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Update June 2017


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Update June 24, 2017

FDA asks drugmaker to stop selling its opioid painkiller

(AP Photo/Andrew Harnik, File)

Linda A. Johnson

Trenton, N.J. (AP) - U.S. regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it.

The Food and Drug Administration said Thursday it has asked Endo Pharmaceuticals to stop selling its reformulated, extended-release painkiller, Opana ER, after concluding the drug’s risks outweigh its benefits.

It’s the first time the FDA has asked a drugmaker to remove an opioid painkiller from the market. The agency said it has seen a “significant shift” from people crushing and snorting Opana ER to get high to injecting it.

Endo said in a statement it’s “reviewing the request and is evaluating the full range of potential options.”

Wall Street responded quickly with a sell-off, and Endo shares plunged 13.4 percent to $11.93 in trading after U.S. markets closed.

The FDA move comes after advisers, reviewing the safety of Opana ER at a March hearing, voted 18-8 against keeping it on the market.

Besides contributing to overdoses, abuse of Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles, according to the FDA.

“We are facing an opioid epidemic - a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits.”

About 2 million Americans are addicted to prescription opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin.

Endo first got U.S. approval for its extended-release opioid, Opana ER, in 2006. It reformulated that drug in 2012 and claimed the changes made it harder to manipulate physically or chemically to abuse it. Endo tried to persuade FDA officials that the new formulation was abuse-resistant, which likely would have given the product a marketing advantage in the crowded, lucrative category of opioid painkillers.

The FDA didn’t agree, refusing to let Endo market the new formulation as abuse deterrent when it granted approval for sales several years ago.

If Endo doesn’t comply with the FDA’s request to stop selling Opana ER, the agency can hold a hearing and start a formal process for rescinding its approval.

According to the FDA, there are no generic versions of the reformulated Opana ER on the market. However, generic versions of both the original Opana ER and the original immediate-release version, called oxymorphone ER, are on sale.

Those generic products might also face action by the FDA, which said it is “assessing the latest available data on abuse patterns.”

Endo Pharmaceuticals makes generic pills and specialty drugs, which generally are expensive medicines for complex disorders. It’s part of Endo International plc, which is based in Dublin, Ireland, and has U.S. headquarters in the Philadelphia suburb of Malvern.

Endo had about $4 billion in revenue last year, only $159 million of that from Opana.


Tips for finding opioid alternatives for surgical pain

The Associated Press

Headed for surgery? Specialists say talking to your doctors ahead of time may turn up ways to control post-operative pain while minimizing use of those problematic painkillers called opioids. Among the advice:

- Ask what to expect. Patients who are overly anxious about impending pain tend to feel worse.

- Ask your surgeon or the anesthesia team if you qualify for a nerve block or other form of regional anesthesia that numbs a particular section of the body. A nerve block administered through a catheter can allow repeated doses to keep a spot numb for days.

- Ask doctors what combinations of non-opioid medications they use to attack pain, a practice called “multimodal analgesia.” Options include intravenous doses of acetaminophen or anti-inflammatories, oral anti-seizure drugs that also work on nerve pain, sedatives and injected numbing agents.

- Ask if your hospital offers a program called “enhanced recovery after surgery” that stresses a variety of pain-control and other techniques to get patients eating, drinking and on their feet sooner so they feel better faster.

- If you’re being prescribed opioids to take home after surgery, ask how many you really need and what to do with any leftovers so they’re not misused. Some hospitals allow sending home only a few days’ supply.

- If you’ve had trouble with any type of substance abuse in the past, be frank with your doctors. They may bring in a pain or addiction specialist to help craft a customized pain-control plan.


Update June 17, 2017

Marijuana extract helps some kids with epilepsy, study says

According to a study published Wednesday by the New England Journal of Medicine, GW Pharmaceuticals’ Epidiolex, a medicine made from marijuana, but without TCH, cut seizures in kids with a severe form of epilepsy, which strengthens the case for more research into pot’s possible health benefits. (AP Photo/Kathy Young)

Marilynn Marchione

A medicine made from marijuana, without the stuff that gives a high, cut seizures in kids with a severe form of epilepsy in a study that strengthens the case for more research into pot’s possible health benefits.

“This is the first solid, rigorously obtained scientific data” that a marijuana compound is safe and effective for this problem, said one study leader, Dr. Orrin Devinsky of NYU Langone Medical Center.

He said research into promising medical uses has been hampered by requiring scientists to get special licenses, plus legal constraints and false notions of how risky marijuana is.

“Opiates kill over 30,000 Americans a year, alcohol kills over 80,000 a year. And marijuana, as best we know, probably kills less than 50 people a year,” Devinsky said.

The study was published Wednesday by the New England Journal of Medicine.

For years, desperate patients and parents have argued for more research and wider access to marijuana, with only anecdotal stories and small, flawed studies on their side. The new study is the first large, rigorous test - one group got the drug, another got a dummy version, and neither patients, parents nor doctors knew who took what until the study ended.

It tested a liquid form of cannabidiol, one of marijuana’s more than 100 ingredients, called Epidiolex (eh’-pih-DYE’-uh-lehx). It doesn’t contain THC, the hallucinogenic ingredient, and is not sold anywhere yet, although its maker, GW Pharmaceuticals of London, is seeking U.S. Food and Drug Administration approval.

The company paid for, designed and helped run the study, and another doctor involved in the study has related patents.

Patients in the study have Dravet (drah-VAY) syndrome, a type of epilepsy usually caused by a faulty gene. It starts in infancy and causes frequent seizures, some so long-lasting they require emergency care and can be fatal. Kids develop poorly, and their mental impairment seems related to the frequency of seizures - from 4 to as many as 1,717 a month in this study.

Allison Hendershot’s 12-year-old daughter Molly was four months old when she had her first. It lasted an hour and a half, and emergency room doctors medically induced a coma to stop it. Molly, who lives in Rochester, New York, has tried more than half a dozen medicines and a special diet, but her seizures continued.

“We literally could not count how many” before she started in the study, her mom said.

It included 120 children and teens, ages 2 to 18, in the U.S. and Europe. They took about a teaspoon of a sweet-smelling oil twice a day (drug or placebo) plus their usual anti-seizure medicines for 14 weeks. Their symptoms were compared to the previous four weeks.

Serious seizures with convulsions dropped from around 12 a month to about six for those on the drug and did not change in the others. Three patients on the drug became seizure-free during the study.

It’s no panacea, though. Diarrhea, vomiting, fatigue, sleep problems and other issues were more frequent in the drug group. Twelve patients quit the study - nine on the drug and three in the placebo group.

Hendershot thinks her daughter got the dummy medicine because they saw no change in her seizures until the study ended and all participants were allowed to try the drug.

By the second day they saw a difference, and “she went seizure-free for two months. It was pretty remarkable,” Hendershot said.

The fact the drug came from marijuana “did not matter to me at all,” she said. “If it helps, we’re happy. I think people hear ‘cannabis’ or that it comes from marijuana and immediately there’s a stigma attached to it.”

For those who swear marijuana helped them, “anecdote has been confirmed by data,” Dr. Samuel Berkovic writes in a commentary in the medical journal. He is an epilepsy researcher at the University of Melbourne in Australia, where medical marijuana was legalized last year, and has worked with Devinsky in the past.

The drug is being tested in a second large study in kids with Dravet syndrome, and in studies of some other types of epilepsy. (AP)


Update June 10, 2017

Science Says: What’s known and not known about marijuana

This April 15, 2017 file photo shows marijuana plants on display at a medical marijuana provider in downtown Los Angeles. A new study released on Wednesday, May 24, 2017 about using a marijuana ingredient to treat epilepsy joins a limited record of scientific knowledge about the harms and benefits of pot. Experts have called for a national effort to learn more about pot and its chemical cousins. (AP Photo/Richard Vogel)

Malcolm Ritter

New York (AP) - A new marijuana study joins a limited record of scientific knowledge about the harms and benefits of pot.

The research published Wednesday is the first rigorous test of a marijuana compound in treating a certain form of severe epilepsy. It found that an ingredient of marijuana - one that doesn’t give pot smokers a high - reduced the number of seizures in children.

In the U.S., more than two dozen states allow medical use of marijuana. Federal drug regulators have not approved marijuana itself, but they have allowed man-made, chemically related medicines to treat loss of appetite in people with AIDS, and nausea and vomiting caused by cancer therapy. A marijuana extract is sold in Britain for nerve pain and other problems from multiple sclerosis.

In January, a U.S. advisory committee concluded that the lack of scientific information about marijuana and its chemical cousins, called cannabinoids, poses a risk to public health. The experts called for a national effort to learn more.

In a report from the National Academies of Sciences, Engineering and Medicine, they also rounded up what is known. Here are some of its conclusions.

There’s strong evidence that marijuana or cannabinoids:

- Can treat chronic pain in adults

- Can ease nausea and vomiting from chemotherapy

- Can treat muscle stiffness and spasms in multiple sclerosis as measured by what patients say, but less strong evidence if the changes are measured by doctors

On the other hand, it also found that pot smoking may be linked to:

- Risk of developing schizophrenia and other causes of psychosis, with the highest risk among the most frequent users

- Risk of a traffic accident

- More frequent chronic bronchitis episodes from long-term use

- Lower birthweight in offspring of female users

There’s some evidence that pot or cannabinoids may:

- Improve short-term sleep in people with some medical conditions

- Boost appetite and ease weight loss in people with HIV or AIDS

- Ease symptoms of post-traumatic stress disorder and improve outcomes after traumatic brain injury

Similarly, some evidence suggests pot use may be linked to:

- Triggering a heart attack

- An increased risk of developing a lung condition called chronic obstructive pulmonary disease

- Pregnancy complications when used by the mother

- Impaired school achievement and outcomes

- Increased suicidal thoughts and suicide attempts, especially among heavier users

- Risk of developing bipolar disorder, especially among regular users.

There’s not enough evidence to know if marijuana or cannabinoids can:

-Treat cancer

- Ease symptoms of irritable bowel syndrome

- Help with movement problems associated with Parkinson’s disease

- Improve mental health outcomes in people with schizophrenia

Similarly, there’s not enough evidence to know if marijuana is linked to:

- Increased risk of heart attacks over time from chronic use

- Development of post-traumatic stress disorder

- Changes in the course or symptoms of depression disorders

- Development or worsening of asthma

- Accidents or injuries on the job


Report: More Americans with Alzheimer’s are dying at home

Mike Stobbe

New York (AP) - One in 4 Alzheimer’s deaths in the United States is now occurring at home - a startling increase that marks a shift away from hospitals and nursing homes, according to a report released Thursday.

Alzheimer’s deaths in hospitals and nursing homes or other long-term care facilities shrank from more than 80 percent to 60 percent over 15 years. Meanwhile, those dying at home rose from 14 percent to 25 percent, the Centers for Disease Control and Prevention found.

Alzheimer’s disease is a progressive brain disorder that impairs memory, judgment and other mental abilities. It’s most common in the elderly. In the final stages of the disease, people have trouble eating and carrying on a conversation, are vulnerable to pneumonia and infections, and often need around-the-clock care.

The Alzheimer’s death rate has risen nearly 80 percent since 1999 and the disease is the nation’s sixth leading cause of death.

Deaths have been climbing for some time. A big reason is declines in other causes of death - particularly heart disease and cancer - are enabling more people to live long enough to die from Alzheimer’s, experts say.

In the new report, the CDC analyzed death certificates from 1999 to 2014 and found a surprise - a shift in where people with Alzheimer’s are dying.

Experts said it’s not clear why more people with Alzheimer’s are dying at home than in hospitals or nursing homes.

One possible explanation is patient preference. For people losing their memories, it can be a comfort to remain in familiar surroundings, said Jeff Huber, president of Home Instead Senior Care, an Omaha-based company that provides home care to tens of thousands of clients with Alzheimer’s and dementia.

But it can be difficult for families. Even if they have the insurance or money to get home-care workers to help, caring for an Alzheimer’s patient can take an exhausting toll, experts said.

As baby boomers age, “the numbers dying from Alzheimer’s are just going to get worse,” said Keith Fargo, director of scientific programs for the Alzheimer’s Association.

The CDC also released Alzheimer’s death rates for counties.

The counties with the highest rates over 10 years were tiny Eddy County in east central North Dakota, and Hamlin County in eastern South Dakota. Several counties in the South were near the top of the list.

It’s not clear why. Doctors in some places might be better at diagnosing Alzheimer’s, or coroners and medical examiners might more commonly put Alzheimer’s on death certificates instead of other causes, said Christopher Taylor, a CDC epidemiologist who was the report’s lead author.


Update June 3, 2017

Research shows aggressive treatment of sepsis can save lives

Lauran Neergaard

Washington (AP) - Minutes matter when it comes to treating sepsis, the killer condition that most people probably have never heard of, and new research shows it’s time they learn.

Sepsis is the body’s out-of-control reaction to an infection. By the time patients realize they’re in trouble, their organs could be shutting down.

New York became the first state to require that hospitals follow aggressive steps when they suspect sepsis is brewing. Researchers examined patients treated there in the past two years and reported Sunday that faster care really is better.

Every additional hour it takes to give antibiotics and perform other key steps increases the odds of death by 4 percent, according to the study reported at an American Thoracic Society meeting and in the New England Journal of Medicine.

That’s not just news for doctors or for other states considering similar rules. Patients also have to reach the hospital in time.

“Know when to ask for help,” said Dr. Christopher Seymour, a critical care specialist at the University of Pittsburgh School of Medicine who led the study. “If they’re not aware of sepsis or know they need help, we can’t save lives.”

The U.S. Centers for Disease Control and Prevention last year began a major campaign to teach people that while sepsis starts with vague symptoms, it’s a medical emergency.

To make sure the doctor doesn’t overlook the possibility, “Ask, ‘Could this be sepsis?’” advised the CDC’s Dr. Lauren Epstein.

Sepsis is more than an infection

Once misleadingly called blood poisoning or a bloodstream infection, sepsis occurs when the body goes into overdrive while fighting an infection, injuring its own tissue. The cascade of inflammation and other damage can lead to shock, amputations, organ failure or death.

It strikes more than 1.5 million people in the United States a year and kills more than 250,000.

Even a minor infection can be the trigger. A recent CDC study found nearly 80 percent of sepsis cases began outside of the hospital, not in patients already hospitalized because they were super-sick or recovering from surgery.

There’s no single symptom

In addition to symptoms of infection, worrisome signs can include shivering, a fever or feeling very cold; clammy or sweaty skin; confusion or disorientation; a rapid heartbeat or pulse; confusion or disorientation; shortness of breath; or simply extreme pain or discomfort.

If you think you have an infection that’s getting worse, seek care immediately, Epstein said.

What’s the
recommended care?

Doctors have long known that rapidly treating sepsis is important. But there’s been debate over how fast. New York mandated in 2013 that hospitals follow “protocols,” or checklists, of certain steps within three hours, including performing a blood test for infection, checking blood levels of a sepsis marker called lactate, and beginning antibiotics.

Do the steps make a difference? Seymour’s team examined records of nearly 50,000 patients treated at New York hospitals over two years. About 8 in 10 hospitals met the three-hour deadline; some got them done in about an hour. Having those three main steps performed faster was better - a finding that families could use in asking what care a loved one is receiving for suspected sepsis.

Who’s at risk?

Sepsis is most common among people 65 and older, babies, and people with chronic health problems.

But even healthy people can get sepsis, even from minor infections. New York’s rules, known as “Rory’s Regulations,” were enacted after the death of a healthy 12-year-old, Rory Staunton, whose sepsis stemmed from an infected scrape and was initially dismissed by one hospital as a virus.

What’s next?

Illinois last year enacted a similar sepsis mandate. Hospitals in other states, including Ohio and Wisconsin, have formed sepsis care collaborations. Nationally, hospitals are supposed to report to Medicare certain sepsis care steps. In New York, Rory’s parents set up a foundation to push for standard sepsis care in all states.

“Every family or loved one who goes into a hospital, no matter what state, needs to know it’s not the luck of the draw” whether they’ll receive evidence-based care, said Rory’s father, Ciaran Staunton.
 


DAILY UPDATEE

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HEADLINES [click on headline to view story]

FDA asks drugmaker to stop selling its opioid painkiller

Tips for finding opioid alternatives for surgical pain


Marijuana extract helps some kids with epilepsy, study says


Science Says: What’s known and not known about marijuana

Report: More Americans with Alzheimer’s are dying at home


Research shows aggressive treatment of sepsis can save lives


 



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