New York , Aug 7(AP/UNB) — Prescriptions of the overdose-reversing drug naloxone are soaring, and experts say that could be a reason overdose deaths have stopped rising for the first time in nearly three decades.
The number of naloxone prescriptions dispensed by U.S. retail pharmacies doubled from 2017 to last year, rising from 271,000 to 557,000, health officials reported Tuesday.
The United States is in the midst of the deadliest drug overdose epidemic in its history. About 68,000 people died of overdoses last year, according to preliminary government statistics reported last month, a drop from the more than 70,000 in 2017.
"One could only hope that this extraordinary increase in prescribing of naloxone is contributing to that stabilization or even decline of the crisis," said Katherine Keyes, a Columbia University drug abuse expert.
About two-thirds of U.S. overdose deaths involve some kind of opioid, a class of drugs that includes heroin, certain prescription painkillers and illicit fentanyl. Naloxone is a medication that can reverse opioid overdoses, restoring breathing and bringing someone back to consciousness. It first went on sale in 1971 as an injection. An easier-to-use nasal spray version, Narcan, was approved in 2015.
Local, state and federal officials have embraced naloxone as a lifesaving measure. Cities and states have standing orders that allow pharmacies to give it out without a doctor's prescription, and officials have tried to put it into the hands of virtually anyone who might encounter a person overdosing, including drug users, police and even librarians.
CDC researchers noted there were fewer than 1,300 naloxone prescriptions dispensed in 2012, meaning the number grew more than 430-fold in six years.
Health officials said pharmacies should be giving out even more.
"We don't think anybody is at the level we'd like to see them," said Dr. Anne Schuchat of the Centers for Disease Control and Prevention.
The CDC report is based on data from IQVIA, a company that tracks health care information, and looked at prescriptions from more than 50,000 retail pharmacies across the country. It included both prescriptions written by doctors for specific patients and those filled under the broader standing orders.
The report offers only a partial picture, however, since only about 20% of naloxone was sold to retail pharmacies in 2017, according to an earlier government report.
Still, it's the CDC's first close look at where most retail dispensing is happening. The agency provided data for about 2,900 of the nation's 3,100 counties and parishes.
The researchers found it was most common in cities, and in the South.
Experts said the findings likely reflect a number of factors. More naloxone is likely prescribed in places where more people are using opioids and where policies increase access.
Of the 30 counties with the highest rate of naloxone dispensing in 2018, 13 were in Virginia and five were in Kentucky. But the highest naloxone dispensing rate was in Marshall County, Indiana, according to the CDC data.
The CDC recommends that naloxone be prescribed to patients who are getting high-dose opioids and are at risk for an overdose. It noted that only one naloxone prescription is written for every 69 high-dose opioid prescriptions.
Another finding: The number of high-dose opioid prescription painkillers dispensed fell to about 38 million last year, from nearly 49 million the year before.
That likely also contributed to the decline in overdose deaths last year, Schuchat said.
Kampala, Aug 3 (AP/UNB) — Researchers in Uganda have launched the largest-ever trial of the experimental Ebola vaccine that is expected to be deployed in neighboring Congo, where a deadly outbreak has killed over 1,800 people.
The trial of the Janssen Pharmaceuticals vaccine involves up to 800 people in the western district of Mbarara and is supported by Doctors without Borders and the London School of Hygiene and Tropical Medicine.
Pontiano Kaleebu, a Ugandan researcher who leads the trial, said Friday that he regrets that the Janssen vaccine has not yet been deployed in Congo. The health minister there who stepped down last month had argued against its deployment, saying a second vaccine could create confusion on the ground.
Already more than 180,000 people in Congo's yearlong outbreak have received an experimental but effective Merck vaccine, but health experts worry about the availability of doses as the virus now spreads in a major city, Goma, along the Rwanda border. The wife and 1-year-old daughter of the man who died this week of Ebola in Goma now have the disease.
Both the wife and child were doing well in treatment, Congo's new Ebola response coordinator, Jean-Jacques Muyembe, told reporters on Friday.
But he warned that about half of the cases in this outbreak are going undetected and at that rate "this epidemic could last two or three years." The current goal is to strengthen surveillance and bring the detection rate to 80%, he said.
Health experts have watched with dismay as the promise of the Merck vaccine in this outbreak has been largely overshadowed by severe challenges to virus containment efforts including rebel attacks and community resistance in a part of Congo that had never experienced Ebola before.
The Janssen vaccine has already been tested in about 6,000 people, most of them Africans, Kaleebu said. "We are excited about this (trial) ... because this is one of the promising vaccines," he said. "It's one of those vaccines that have shown a lot of promise in animal studies but also in other trials that have been conducted."
Ugandan researchers said the new trial is expected to last two years and will test how long any protection from Ebola would last. Juliet Mwanga, a co-investigator on the trial, said there is the need "to study many vaccines" in light of Congo's epidemic.
Uganda has had multiple Ebola outbreaks in the past. While it is currently free of the virus, three people died in June after crossing into the country's Kasese district on an unguarded footpath. Their family members were taken back to Congo for treatment.
The Ebola virus can spread quickly and be fatal in up to 90% of cases. Symptoms include fever, vomiting, diarrhea, muscle pain and at times internal and external bleeding. The virus is most often spread by close contact with bodily fluids of people exhibiting symptoms and with contaminated objects such as sheets. Health care workers are often at risk.
Washington, Aug 1 (AP/UNB) — The Trump administration said Wednesday it will create a way for Americans to legally and safely import lower-cost prescription drugs from Canada for the first time, reversing years of refusals by health authorities amid a public outcry over high prices for life-sustaining medications.
The move is a step toward fulfilling a 2016 campaign promise by President Donald Trump. It weakens an import ban that has stood as a symbol of the political clout of the pharmaceutical industry.
But it's unclear how soon consumers will see benefits, as the plan has to go through time-consuming regulatory approval and later could face court challenges from drugmakers. And there's no telling how Canada will react to becoming the drugstore for its much bigger neighbor, with potential consequences for policymakers and consumers there.
The U.S. drug industry is facing a crescendo of consumer complaints over prices, as well as legislation from both parties in Congress to rein in costs, not to mention proposals from the Democratic presidential contenders. Ahead of the 2020 election, Trump is feeling pressure to deliver on years of harsh rhetoric about pharmaceutical industry prices.
Making the announcement, Health and Human Services Secretary Alex Azar said the administration recognizes that prescription drug manufacturing and distribution is now international.
"The landscape and the opportunities for safe linkage between drug supply chains has changed," Azar said. "That is part of why, for the first time in HHS's history, we are open to importation. We want to see proposals from states, distributors, and pharmacies that can help accomplish our shared goal of safe prescription drugs at lower prices."
Stephen Ubl, president of the industry group Pharmaceutical Research and Manufacturers of America called the plan "far too dangerous" for American patients. "There is no way to guarantee the safety of drugs that come into the country from outside the United States' gold-standard supply chain," Ubl said in a statement. "Drugs coming through Canada could have originated from anywhere in the world."
Most patients take affordable generic drugs to manage conditions such as high blood pressure or elevated cholesterol. But polls show concern about the prices of breakthrough medications for intractable illnesses like cancer or hepatitis C infection, whose annual costs can run to $100,000 or much more. And long-available drugs like insulin have seen serial price increases that forced some people with diabetes to ration their own doses.
Azar, a former drug company executive, said U.S. patients will be able to import medications safely and effectively, with oversight from the Food and Drug Administration. Azar used to be a skeptic of importation, and was once quoted dismissing it as a gimmick.
One prong of the administration's proposal would allow states, wholesalers and pharmacists to get FDA approval to import certain medications that are also available here. Trump had recently endorsed a new Florida law to allow importation.
Another part of the plan would allow drugmakers to seek approval for re-importation of their own drugs. This second provision would cover cutting-edge biologic drugs as well mainstays like insulin, and it could apply to drugs from other countries besides Canada.
Azar said complex regulations setting up the system could take "weeks and months." He called on Congress to pass legislation that would lend its muscle to the effort, making it harder to overturn the policy in court.
"The FDA has the resources to do this," said acting FDA Commissioner Ned Sharpless. "The agency is interested in considering any reasonable proposal that maintains the bedrock of safety and efficacy for the American consumer."
Importation has backers across the political spectrum.
Sen. Chuck Grassley, R-Iowa, chairman of the panel that oversees Medicare, is a longtime supporter. He and Democratic presidential candidate Sen. Amy Klobuchar of Minnesota have a bill to facilitate importation. Sen. Lamar Alexander, R-Tenn., who chairs the health committee, welcomed the plan but said the key is whether importation can be done safely.
During Tuesday night's Democratic presidential debate , multiple candidates talked about the need to lower drug costs. Sen. Bernie Sanders, Vermont Independent, noted the disparity in U.S. and Canadian prices. "I took 15 people with diabetes from Detroit a few miles into Canada and we bought insulin for one-tenth the price being charged by the crooks who run the pharmaceutical industry in America today," he said.
The leading drug industry trade group, known as PhRMA, is a powerhouse that generally gets its way with lawmakers. It spent $128 million on lobbying in 2017, according to its most recent tax filings. But pressure on the industry is rising across many fronts.
In the Senate, Trump is supporting Grassley's bipartisan bill to cap medication costs for Medicare recipients and require drugmakers to pay rebates to the program if price hikes exceed inflation. Democrats in the House are pressing for a vote on a bill allowing Medicare to directly negotiate prices on behalf of millions of seniors. Separately, the Trump administration is pursuing a regulation that would tie what Medicare pays for drugs administered in doctors' offices to lower international prices.
Drug costs are lower in other economically advanced countries because governments take a leading role in setting prices. But in the U.S., Medicare is not permitted to negotiate.
Some experts have been skeptical of allowing imports from Canada, partly from concerns about whether Canadian suppliers have the capacity to meet the demands of the much larger U.S. market.
Backers argue that the prospect of competition will pressure U.S. drugmakers to reduce prices.
Sacramento, Jul 30 (AP/UNB) — Three pharmaceutical companies collectively are agreeing to pay California nearly $70 million to settle allegations that they delayed drugs to keep prices high, California Attorney General Xavier Becerra said Monday.
The bulk of the money will come from Teva Pharmaceutical Industries Ltd. and its affiliates for paying to delay a generic narcolepsy drug, Provigil, from entering the market for nearly six years.
Teva is paying $69 million, which Becerra says is the largest pay-for-delay settlement received by any state.
Such agreements let the developer of brand name drugs keep their monopolies over the drugs after their patents expire, thereby letting them continue to charge consumers higher prices. The drug developer pays the generic manufacturer to keep the cheaper version of the drug from entering the marketplace for an agreed period of time.
Teva said the money will come from a pre-existing fund that was created in 2015 as part of the company's settlement with the U.S. Federal Trade Commission over similar claims, and it will not make any additional payments.
Becerra said such agreements can force consumers and the health care market to pay as much as 90% more than if there were generic alternatives. More than $25 million of the settlement will go to a consumer fund for California residents who purchased Provigil, Nuvigil or Modafinil between 2006 and 2012.
"No one in America should be forced to skip or ration doses of medicine that they need ... and certainly not because a drug company is colluding to keep the price of your drug artificially high even when cheaper options could be available. But that's what's happening," Becerra said.
The second, $760,000 settlement is with Teva, Endo Pharmaceuticals and Teikoku Pharma USA over keeping a genetic alternative to the pain patch Lidoderm from entering the market for nearly two years.
Teva said it is paying $200,000 to cover the state's legal costs after settling similar federal claims earlier this year. Neither Endo nor Teikoku responded to requests for comment.
Both settlements bar the companies from pay-for-delay agreements for several years. Teva is agreeing to not to enter any such agreements for 10 years, while Endo Pharmaceuticals has an eight-year agreement and Teikoku a 20-year injunction.
Teva said the restriction is identical to its federal consent decree.
Becerra also backed pending legislation, AB824 by Democratic Assemblyman Jim Wood of Santa Rosa, that would ban such agreements.
The measure would require pharmaceutical companies to prove that their agreements are not anticompetitive. It passed the Assembly 56-0 in May and is awaiting a vote in the Senate.
Pharmaceutical companies oppose the bill, arguing the Federal Trade Commission already does this monitoring.
Dhaka, Jul 27 (UNB) - Doug Lindsay was 21 and starting his senior year at Rockhurst University, a Jesuit college in Kansas City, Missouri, when his world imploded.
After his first day of classes, the biology major collapsed at home on the dining room table, the room spinning around him, reports CNN.
It was 1999. The symptoms soon became intense and untreatable. His heart would race, he felt weak and he frequently got dizzy. Lindsay could walk only about 50 feet at a time and couldn't stand for more than a few minutes.
"Even lying on the floor didn't feel like it was low enough," he said.
The former high school track athlete had dreamed of becoming a biochemistry professor or maybe a writer for "The Simpsons."
Instead, he would spend the next 11 years mostly confined to a hospital bed in his living room in St. Louis, hamstrung by a mysterious ailment.
Doctors were baffled. Treatments didn't help. And Lindsay eventually realized that if he wanted his life back, he would have to do it himself.
Today Lindsay tells his remarkable story to audiences around the country, including at a TEDx event in St. Louis.
His journey since has amazed medical professionals.
"He did something extraordinary," said John Novack, spokesman for Inspire, a healthcare social network for rare and chronic-disease patients. When people hear Lindsay's story, Novack said, they often say, "I can do something similar for my kid."
His mother was a living prophecy
Whatever was wrong with him ran in the family.
By the time Lindsay was 18 months old, his mother was so weak she could no longer pick him up.
By the time he was 4 she could no longer walk. She did manage to pick him up one more time that year, when he was choking on a jawbreaker. She saved his life.
Otherwise, she was too frail. She lived for decades, mostly bedridden with the same condition that stole her son's twenties. After years of tests, she determined her condition was related to her thyroid, but she was too sick to travel to the Mayo Clinic to get more specialized care, Lindsay said.
Lindsay's aunt also developed the same ailment, growing so feeble she couldn't tie her own shoes.
As a teenager, watching his family members sidelined from life, Lindsay wondered whether his body was a ticking time bomb, too.
Finally, that day in 1999, the alarm went off.
"When I called my mom that night to tell her I needed to drop out (of college), we both knew," he said. The family curse had struck.
He found answers in discarded medical textbooks
From the fall of 1999 onward, Lindsay was bedridden about 22 hours a day.
"If I was up, it was because I was eating or going to the bathroom," he said.
Lindsay immersed himself in medical research, determined to find a way out. He saw specialists from endocrinology, neurology, internal medicine and other specialties. When one doctor was out of ideas, he referred Lindsay to a psychiatrist.
That's when Lindsay he realized he'd have to figure his predicament out on his own.
While in college he had picked up a 2,200-page endocrinology textbook near a garbage can, hoping to use it to figure out what condition his mom had. In it, he found an important passage discussing how adrenal disorders could mirror thyroid disorders.
By the time he was 19, Lindsay was almost completely bedridden
He zeroed in on his adrenal glands, which sit atop the kidneys on either side of the lower abdomen.
Using a stash of aging medical textbooks, Lindsay hypothesized that a whole class of autonomic nervous-system disorders could exist beyond the established categories of what most endocrinologists or neurologists knew about.
He cobbled together cash for a computer, had an old college roommate bring it over, and got to work.
Lindsay soon stumbled on the website for the National Dysautonomic Research Foundation, delighted that an entire organization was dedicated to researching the type of disorder plaguing him and his family. He asked the foundation to send him literature about emerging research in the field.
None of the diseases the foundation was examining fit Lindsay's pattern of symptoms. But he was getting closer.
He convinced a researcher who believed in him
Lindsay soon decided he needed a partner -- not just a physician but a scientist curious enough to take on a rare case and spend long hours with him parsing it out.
The best place to find that person, he reasoned, was at the American Autonomic Society's annual conference, attended by scientists from around the world who focused on nervous system disorders.
In 2002, he give a presentation about his disease at the group's meeting in Hilton Head, South Carolina. To get there, Lindsay bought a row of airline tickets so that, with the help of friends, he could lay across several seats during the flight.
At a research conference, Lindsay tried to convince specialists he had a disease that didn't appear in their textbooks
Lindsay arrived at the conference in a wheelchair, wearing a suit and tie, and presented himself as a Jesuit-trained scientist. He tried to comport himself like a grad student or a junior colleague to the scholars in the audience, not like a patient.
He was just a scientist living an experiment in his own body. During his talk, Lindsay argued that a certain drug might help him.
Several of the scientists disagreed with Lindsay's hypotheses about his ailment. But that wasn't unexpected. He didn't even have a bachelor's degree and he was telling doctors from Harvard University, the National Institutes of Health and the Cleveland Clinic something their medical training told them was impossible.
"They didn't patronize me. They treated me like a scientist," Lindsay said. "I was entering into a world of science I couldn't participate in because I was at home and couldn't be a grad student."
Dr. H. Cecil Coghlan, a medical professor at the University of Alabama-Birmingham, approached Lindsay after his presentation. Coghlan said he thought Lindsay was on to something.
At last, Lindsay had a medical ally.
His first innovation was repurposing a drug
In early 2004, one of Lindsay's friends rented an SUV, loaded a mattress in the back and drove him, lying flat, 500 miles to Birmingham.
Lindsay suspected his body was producing too much adrenaline. He knew of a drug called Levophed, which is approved by the US Food and Drug Administration to raise blood pressure in some critically ill patients. Levophed is basically an injection of noradrenaline, which counters the symptoms created by excess adrenaline.
It hadn't been done before, but Lindsay convinced Coghlan to repurpose the drug so he could live on a 24/7 noradrenaline drip for the next six years.
Lindsay spent "every second of every day" hooked up to an IV. It stabilized his condition and allowed him to be active for short periods of time around the house.
"I was no longer at risk of losing everything," Lindsay said.
Lindsay's unique case caught the eye of Dr. Cecil Coghlan, who specialized in treating dysautonomia disorders
Still, other than doctors' visits, a high school reunion and a few weddings, Lindsay's autonomic dysfunction kept him mostly confined to the house he grew up in well beyond his twenties.
Why was he so sick, he wondered? Something was dumping way too much adrenaline into his blood.
Coghlan told him he might have an adrenal tumor. But three scans of his adrenal glands all came back negative.
Discouraged but not deterred, Lindsay did the only thing he could do: He dove back into the medical literature.
And he came up with a treasure.
Later he diagnosed a disorder doctors didn't believe could exist
Lindsay suspected there might be something in his adrenal gland that acted like a tumor, but wasn't one.
A fourth scan in 2006 showed his adrenals "glowing brightly," Lindsay said, an abnormality consistent with his new theory.
Coghlan called Lindsay and said, "We found it!" The diagnosis: bilateral adrenal medullary hyperplasia.
In layman's terms, it means the medullas, or inner regions, of his adrenal glands were enlarged and acting like tumors. His adrenal glands were producing way too much adrenaline.
Experts in the field doubted the diagnosis. But Coghlan put his professional reputation on the line to back it.
As Lindsay delved into more medical literature, he found only 32 recorded cases of bilateral adrenal medullary hyperplasia.
And he fixed on what seemed like a simple solution: If he could cut out the medullas of his adrenal glands -- sort of like slicing into a hard-boiled egg and removing the yolk -- his health would improve.
Dr. Chris Bauer, Lindsay's personal physician, calls his ailment an "atypical presentation of a rare disease."
"They don't really write textbooks based on that," Bauer said. "We were were all learning with Doug as we went along."
Then he pioneered a new surgery
Lindsay finally came to a bold conclusion. "If there isn't a surgery," he decided, "I'm going to make one."
His first big lead came in 2008. He found a 1980 study from a scientist at Georgia State University, which he summed up as: "You slice the rat's adrenal gland with a razor blade and squeeze it so the medulla pops out like a pimple."
Then he found that another version of the adrenal medulla extraction had been done at Harvard. Renowned professor Walter Bradford Cannon had performed the surgery on cats in 1926. Lindsay found records of the surgery being done on dogs as well.
He built a 363-page PDF which proposed a first-ever human adrenal medullectomy.
Then he spent the next 18 months working to find a surgeon who would oversee the unorthodox procedure.
Pioneering a new surgery is a high-wire act for ethical and financial reasons as well. Surgeons could risk losing their license by performing an unproven operation, especially if complications arose. And insurance companies tend to not reimburse patients for non-standard procedures.
Because many of the doctors in that specialized field knew each other, Lindsay was careful where he pitched the idea that might save his life.
Eventually he recruited a surgeon from the University of Alabama-Birmingham. In September 2010 Lindsday went to the university hospital, where the doctor successfully extracted one of his adrenal medullas.
Three weeks after the procedure, Lindsay could sit upright for three hours. By Christmas Eve, he had the strength to walk a mile to church.
As he stood in the back of the church during midnight Mass, it finally felt like hope was winning.
But progress was slow. In 2012, he underwent a second surgery at Washington University in St. Louis to remove the medulla from his remaining adrenal gland.
A year later, he was well enough to fly with friends to the Bahamas. It was the first time in his life the Midwesterner had seen the ocean.
By early 2014, he was coming off some of his meds.
Coghlan, his champion, lived just long enough to see Lindsay's remarkable recovery. He died in 2015.
Against the odds, Lindsay had found a way to save himself.
But his mother was too delicate to be moved to another facility, let alone endure the surgery her son pioneered. She died in 2016.
She didn't get to see him walk across the stage to graduate that year from Rockhurst University with a bachelor's degree in biology, 16 years after he originally expected to begin his career.
Lindsay is now 41 years old. Many of the friends with whom he planned to graduate are now married, with kids in grade school.
In 2017 Lindsay shared his story to graduates at his alma mater, De Smet Jesuit High School in St. Louis
"You can't recapture the past," Lindsay said.
Today he still lives in his childhood home in St. Louis. He needs to take nine medications per day, and his health is far from perfect, but he has his life back.
He's not exactly the biology professor he dreamed of being at 21, but he's not far off the mark. He's leveraging his experience into a new career as a medical consultant.
"I couldn't be an assistant manager at Trader Joe's. I don't have the physical ability for that," Lindsay said. "But I can travel and give speeches and go for walks. And I can try to change the world."
Doctors are turning to him to help them identify and treat rare diseases like his own.
"I'm a full professor at Stanford, and I don't know these answers," said Dr. Lawrence Chu, who found himself leaning on Lindsay when a rare disease patient came to him. "Doug was the expert consultant."
Lindsay has spoken at medical schools, including Stanford and Harvard, and at a growing list of medical conferences. And he's working on a case study to be published in the British Medical Journal.
With his gift for solving intractable problems, he hopes to help steer other patients with hard-to-treat diseases on a path toward wholeness.
"I got help from people," he said, "and now I have to help people."