ask for help.
  6. Plan your day around maximizing your energy.
  7. Stay connected with friends and family.
  8. Be proactive and advocate for your own health care.
  9. Continue to exercise — even while seated.
  10. Be grateful for the small things.
  11. Have a purpose in your life.
  12. Find a way — even a small way — to help others.

Hall also adores reading, even though glaucoma has made it all but impossible. Not one to give up, he uses his Amazon Echo smart speaker to order audiobooks. He loves sitting on his balcony in the sunshine and listening to books like The Guns of August. Similarly, he enjoys streaming both classical and country music, especially the Oak Ridge Boys and the country rock group Alabama.

Hall also has learned to use Alexa, the Echo’s built-in digital assistant, to help with seemingly simple tasks that are difficult with poor eyesight. To tell time, he simply asks Alexa.

Beyond that, he avoids getting trapped in any frustration loops, such as trying to troubleshoot computer issues. During a recent technological tussle, he simply shut down the machine and turned on PBS and Charlie Rose. “Watching that show keeps my mind active,” he said. After taking time to de-stress, he was able to solve the tech issue.

Hall finds some excuse to get out of his house every day. Sometimes he runs an errand. Or he’ll meet a friend for lunch. As a bird lover, he might just sit in a park listening to birds singing. “If I can combine a pleasant venue with the sound of bird symphonies, I’m a happy camper,” he said.

This is Hall’s version of what some experts call “mindfulness.” Mindfulness, which often involves deep, slow breathing that’s aimed at lowering your heart rate and calming you down, can be highly effective on older, ailing people, said Franco. “It’s simple. It doesn’t cost anything. You can do it and no one even knows you’re doing it.”

One other thing often works like magic: helping others. “Once you start giving to others, you tend not to get stuck in your own aches and pains,” said Franco.

Four years ago, Anne McKinley’s husband of 59 years, Cameron, died. This is one of the last photos of them together, sitting in the back seat of a car on the way to view aspen trees in Colorado. (Courtesy of Carol McKinley)

Anne McKinley knows this firsthand. Even at 85, she still volunteers for an aging advocacy group and sits on its board of directors.

McKinley copes with the debilitating effects of lifelong scoliosis. She, too, battles glaucoma, and her visual perception difficulties affect her balance. She’s had both knees replaced and more recently needed emergency surgery for an infection she contracted in the hospital following parathyroid surgery, which also affected her vocal cords.

The Evergreen, Colo., resident said that keeping a very positive attitude — and constantly reaching out to family and friends — keeps her content.

“Feeling like I have control of my life is very important,” she said. “The key is not to feel rushed. I can accomplish one thing in a day and feel good about it.”

It’s been a tough road since her husband, Cameron, died four years ago after 59 years of marriage. But with her master’s degree in social work and experience as a social worker, she knew how to utilize social services for older people in her community. That includes one service that performs housekeeping and other chores for a modest fee.

McKinley still visits family in Florida — though she must use a cane or walker to get around. Her grandchildren frequently come to visit, “and we feast whenever they do,” she added, typically on the cookies and pies she loves to bake. Above all, she said, she’s always getting out of the house. She gets her hair cut every week. “It’s my best remaining feature,” she said.

Then, there’s her Siamese cat, Frankie, who joins McKinley every evening at 6 p.m. to watch the evening news while McKinley makes herself a snack and a martini. “My favorite part is the olives,” she said.

And, yes, she expresses how particularly grateful she is for what she has — including a home with a 20-foot-high ceiling on an 18-acre site, where she can look out any window and see the surrounding beauty.

The real key to happiness at every age and stage — particularly old age — is not material things, but gratitude for life’s simple blessings, like laughter among friends or watching a sunset with a loved one, said Lehmann, the Johns Hopkins doctor. “It’s the small things in life that end up mattering most of all.”

KHN’s coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation and its coverage of aging and long-term care issues is supported by The SCAN Foundation.

Categories: Aging

Tags: Wellness

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St. Kitts Launches Probe Of Herpes Vaccine Tests On U.S. Patients

The government of St. Kitts and Nevis has launched an investigation into the clinical trial for a herpes vaccine by an American company because it said its officials were not notified about the experiments.

The vaccine research has sparked controversy because the lead investigator, a professor with Southern Illinois University, and the U.S. company he co-founded did not rely on traditional U.S. safety oversight while testing the vaccine last year on mostly American participants on the Caribbean island of St. Kitts.

The trial received financial backing from a former Hollywood filmmaker who has asserted the vaccine was highly successful in stopping herpes outbreaks. Since then, a group of investors, including Donald Trump supporter Peter Thiel, have backed the ongoing vaccine research with a $7 million investment that could include additional clinical trials in Mexico and Australia.

Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing on the 20 human subjects. Now, the government of St. Kitts and Nevis says that the researchers also did not officially seek permission to test the vaccine, which took place from April to August 2016.

“The Ministry of Health states categorically that neither the Cabinet, the Ministry of Health, the office of Chief Medical Officer (CMO) nor the St. Kitts and Nevis Medical Board has ever been approached on this project,” said the government press release sent out Wednesday night. “By extension, none of these agencies has approved such a venture.”

Agustín Fernández III, the co-founder of Rational Vaccines, the company that oversaw the vaccine testing, said his partner, William Halford, told him that he notified the St. Kitts government. Halford, who was the lead investigator on the research, died of cancer in June and Fernández said he did not have any other details about whom Halford might have talked to.

“I don’t know exactly,” Fernández wrote in an email Thursday. “[Halford] said he spoke to local authorities.”

Southern Illinois University did not immediately respond Thursday to questions about the research but told a reporter previously that Halford was not doing the research as part of his job at the university.

U.S. researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.

In the St. Kitts press release, the Ministry of Health and Social Services said it “will always ensure that all research involving human participants follow international standards which protect the safety and security of persons involved.”

To ensure this happens, an ethics review committee is supposed to vet medical research protocols “in keeping with international best practices.”

Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected. Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Many patients have no symptoms, though a small number suffer greatly. The virus is primarily spread through sexual contact but also can be released through the skin.

However, Rational Vaccines downplayed safety concerns, asserting there was little risk the participants would be harmed because they had herpes already. Fernández has said Halford took the necessary precautions during the trial. Halford also told him he manufactured the vaccine outside the United States, Fernández said Thursday.

“I don’t know how he [got] it there,” Fernández said in the email. He added that the doses were already in St. Kitts when he agreed to fund the trial.

SIU did not immediately respond to questions about whether it knew if Halford sought permission from St. Kitts officials.

Rational Vaccines was established in February 2015 and the company entered into its patent agreement with the university later that year, Fernández said.

A university spokeswoman earlier said the university first learned about the trial in October 2016 — after it had ended. The spokeswoman added that Halford didn’t need to bring the trial to SIU’s IRB because the trial wasn’t overseen by the university.

However, after a reporter raised questions about the lack of an IRB, the university launched a review of “internal processes to assure we are following best practices.”

Depending on how Halford transported the vaccine, he might have been required to seek approval from St. Kitts customs officials, said Dr. Patrick Martin, St. Kitts and Nevis’ chief medical officer until June 2016. Martin, who had been in that position since 2004, said he never heard from Halford or any other member of the company, although he should have been notified. “Where did the testing of the herpes vaccine take place?” Martin asked.

Such questions reverberated after news broke of the vaccine trial. The former St. Kitts and Nevis prime minister, Dr. Denzil Douglas, in a press release said: “Where [were] the materials, the drugs, the storage equipment for these vaccines housed? Were there appropriate customs declarations?”

Martin said he had to shut down another unauthorized research site, which was testing a stem cell product around the same time.

“We are a country of rules and regulations,” he said. ”Researchers can’t just do whatever they like without notifying the government or going to an IRB.”

The St. Kitts official now in charge of such matters, Dr. Hazel Laws, did not return repeated phone calls. An employee who answered the phone said it was unlikely she or any other official would call back because “the press release spoke for itself.”

American scientists called for more rigorous clinical trial oversight in the wake of Nazi atrocities involving human experiments but the U.S. did not require IRBs until the 1970s.

Steven Joffe, chief of the division of medical ethics at the University of Pennsylvania Perelman School of Medicine, said for research to be considered ethical “the study must be conducted in accordance with international standards for human subjects research.”

That includes approval by an institutional review board, research ethics committee or the equivalent.

“Legally, it must comply with the laws and regulations of the country,” he added.

This story was updated Aug. 31 to reflect that a statement attributed to Dr. Patrick Martin came from Dr. Denzil Douglas.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Categories: Health Industry, Pharmaceuticals, Public Health

Tags: Clinical Trials, Patient Safety, Vaccines

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Arizona accuses Insys of fraudulent opioid marketing scheme

(Reuters) – Arizona’s attorney general sued Insys Therapeutics Inc on Thursday, accusing the drugmaker of engaging in a fraudulent marketing scheme aimed at increasing sales of a fentanyl-based cancer pain medicine.

The lawsuit by Arizona Attorney General Mark Brnovich in Maricopa County Superior Court in Phoenix comes during a series of federal and state investigations centered on Insys’ Subsys opioid drug.

The lawsuit, filed in Maricopa County Superior Court in Phoenix, accused Insys of paying doctors sham speaker fees in exchange for writing prescriptions of Subsys without regard for the health of patients.

The lawsuit also named three Arizona doctors as defendants who it said collected speaker fees from Insys while writing prescriptions that generated more than $33 million in sales of Subsys, or 64 percent of all sales of the drug in the state.

“We need to put a stop to the unethical and greedy behavior in the pharmaceutical industry that is fueling the opioid crisis in our state,” Brnovich said in a statement.

Insys did not immediately respond to a request for comment. Lawyers for the three doctors – Steve Fanto, Nikesh Seth and Sheldon Gingerich – could not be immediately identified.

The case is the latest to center on Subsys, an under-the-tongue spray intended for cancer patients that contains fentanyl, a highly addictive and regulated synthetic opioid.

In December, federal prosecutors in Boston charged six former Insys executives and managers, including ex-Chief Executive Michael Babich, with engaging in a scheme to bribe doctors to prescribe Subsys.

Babich and his co-defendants have pleaded not guilty. Federal charges have also been filed in several other states against other ex-Insys employees and medical practitioners who prescribed Subsys.

Insys has said it is in talks with the U.S. Justice Department to resolve the federal probe.

The Arizona-based drugmaker previously agreed to pay a combined $8.95 million to resolve investigations by attorneys general in Oregon, New Hampshire and Illinois.

Reporting by Nate Raymond in Boston; Editing by Lisa Von Ahn

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Amazon hit with lawsuit over eclipse glasses

NEW YORK (Reuters) – Amazon.com (AMZN.O) has been hit with a proposed class action lawsuit by a couple who claims defective eclipse glasses purchased through the online retailer damaged their eyes.

In the lawsuit, filed in federal court in South Carolina on Tuesday evening, Corey Payne and his fiancée, Kayla Harris, said they purchased a three-pack of eclipse glasses on Amazon in early August, assuming that the glasses would allow them to safely view the United States’ first coast-to-coast total solar eclipse in a century on Aug. 21.

Later that day, Payne and Harris began to experience headaches and eye watering. In the following days, they developed vision impairment, including blurriness and distorted vision, their lawsuit said.

Amazon did not immediately respond to a request for comment on the lawsuit.

The couple said they did not look into the sky without wearing the glasses when they viewed the eclipse.

Starting on August 10, Amazon said it began to email customers to issue a recall of potentially hazardous solar eclipse glasses it was unable to verify as having been manufactured by reputable companies. Amazon did not disclose the scale of the recall or a list of affected vendors.

Payne and Harris said they did not receive notice of the recall. They are seeking to represent other customers who never received a warning from Amazon and suffered similar injuries from the company’s alleged negligence.

Experts cautioned the public to steer clear of unsafe counterfeits flooding the United States in the runup to the event. While no data exists for how many eclipse glasses were in circulation overall, shady distributors of purportedly solar-safe shades abound on the Internet, experts said.

Reporting by Tina Bellon; Editing by Anthony Lin and Cynthia Osterman

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Autoimmune diseases increase cardiovascular and mortality risk

Autoimmune diseases significantly increase cardiovascular risk as well as overall mortality, new research confirms. This is particularly pronounced in people suffering rheumatoid arthritis or systemic lupus erythematosus. In addition, it has been seen that inflammatory bowel diseases, such as Crohn’s or ulcerative colitis, increase the risk of stroke and death through any cause.
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Pioneering Cancer Gene Therapy Gets Green Light — And $475,000 Price Tag

The country’s first approved gene therapy — approved Wednesday to fight leukemia that resists standard therapies — will cost $475,000 for a one-time treatment, its manufacturer announced.

Switzerland-based Novartis, which makes the innovative therapy, announced that the drug will cost nothing if patients fail to benefit in the first month.

The Food and Drug Administration approved the therapy, called Kymriah, in children and young adults with acute lymphoblastic leukemia whose disease has come back in spite of previous treatments. These patients typically have a poor prognosis, surviving three to nine months, according to Novartis.

In the study that led to Kymriah’s approval, 83 percent of patients went into remission within three months, according to the FDA. Novartis estimates about 600 patients a year would be eligible for the treatment, which belongs to a class of drugs known as CAR T-cell therapies.

Kymriah treats cancer in an entirely new way. The individualized approach involves harvesting cancer patients’ immune cells, genetically engineering them, then returning them to patients’ bodies. The genetic engineering process aims to rev up patients’ immune systems to better fight cancer.

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“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said Dr. Scott Gottlieb, the FDA commissioner. “New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses.”

Novartis officials said it is working with 20 hospitals to provide Kymriah within a month. Eventually, the therapy will be offered at 32 sites, the company said. The first patients could be treated within days. The company is carefully training hospitals and staff to provide the treatment, which can cause a life-threatening immune reaction, as well as long-term complications.

Novartis said that it priced its drug based on several considerations. British health authorities have said a price of $649,000 for a one-time treatment would be cost-effective given Kymriah’s significant benefits. Novartis also considered the cost of bone-marrow transplants, which are currently given to many leukemia patients whose cancer relapses. Those transplants can cost up to $800,000, Novartis said.

Dr. Stephan Grupp, a researcher at Children’s Hospital of Philadelphia who helped test Kymriah in early studies, said he hopes the therapy could eventually replace bone-marrow transplants for these young patients. It would spare them from the serious and long-term side effects of a transplant, including the immune system attacking transplanted cells, he said. Some children who’ve received Kymriah have already received a transplant. For others, Kymriah serves as a “bridge to transplant,” keeping them alive longer enough to undergo this therapy.

An advocacy group called Patients for Affordable Drugs recently met with officials at Novartis to ask it to set a “fair” price for the drug, whose early development was supported by $200 million in federal research grants.

David Mitchell, a multiple myeloma patient and president of the advocacy group, described the drug’s price tag as “excessive.”

“Novartis should not get credit for bringing a $475,000 drug to market and claiming they could have charged people a lot more,” he said. “The drug pricing system in America is completely broken. Until policy in this country changes, the vicious cycle of patients struggling under high drug prices will continue.”

The FDA also is considering a CAR T-cell therapy from California-based Kite Pharma. Gilead Sciences — which has been criticized for the $84,000 price tag of its hepatitis C drug — announced Monday that it will buy Kite for $11.9 billion.

Novartis officials said that they will offer a patient assistance program to help people with out-of-pocket costs.

Experts have noted that hidden costs could further add to patients’ financial burdens.

Beyond the cost of the procedure, patients would need to pay for traditional chemotherapy, which is given before CAR T-cell therapy to improve its odds of success. They would also have to foot the bill for travel and lodging to one of the hospitals equipped to provide the high-tech treatment.

Because patients can develop life-threatening side effects weeks after the procedure, doctors will ask patients to stay within two hours of the hospital for up to a month. In New York, even budget hotels cost more than $200 a night — an expense not typically covered by insurance. Patients who develop a dangerous complication, in which the immune system overreacts and attacks vital organs, might need coverage for emergency room care, as well as lengthy stays in the intensive care unit.

Doctors don’t yet know what the full range of long-term side effects will be. CAR T-cell therapies can damage healthy immune cells, including the cells that produce the antibodies that fight disease. Some patients will need long-term treatments with a product called intravenous immunoglobulin, which provides the antibodies that patients need to prevent infection.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Categories: Cost and Quality, Health Industry, Pharmaceuticals

Tags: Cancer

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5 Outside-The-Box Ideas For Fixing The Individual Insurance Market

With Republican efforts to “repeal and replace” the Affordable Care Act stalled, tentative bipartisan initiatives are in the works to shore up the fragile individual insurance market that serves roughly 17 million Americans.

The Senate Health, Education, Labor and Pensions Committee launches hearings the week Congress returns in September on “stabilizing premiums in the individual insurance market” that will feature state governors and insurance commissioners. A bipartisan group in the House is also working to come up with compromise proposals.

Both before and after implementation of the federal health law, this market — serving people who don’t get coverage through work or the government — has proved problematic. Before the law, many people with preexisting health conditions could not get insurance at any price. Now, consumers in the individual market often face higher out-of-pocket costs and fewer choices of health care providers and insurers than in past years. More than 12 million people buy that insurance through the ACA’s marketplaces, while another 5 million buy it outside of the exchanges.

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Policymakers generally agree on what immediate efforts to stabilize the market might include. At the top of most lists is ensuring federal payment of subsidies to insurers to pay the out-of-pocket expenses — such as deductibles and copayments — to protect customers with the lowest incomes. Insurers also want the federal government to continue enforcing the requirement that most Americans either have insurance or pay a tax penalty, and continuing efforts to get uninsured people to sign up for coverage during the upcoming open enrollment period, from Nov. 1 to Dec. 15. Those efforts are essential, insurers say, to help keep healthy customers in their risk pools to defray the costs of beneficiaries with medical needs.

But what about ideas that go beyond the oft-repeated ones? Here are five proposals that are more controversial but generating buzz.

1. Allow people into Medicare starting at age 55.

Getting slightly younger people into Medicare, the federal program for the disabled and Americans 65 and older, is a longtime goal of Democrats. It dates at least to the Clinton administration and was nearly included in the Affordable Care Act in 2010. A Medicare buy-in is not exactly the same as a “public option,” which many Democrats, including former President Barack Obama, have embraced. A true public option would offer government coverage to those of any age.

Lowering the age for Medicare eligibility (whether by allowing people to purchase coverage early or letting them join on the same terms as those aged 65) is controversial. Some Democrats support it as a first step toward a single-payer, Medicare-for-All system. Most Republicans oppose it on those same grounds — as a step toward government-run health care.

But proponents argue it would help the current individual market by excluding the oldest people, thereby lowering the average age of the risk pool. Since older patients, on average, cost more to insure, the change could lower premiums for everyone left in the ACA market. That’s the stated goal of a Medicare buy-in bill introduced earlier this month by Sen. Debbie Stabenow (D-Mich.) and seven other Democratic senators. That bill would allow Obamacare market customers ages 55-64 to purchase Medicare coverage instead, but would also let them use ACA tax credits if they are eligible for those. The cost of such policies, however, has not been worked out.

“The way we’ve structured it actually both helps Medicare by having younger people in that pool, and it helps private insurance by taking higher-cost individuals out of their pool,” Stabenow told The Detroit News.

Conservative health analysts don’t buy that, though. “This is just a way of saying we’re going to take these people out of the exchanges and put them where there are bigger subsidies,” said Joseph Antos at the conservative-leaning American Enterprise Institute (AEI).

2. Allow people to ‘buy in’ to Medicaid.

An alternative to letting people buy in to Medicare is letting them buy in to Medicaid, the joint federal-state program for those with low incomes.

Medicaid buy-ins already exist — for example, in 2005 Congress passed the Family Opportunity Act, which allows families earning up to three times the poverty level to purchase Medicaid coverage for their disabled children who aren’t otherwise eligible. Medicaid has typically provided richer benefits for those with disabilities than private health insurance.

Earlier this year, Gov. Brian Sandoval (R-Nev.) vetoed a bill that would have allowed Nevada residents to buy Medicaid coverage through the state’s insurance exchange.

Now Sen. Brian Schatz (D-Hawaii) is pushing a federal Medicaid buy-in plan, which he described to Vox.com last week. It would give states the option to allow people with incomes over current Medicaid eligibility thresholds to pay a premium to join the program. Like the Medicare buy-in bill, it would allow those who qualify for federal tax credits to use them to pay the premiums.

The proposal would also raise the amounts Medicaid pays to doctors, hospitals and other health care providers to the same level as it pays for Medicare patients. Traditionally, low Medicaid payment rates have kept many doctors, particularly specialists, from taking Medicaid.

As with the Medicare expansion, the idea of a further Medicaid expansion does not sit well with conservative policy analysts. “It’s completely unworkable,” Avik Roy of the Foundation for Research on Equal Opportunity, told Vox. He predicted it would raise Medicaid spending by $2 trillion over 10 years.

3. Get younger adults off their parents’ insurance and back into the individual market.

Allowing young adults up to age 26 to stay on their parents’ health plans is unquestionably one of the most popular ACA provisions. Democrats have touted it proudly while Republicans have dared not touch it in almost any of their overhaul proposals.

Yet what has been a boon to 3 million young adults (and a relief to their parents) has come at a cost to the individual marketplace itself, where only an estimated 28 percent of those buying coverage in state exchanges were ages 18-34 in 2016. That is well below the 40 percent most analysts said was necessary to keep the market stable.

“Frankly, it was really stupid,” to keep those young people out of the individual market, said Antos of AEI. The result has been a lack of people in the risk pool who are “young, healthy and whose parents will pay their premiums.”

But rolling back that piece of the law might be nearly impossible, said Antos, because “this is a middle-class giveaway.”

4. Require insurers who participate in other government programs to offer marketplace coverage.

One clear shortcoming of the individual marketplace is a lack of insurer competition, particularly in rural areas. While there appear to be no counties left with no company offering coverage for the coming year, the percentage of counties with only one insurer seems certain to rise from 2017’s 33 percent.

In an effort to more strongly encourage private companies to step up and offer coverage, several analysts have suggested tying access to participation in other government programs to a willingness to offer individual ACA policies as well.

For example, some have suggested insurers be required to provide policies in the marketplaces as a condition of being able to offer coverage to federal workers. Others have suggested that private insurers who offer profitable Medicare Advantage plans could also be required to offer individual exchange coverage, although the same rural areas with a lack of private individual market insurers also tend to lack Medicare Advantage coverage.

5. Let people use HSA contributions to pay health insurance premiums.

A little-noticed provision in one of the versions of the Senate GOP health bill that failed to pass in July would have allowed people to use money from tax-preferred health savings accounts (HSAs) to pay their insurance premiums. A little-noticed proposal from a group of ideologically diverse health care experts included a similar idea.

HSAs are linked to high-deductible insurance plans, and consumers use the money in the account to pay their out-of-pocket expenses. The money put into the account and the earnings are not taxable.

With a few exceptions, people with HSAs have not been allowed to use those funds to pay monthly premiums. But the change would be one way to provide relief to people who buy their own insurance, earn too much to get federal premium subsidies and cannot deduct premiums from their taxes because they are not technically self-employed. Such people, though likely small in number, have been disproportionately hurt by rising premiums in the individual market since the ACA took full effect.

Still, the change would involve some trade-offs.

Roy Ramthun, who helped design HSAs as a Senate staffer in the early 2000s and helped implement them while at the Treasury Department during the George W. Bush administration, said that, generally, “Republicans have preferred to subsidize insurance premiums through tax deductions and credits and leave the HSA for out-of-pocket expenses.” Allowing premiums to be paid from HSA funds, he said, “could eat up the entire balance of the account and leave nothing for out-of-pocket expenses.” There are limits to how much money can be put into an HSA. For 2017, the maximum is $3,400 for an individual and $6,750 for a family.

Categories: Cost and Quality, Insurance, Medicaid, Medicare, Repeal And Replace Watch, The Health Law

Tags: Health Savings Accounts, Out-Of-Pocket Costs, Premiums, U.S. Congress

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Egypt promotes birth control to fight rapid population growth

CAIRO (Reuters) – Egypt is pushing to educate people in rural areas on birth control and family planning in a bid to slow a population growth rate that President Abdel Fattah al-Sisi said poses a threat to national development.

The country is already the most populous in the Arab world with 93 million citizens and is set to grow to 128 million by 2030 if fertility rates of 4.0 births per thousand women continue, according to government figures.

In 2016, Egypt saw the birth of 2.6 million babies, the country’s statistics agency CAPMAS said last month.

“The two biggest dangers that Egypt faces throughout its history are terrorism and population growth and this challenge decreases Egypt’s chances of moving forward,” Sisi told a youth conference last month.

Egypt’s health minister last month started Operation Lifeline, a strategy to reduce the birth rate to 2.4 and save the government up to 200 billion Egyptian pounds ($11.3 billion) by 2030.

Its target is rural areas where many view large families as a source of economic strength and there is resistance to birth control because of a belief that it is unlawful under Islam to aim to conceive a specific number of children.

Egypt’s Al-Azhar university, a 1,000-year-old seat of Islamic learning, endorsed the ministry’s plan and said family planning is not forbidden.

Ousted President Hosni Mubarak and his wife Suzanne set up a population control program decades ago but this is the first time the government says it is motivated by concern that rapid expansion saps the economy.

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A general view of clustered buildings in Cairo, Egypt August 30, 2017.Mohamed Abd El Ghany

The health ministry said it would deploy 12,000 family planning advocates to 18 rural provinces but gave no details of how it would attract more women to the program.

The ministry runs nearly 6,000 family planning clinics where women receive free check-ups and can buy heavily subsidized contraceptives ranging from condoms at 0.10 Egyptian pounds to copper Intrauterine Devices at 2 Egyptian pounds.

“Given how expensive the cost of living has become and the increase in prices, people have started becoming more aware. They know they can afford to have one or two children, but no more,” Ahlam Saad, a nurse at a government-run family planning clinic on the outskirts of Cairo, told Reuters.

A doctor is seen at a family planning clinic in Cairo, Egypt August 13, 2017.Nadine Awadalla

Inflation has surged in Egypt to record highs over the past year after the country floated its currency in November, a move which drove down the value of the pound.

That drop created a shortage of medicines in pharmacies across Egypt, as scores of products including contraceptives became unprofitable to produce or import.

“My fiance and I decided that we want to delay having a baby, I want to continue my studies and we’re just not ready,” said 30-year-old Sherin who sat in the waiting room with a score of others.

In line with government plans to reduce reliance on imports, the ministry contracted Acdima International, a subsidiary of the privately owned Arab Company for Drug Industries and Medical Appliances, to source locally produced hormonal contraceptives.

The deal saves the government millions of dollars and covers 65 percent of local demand, Managing Director Tarek Abulela said, adding that the rest is exported throughout the region.

($1 = 17.7100 Egyptian pounds)

Reporting by Nadine Awadalla; Editing by Matthew Mpoke Bigg

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Novartis gene therapy approval signals new cancer treatment era

(Reuters) – Novartis AG on Wednesday won highly anticipated U.S. approval for the first of a new type of potent gene-modifying immunotherapy for leukemia, a $475,000 treatment that marks the start of a potential new treatment paradigm for some cancers.

The approval was widely expected after an FDA advisory panel last month unanimously recommended the action.

Novartis shares closed virtually unchanged in Swiss trading.

Novartis also announced an agreement with the U.S. Centers for Medicare and Medicaid Services under which payment for the therapy will be based on clinical outcomes achieved.

The treatment, called Kymriah, was approved for patients up to 25 years of age who have relapsed or not helped by prior treatment for B-cell acute lymphoblastic leukemia (ALL).

Dr Kevin Curran, a pediatric oncologist at Memorial Sloan Kettering Cancer Center in New York, noted the treatment’s high cost.

“Of course, we have to talk about pricing from a national standpoint,” he said. “But if I have a parent and a (sick) child in front of me, and I have an opportunity to save them, we’re going to take that.”

Kymriah belongs to a new class of treatments called CAR-T therapies. It involves removing disease-fighting T cells from a patient, genetically modifying them to better recognize and attack cancer, and then replacing them, where they can circulate for years seeking out the disease.

Novartis estimates some 600 ALL patients a year would be eligible for Kymriah. It expects to open five treatment centers within days and 35 by year-end.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” Food and Drug Administration Commissioner Scott Gottlieb said in a statement.

The FDA said it has granted 76 applications for trials involving experimental CAR-T therapies.

Shares of Gilead Sciences Inc, which this week announced an $11.9 billion deal to buy Kite Pharma, were up 6.2 percent to $80.47 on Wednesday afternoon, as Kite is widely expected to receive the next U.S. approval of a CAR-T therapy for a different blood cancer.

Shares of Bluebird Bio Inc, which is developing a promising CAR-T treatment, were up 11.1 percent at $113.73.

“Two years ago many people would have told you these types of treatments were science fiction,” said Brad Loncar, chief executive of Loncar Investments, which runs the Loncar Cancer Immunotherapy ETF

In clinical trials, CAR-T therapies have shown remarkable efficacy against blood cancers. In the pivotal Novartis trial, 83 percent of patients achieved remission with a disease that has historically poor outcomes.

“We’ve never seen anything like this before and I believe this therapy may become the new standard of care for this patient population,” Dr Stephan Grupp of Children’s Hospital of Philadelphia said in a statement.

However, this type of therapy carries risk of severe side effects. Kymriah will have a boxed warning for cytokine release syndrome, a potentially lethal systemic response to the activation and proliferation of CAR-T cells, causing high fever and potential for neurological problems.

Shares of Juno Therapeutics Inc, which last year reported a handful of patient deaths during trials of its CAR-T therapy, were down 8.9 percent at $39.92.

Reporting by Bill Berkrot and Mike Erman in New York, Natalie Grover in Bengaluru, Deena Beasley in Los Angeles and Julie Steenhuysen in Chicago; Editing by Shounak Dasgupta and Matthew Lewis

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Women at Risk for Alzheimer’s Face Critical 10-Year Window, Study Says

News Picture: Women at Risk for Alzheimer's Face Critical 10-Year Window, Study Says

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MONDAY, Aug. 28, 2017 (HealthDay News) — Women with a genetic predisposition for Alzheimer’s disease face a 10-year window when they have far greater chances of developing the disease than men with similar genetic risks, a new analysis suggests.

That window seems to occur between ages 65 and 75 — more than 10 years after the start of menopause, say University of Southern California researchers who reviewed 27 prior studies.

“Menopause and plummeting estrogen levels, which on average begins at 51, may account for the difference,” said study co-author Judy Pa. She is an assistant professor of neurology at the USC Neuroimaging and Informatics Institute.

“However, scientists still don’t know what is responsible. Researchers need to study women 10, 15 or even 20 years before their most vulnerable period to see if there are any detectable signals to suggest increased risk for Alzheimer’s in 15 years,” Pa said in a university news release.

According to the study, “genetically vulnerable” white men and white women aged 55 to 85 have similar odds for developing the disease except during those 10 years, when the risk appears to jump for women.

But more research is needed to prove the study’s assumptions, the study authors acknowledged.

The study challenges long-held beliefs about Alzheimer’s risk. It also may have significant implications for women, since nearly two-thirds of the more than 5 million Americans now living with Alzheimer’s disease are female.

“Our discovery is important because it highlights how clinical trials could be weighted toward women — a susceptible part of the population — to help scientists more rapidly identify effective drug interventions to slow or cure Alzheimer’s,” said Arthur Toga, director of the Neuroimaging and Informatics Institute.

The analysis focused on more than 31,000 white North Americans and Europeans in the Global Alzheimer’s Association Interactive Network. All were diagnosed with Alzheimer’s between the ages of 55 and 85.

The researchers honed in on a gene variant linked to Alzheimer’s, known as ApoE4.

The researchers noted that it’s commonly assumed that women are at higher risk for Alzheimer’s because they tend to live longer than men. This is likely an oversimplification.

The researchers pointed out that higher rates of heart disease and stroke among men could mean that men who survive into older age are healthier than their female peers and at lower risk for Alzheimer’s.

The study authors suggested that some day doctors attempting to prevent the memory-robbing disease might treat men and women at different ages.

Not all women in their mid-60s or mid-70s are more likely than men to develop Alzheimer’s, however. The ApoE4 gene is a risk factor for the illness, but screening for it doesn’t provide conclusive answers about what the future will hold, the researchers cautioned.

“There is controversy in terms of whether people should know their ApoE status because it is just a risk factor,” Pa said. “It doesn’t mean you’re going to get Alzheimer’s disease.”

The researchers said larger and diverse studies that involve more women and minorities are needed to confirm their findings.

The study was published Aug. 28 in Journal of the American Medical Association Neurology.

— Mary Elizabeth Dallas

MedicalNews
Copyright © 2017 HealthDay. All rights reserved.

SOURCE: Keck School of Medicine, University of Southern California, news release, Aug. 28, 2017

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