Monday, February 20, 2017

When Retirement Comes With a Daily Dose of Cannabis

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Ruth Brunn, 98, taking her medicinal marijuana with vitamin water at the Hebrew Home at Riverdale in New York City earlier this month. CreditYana Paskova for The New York Times
Ruth Brunn finally said yes to marijuana. She is 98.
She pops a green pill filled with cannabis oil into her mouth with a sip of vitamin water. Then Ms. Brunn, who has neuropathy, settles back in her wheelchair and waits for the jabbing pain in her shoulders, arms and hands to ebb.
“I don’t feel high or stoned,” she said. “All I know is I feel better when I take this.”
Ms. Brunn will soon have company. The nursing home in New York City where she lives, the Hebrew Home at Riverdale, is taking the unusual step of helping its residents use medical marijuana under a new program to treat various illnesses with an alternative to prescription drugs. While the staff will not store or administer pot, residents are allowed to buy it from a dispensary, keep it in locked boxes in their rooms and take it on their own.
From retirement communities to nursing homes, older Americans are increasingly turning to marijuana for relief from aches and pains. Many have embraced it as an alternative to powerful drugs like morphine, saying that marijuana is less addictive, with fewer side effects.
For some people, it is a last resort when nothing else helps.
Marijuana, which is banned by federal law, has been approved for medical use in 29 states, including New York, and the District of Columbia. Accumulating scientific evidence has shown its effectiveness in treating certain medical conditions. Among them: neuropathic pain, severe muscle spasms associated with multiple sclerosis, unintentional weight loss, and vomiting and nausea from chemotherapy. There have also been reports that pot has helped people with Alzheimer’s disease and other types of dementia as well as Parkinson’s disease.
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Across the nation, the number of marijuana users who are in their later years is still relatively limited, but the increase has been significant, especially among those 65 and older, according to recent studies.
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Marcia Dunetz, 80, said that she worried at first about what people would think. “It’s got a stigma,” she said. “People don’t really believe you’re not really getting high if you take it.”CreditPhotographs by Yana Paskova for The New York Times
“It’s a bigger issue than we thought,” said Brian Kaskie, a professor of health policy at the University of Iowa who co-wrote a study published in January, “The Increasing Use of Cannabis Among Older Americans: A Public Health Crisis or Viable Policy Alternative?” “This is an elephant we’re just starting to get our hands on.”
A medical marijuana education and support club started by residents of Rossmoor Walnut Creek, a retirement community east of San Francisco, has grown to 530 members — so many that it has changed meeting rooms three times.
“I would be in a lot worse shape if I wasn’t using cannabis, both physically and mentally,” said Anita Mataraso, 72, a grandmother of six who is the program director and takes marijuana daily for arthritis and nerve pain, among other ailments.
In the state of Washington, at least a dozen assisted living facilities have formal medical marijuana policies in response to demands from their residents, said Robin Dale, the executive director of the Washington Health Care Association. The association, an industry group, has posted a sample medical marijuana policy on its website.
In March, an influential group of medical providers, AMDA — The Society for Post-Acute and Long-Term Care Medicine, will tackle the issue at its annual conference. Cari Levy, the group’s vice president, will offer a “Marijuana 101” lesson on the benefits, the risks and the potential pitfalls for providers.
“People are using it, and we need know how to respond,” she said.
But as older people come to represent an emerging frontier in the use of marijuana for medical purposes, questions are being raised about safety and accessibility. Even in states where medical marijuana is legal, older people who stand to benefit often cannot get it. Most nursing homes do not openly sanction its use, and many doctors are reluctant to endorse pot use, saying not enough is known about the risks in the oldest age groups.
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The president and chief executive of RiverSpring Health, Daniel Reingold. He said he administered marijuana to his father as a painkiller shortly before his death.
CreditYana Paskova for The New York Times
“This is a target demographic that may have their access limited, if not cut off altogether, simply because they reside in a facility,” said Paul Armentano, deputy director of NORML, a group that advocates the legalization of marijuana. “It is a problem that may infringe on their quality of life.”
While there is no shortage of research on marijuana, relatively little of it has focused explicitly on older users even as their numbers grow — and not just in the United States. In Israel, for instance, older people have been treated with medical marijuana for years. And Americans for Safe Access, an advocacy group, helped open a research center in the Czech Republic that is evaluating its impact on older people.
“It’s an area that’s very important to look at,” said Dr. Igor Grant, the director of the Center for Medicinal Cannabis Research at the University of California, San Diego, adding that older people are now one of the center’s research priorities.
“Older people can be more sensitive to medicine,” he said. “It’s possible a dose safe for a 40-year-old may not be in an 80-year-old.”
Dr. Thomas Strouse, a psychiatrist and palliative care doctor at the University of California, Los Angeles, said that just as sleeping and pain medications could harm older people, marijuana could possibly make them confused, dizzy or more likely to fall.
“There is no evidence that it is particularly helpful to older people, and some reason that it could be harmful,” he said.
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Medical marijuana is kept in a safe in Marcia Dunetz’s room at the Hebrew Home at Riverdale.CreditYana Paskova for The New York Times
Most nursing homes have also taken a cautious position, often resorting to a “don’t ask, don’t tell” approach.
“If residents are taking it, they are taking it undercover without the staff knowing so it’s not part of their care plan,” said Dr. Cheryl Phillips, senior vice president for public policy and health services for LeadingAge, an industry group representing more than 2,000 nursing homes. “I think that creates a safety problem.”
Fred Miles, a Colorado lawyer who represents nursing home operators, said nursing homes — unlike assisted living facilities — were regulated by the federal government, and were fearful of jeopardizing their Medicare and Medicaid funding. Staff members who administer marijuana could also theoretically face criminal prosecution under federal law, he said, though he has never heard of that happening.
The federal Centers for Medicare and Medicaid Services said no nursing home had specifically lost financing or been penalized for permitting the use of marijuana. In New York State, which started a medical marijuana program in 2016, its use is restricted to people with designated medical conditions, including neuropathy, epilepsy, multiple sclerosis, Parkinson’s, H.I.V., AIDS and cancer.
At the Hebrew Home in the Bronx, the medical marijuana program was years in the making. Daniel Reingold, the president and chief executive of RiverSpring Health, which operates the home, said he saw its powers firsthand when his own father, Jacob, was dying from cancer in 1999. To ease his father’s pain, Mr. Reingold boiled marijuana into a murky brown tea. His father loved it, and was soon laughing and eating again.
“The only relief he got in those last two weeks was the tea,” Mr. Reingold said.
When Mr. Reingold requested approval from the nursing home’s board members, there were no objections or concerns, he said. Instead, they joked that they would have to increase the food budget.
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Hillary Peckham, of the medical marijuana dispensary Etain Health, showing an array of marijuana tincture, capsules and vaporizer cartridges. CreditYana Paskova for The New York Times
Then Dr. Zachary Palace, the medical director, developed a program that seeks to offer marijuana as an option but also comply with federal regulations: Though the nursing home recommends and monitors its use, residents are responsible for buying, storing and administering it themselves.
Last fall, the first three residents started taking marijuana pills. Their families obtain the pills at a dispensary in Yonkers run by Etain, a company licensed by the state to sell medical marijuana to qualifying patients or their designated caregivers, who must live in New York. Dr. Palace said that as the program expanded this month, as many as 50 residents could be using marijuana.
Marcia Dunetz, 80, a retired art teacher who has Parkinson’s, said she worried at first about what people would think. “It’s got a stigma,” she said. “People don’t really believe you’re not really getting high if you take it.”
But she decided to try it anyway. Now, she no longer wakes up with headaches and feels less dizzy and nauseated. Her legs also do not freeze up as often.
For Ms. Brunn, the marijuana pills have worked so well that she has cut back on her other pain medication, morphine.
Her daughter, Faith Holman, 61, said the pills cost $240 a month, which is not covered by health insurance. Ms. Holman, who lives in New Jersey, also has to ask a family friend to go to the Yonkers dispensary.
“Obstacles had to be overcome,” Ms. Holman said. “But I think she was meant to have it because everything has worked out.”
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Sen. Grassley Launches Inquiry Into Orphan Drug Law's Effect On Prices

HEALTH INC.


Senate Judiciary Committee Chairman Chuck Grassley, R-Iowa, is looking into how the Orphan Drug Act may be affecting a wide range of drug prices.
Andrew Harnik/AP
Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, has opened an inquiry into potential abuses of the Orphan Drug Act that may have contributed to high prices on commonly used drugs.
In a statement, Grassley said the inquiry is "based on reporting from Kaiser Health News" and strong consumer concern about high drug prices.
"My staff is meeting with interested groups and other Senate staff to get their views on the extent of the problem and how we might fix it," Grassley wrote.
A six-month Kaiser Health News investigation published in January found that the orphan drug program intended to help desperate patients is being manipulated by drugmakers. While the companies aren't breaking the law, they are using the Orphan Drug Act to secure lucrative incentives and gain monopoly control of rare disease markets where drugs often command astronomical price tags.
KHN's investigation, which was published and aired by NPR, found that many drugs that now have orphan status aren't entirely new. More than 70 were drugs first approved by the Food and Drug Administration for mass market use. Those include cholesterol blockbuster Crestor, Abilify for psychiatric disorders and rheumatoid arthritis drug Humira, the best-selling drug in the world.
Others are drugs that have received multiple exclusivity periods for two or more rare conditions. About 80 drugs fall into this latter category, including cancer drug Gleevec and wrinkle-fighting drug Botox.
Before the Orphan Drug Act passed, drugs for rare diseases were often abandoned during development, hence the name orphan. The patient populations were simply too small for the drugs to be financially viable for companies, they said.
Grassley, the senior senator from Iowa, is well positioned to call for changes in the law's incentives. The Judiciary Committee he oversees has jurisdiction over anticompetitive and patent-related issues. Grassley made headlines late last year calling for hearings to demand that drugmaker Mylan justify its price hikes for the lifesaving EpiPen.
Grassley's office has reached out to staff members of the Senate Health, Education, Labor and Pensions committee, which has jurisdiction over the FDA. When asked this week about a possible update to the law, the committee lauded the Orphan Drug Act for helping millions of families and said it "will continue oversight of the law to ensure it is working as intended."
But there are questions over whether the law is working as intended. Dr. Robert Califf, who left his post last month as commissioner of the FDA, said it's time to review the orphan drug program and the incentives offered to corporations.
While the law has been very successful in bringing effective treatments to patients with rare disease, Califf said, it's also the case that when a program "reaches a mature phase it's important to reassess it."
Califf went on to say, "It's understandable that whenever you put a financial incentive in place in the United States, people will try to figure out how to take advantage of it — almost all of them within the law. So, I'm not talking about illegal activity but ... there is a game of cat and mouse that goes on."
Government incentives for orphan drug development are needed because the research involved is costly, risky and uncertain, Anne Pritchett, vice president of policy and research at PhRMA, the drug industry's lobbying group, said in an interview in late 2016. This week, a PhRMA spokeswoman said the group hadn't heard of any movement on changing or updating the Orphan Drug Act.
Dr. Martin Makary, a professor at Johns Hopkins University School of Medicine and a vocal critic of the high prices of orphan drugs, has suggested that drugmakers should repay some of the federal incentive money once a drug reaches a $1 billion in annual sales.
Former U.S. Rep. Henry Waxman, D-Calif., who pioneered the Orphan Drug Act in the 1980s, thinks Congress should tackle prescription drug pricing on a variety of fronts, and that an update to the Orphan Drug Act should be part of the solution.
But Peter Saltonstall, president of the National Organization for Rare Disorders, said his group has heard "no energy" for changing the law now.
"I think the Orphan Drug Act, at least from our perspective, has been successful," Saltonstall said, adding that there are other drug pricing concerns that could be addressed by Congress.
Today, more than 450 orphan drugs have been approved. Obtaining orphan designation for a product is a popular business strategy for manufacturers. Drugs approved to treat rare diseases made up 40 percent of new drugs approved by the FDA in 2016 and nearly 50 percent of new drugs approved in 2015. The drugs are also expensive, at $111,820 for a year's treatment with an orphan drug, on average, in 2014 compared with $23,331 for a mass market drug.