BY THOMAS TRACY  GRAHAM RAYMAN
NEW YORK DAILY NEWS
 
Updated: Friday, April 7, 2017, 12:12 AM

Heroin needles in their arms. Prescription painkillers swallowed or crushed and snorted. And gel scraped from fentanyl patches eaten by abusers.
These are the ways a record number of New Yorkers — about 1,300 people — fatally overdosed last year. That’s more than twice the number of people who were murdered or killed in car wrecks — combined.
Officials attributed about 80% of the overdoses to opioids; out of those, 90% were caused by heroin or fentanyl, a powerful synthetic drug.
The stories of people dying to get high are as common as they are startling.
Nine people overdose in 24-hour span amid NYC's opioid epidemic
“I could recount to you story after story that would literally chill you,” Dermot Shea, the NYPD’s chief of crime control strategies, said Thursday. “Pregnant women overdosing. A couple, one is saved and an hour later we’re responding back to the same apartment for the other.”
The overall number of overdoses jumped about 39% last year from the year before. And the number of overdoses has more than doubled from two decades ago, prompting some health officials and cops to compare the opioid crisis to the crack epidemic of the ’80s and early ’90s.
The problem has gotten so bad, the NYPD has begun tracking opioid overdoses in “real time.” Every overdose report — from heroin or pain killers — is tracked in a system called RxStat — similar to the NYPD crime-tracking system CompStat — to identify “hot spots.”
Speaking at a conference attended by law-enforcement executives from across the country, Shea said 17,000 NYPD officers have been trained in the use of Narcan. The NYPD uses the nasal spray form of the drug, which blocks the effects of opioids. By June, all 23,000 or so patrol officers will be equipped with the medication.
City vows to cut overdose deaths by 35% over next 5 years
All FDNY medics are trained and equipped with the drug, a spokeswoman said.
Police officials on Thursday revealed other alarming stats:
Heroin was involved in 59% of all overdose deaths in the city in 2015, the latest data available.
About 23% of overdose deaths in 2015 were attributed to pain pills.
Two overdose on opiates at Staten Island Ferry Terminal
TO CONTINUE READING:  http://www.nydailynews.com/new-york/nyc-crime/nypd-tracks-opioid-overdoses-new-york-city-real-time-article-1.3024889

Gilead Press Release - First HCV Direct-Acting Antivirals Approved for Use in Adolescents  

‎FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved supplemental indications for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi® (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg. Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin. There are an estimated 23,000-46,000 pediatric HCV patients in the United States, most of whom were infected with the virus at birth. [More...] 
‎Gilead Notches Pediatric Use For Sovaldi, Harvoni As Sales Fade Among Adults
by Eric Sagonowsky  FiercePharma  Apr 7, 2017
Amid a tough time for the drugmaker as its hep C sales crash, Gilead scored a win on Friday as the FDA approved the company’s Sovaldi and Harvoni for pediatric patients.
Patients 12 and older with hep C genotypes 1 through 6 will be able to use Sovaldi or Harvoni to treat their disease, which is often transmitted at birth for these young patients. An estimated 23,000 to 46,000 pediatric hep C patients live in the U.S., according to Gilead’s Friday release.‎
The approvals marked a win for both patients and the Foster City, California, drugmaker, which has been struggling to keep its hep C sales engine churning in recent quarters. That has prompted a call for the company to make big M&A moves, but with its share price slumping, the company has yet to pull the trigger on any major deals.
For patients, the FDA’s Friday decision means they’ll have their first alternative to interferon injections. University of Washington School of Medicine pediatrics professor Karen Murray said in a statement the drugs “represent an important advance” for the patient group.
For Gilead, serving another patient population can’t be a bad thing. Suffering from new competition in hep C from AbbVie and Merck, the drugmaker has seen its dominance of the blockbuster market collapse over the last year, denting its revenues and share price along the way.
Gilead’s 2016 sales came in a $30.39 billion, a 7% slip from the $32.6 billion in turned in back in 2015. The Big Biotech is calling for total 2017 revenues of $22.5 billion to $24.5 billion, a 22% decline from 2016 if it hits the midpoint. 
Chiefly contributing to that pain is Gilead’s hep C sales. Harvoni revenues tumbled 34% last year versus the year prior, while Sovaldi fell 24%. Those two meds alone lost $6 billion in sales in 2016 versus 2015. Looking ahead, Gilead is predicting total 2017 hep C sales of $7.5 to $9 billion, a big decline from the $14.8 billion its products turned in last year.
With that considered, industry watchers and analysts have called on the company to make dramatic moves. Barclays analyst Geoff Meacham recently wrote an open letter to management, making his point that Gilead’s “deal parameters should evolve” given its current situation.
http://www.fiercepharma.com/regulatory/gilead-notches-sovaldi-harvoni-approvals-pediatric-patients?utm_medium=nl&utm_source=internal&mrkid=4595120&mkt_tok=eyJpIjoiWTJWa09ERTFNVGd4WlRFeCIsInQiOiJ5QzFhWkJyNFVPN3FEOHpuT29kTEFSS3hqcVVyeFwvXC9SQjZ0blcyVkFQVTV5Mk44THRGVGNWU09UU0JhRFpxcU5MUlVPZXI3enpnZ1RsSFJiUysrakRJQWZ1NFBjbHNaeWhhN2szRWp2bWRRM3ZzVUdLV1NlQ2lHZ2xDalFhWFlVIn0%3D 

Lingering Republican threats to the ACA and Medicaid do no favors for America’s working poor    
By Annette Gaudino-TAG-Treatment Action Group

The 2016 election is in large part a story of the failure of existing health policy to adequately address a health crisis among the working class. The largest voter margins in favor of Trump comprise many people in poor health. This includes the opioid overdose epidemic currently occurring among predominantly white, suburban, and rural communities battered by deindustrialization and dimmed economic prospects. Affordable Care Act (ACA) repeal and replace legislation, presently defeated with the fall of the American Health Care Act (AHCA) but still an ambition of the White House administration and Republican Congress, threatened to make a bad situation worse.
The federal government has a large role to play in funding the public health response to the ongoing opioid crisis and its sequelae, including hepatitis C virus (HCV) and HIV. The expansion of Medicaid under the ACA to cover individuals living at 138% of the federal poverty level (approximately $16,000 for an individual and $33,000 for a family) is key. Roughly half of the 22 million Americans who receive health insurance coverage under the ACA are covered under Medicaid expansion.
Medicaid is currently a federal entitlement, meaning the U.S. government is committed to at least matching state funding to guarantee coverage for all Americans meeting eligibility requirements. Wealthy states with large tax bases, such as New York, split Medicaid costs 50/50 with the federal government. States with a lower GDP and smaller tax base are in effect subsidized by federal tax dollars. For example, approximately 70% of red-state Kentucky’s costs are paid with federal funds.
In recent years, many states have moved to managed care Medicaid programs, with patient care being increasingly budgeted on a per-capita basis and delivered with per-capita costs in mind. In the best cases, this provides strong incentives towards preventive care, but managed care can also be used to limit access to expensive treatment options, as we’ve seen with restrictions to HCV curative treatments based on disease progression or sobriety.
The introduction of AHCA in early 2017 initiated the next great battle in U.S. healthcare reform. The bill, pulled from the floor of the House of Representatives after it became clear the Republican Party did not have the votes to pass the measure, maintained the most popular provisions of the ACA, while providing generous tax refunds to those who need it least and sought to end the entitlement to health care under Medicaid. Where the bill succeeded was in providing a clear view of the GOP’s political goal: relieve the federal government of the burden to fund health care for the poor.
If AHCA had passed, the proposed per-capita caps would have cut $880 billion in federal funding for all state Medicaid programs and resulted in 14 million people losing Medicaid coverage by 2026. Per-capita caps or block grants would have also left Medicaid programs with even fewer financial resources to cover exorbitantly priced curative hepatitis C treatments and comprehensive HIV care.
For the low-income individuals and families who would have been thrown into the for-profit insurance marketplace, the AHCA proposed replacing income-based premiums and subsidies with fixed age-based refundable tax credits, regardless of the actual cost of insurance where they live, which varies significantly across states. Additionally, AHCA would have allowed insurers to charge older enrollees up to five times what they charge younger ones (up from 3:1 under the ACA), effectively wiping out the value of the slightly larger tax credit for those 60 years of age and older. Those that managed to remain on Medicaid were at risk of losing essential benefits coverage, including mental health and substance use treatment—a particularly short-sighted change given the opioid epidemic. 
As was evident with AHCA, however, the road to replacing the ACA is rocky for GOP leadership. The House bill effectively alienated all stakeholders: voters would have seen their subsidies to purchase insurance cut significantly, hospitals and other providers would have faced reduced funding and more unreimbursed care, private insurers would have been left with sicker enrollees, and Congressional members ideologically committed to free market solutions would have been left wanting. The split between Republicans in Congress and in State Houses remains particularly difficult to bridge—the former don’t have to balance budgets under the additional public health burden of hundreds of thousands of potentially uninsured residents.
TO CONTINUE READING:
​http://www.treatmentactiongroup.org/content/resisting-coming-austerity-medicaid-crosshairs

​Trump’s early tough talk on drug pricing is now a pro-industry, anti-regulation GOP dreamscape
By Bryn Gay- Treatment Action Group

Unaffordable drug prices were a hot-button topic on the 2016 U.S. presidential campaign trail and remain a significant source of frustration among Democrats and Republicans in Congress. This common ground, backed by public opinion (see sidebar), can be leveraged to steer drug-pricing legislation and regulations toward truly bold initiatives that prioritize affordable treatment access.

Within his first two weeks in office, Trump met with pharmaceutical executives and regurgitated classic capitalist remedies for high drug pricing. Rather than consulting with patient groups or health policy specialists, the administration has primarily focused on meeting with the pharmaceutical industry. Trump’s initial stance of empowering the U.S. government to step up its ability to negotiate drug prices, notably for Medicare, have since shifted toward fast-tracking drug approval and rolling back regulations.
Trump’s proposals fall short of and diverge from popular demands because they lack the ambition of approaches used in other countries to rein in drug cost expenditures: consolidation of purchasing power and other initiatives that would contribute to lower prices and earlier generic competition, such as shortened patent life; increased transparency in research and development (R&D) costs and pricing; and open-source research that discloses scientific findings, deprioritizes patent protection, and avoids monopolistic pricing. Executive action on drug pricing, however, appears unlikely.
Value-based drug-pricing regulations, such as those established by Germany’s AMNOG law, are another model that could potentially guide U.S. drug pricing reform and reward scientific innovation without bankrupting payers or patients. AMNOG determines pricing decisions on the basis of independent assessment of a new drug’s additional clinical benefits over existing drugs, relies on full transparency in all negotiation steps, and negotiates directly with pharmaceutical companies and key stakeholders, rather than involving government intermediaries. However, value-based pricing raises additional significant questions. Is a market-based economic system the best way to value drugs and human lives? Is the methodology of value-based tendering in itself transparent and does it reflect patients’ concerns? Does it address true innovation, or could ‘value’ be potentially rigged by the pharmaceutical industry? 
TO CONTINUE READING:http://www.treatmentactiongroup.org/content/wrangling-affordable-drug-pricing-and-hcv-elimination-under-new-white-house-administration

​By Terry DeMio , tdemio@enquirer.comPublished 6:25 p.m. ET March 25, 2017 | Updated 9:38 a.m. ET March 27, 2017

A new cure for hepatitis C in children and adolescents is on the way, promising to help some of the silent victims of a nationwide heroin epidemic.
A Cincinnati Children's Hospital Medical Center doctor who helped lead the research for the drug combination says the new medication regiment brings hope for all children with the disease.

"Years ago, I told my patients' parents that, in your child's lifetime, we're going to have a cure for this," said Dr. William Balistreri, lead author of the study and medical director emeritus for Cincinnati Children's Pediatric Liver Care Center. Before this, he said, "there wasn't anything that was really reliable."
"This gives hope," he said.

That's exactly what it's done for Kristin "Kaylee" Ferrell, 17, of Lexington. As a child born with hepatitis C, she's been in Balistreri's care since she was about 5.
"He never gives up," she said of Balistreri, who is recognized worldwide as an expert on pediatric liver and gastroenterology disease.

Kaylee is among children who acquired the virus that attacks the liver pre-birth, from her mother, who was then addicted to drugs. Cincinnati Children's, along with other hospitals around the country, has seen a huge rise in hepatitis C in children.
Since 2009, Cincinnati Children's has seen a 450 percent rise in hepatitis C cases among children and adolescents, Balistreri said.

"Our colleagues in other centers are also witnessing this downstream effect of the surge in injection drug use," he said. About 80 percent of the kids in the study were infected by mothers who had the virus, and as for the other 20 percent, "adolescents had presumably acquired the disease from IV drug use themselves."
"We are in the midst of a massive epidemic," Balistreri said

A new cure for hepatitis C in children and adolescents is on the way, promising to help some of the silent victims of a nationwide heroin epidemic.
A Cincinnati Children's Hospital Medical Center doctor who helped lead the research for the drug combination says the new medication regiment brings hope for all children with the disease.
"Years ago, I told my patients' parents that, in your child's lifetime, we're going to have a cure for this," said Dr. William Balistreri, lead author of the study and medical director emeritus for Cincinnati Children's Pediatric Liver Care Center. Before this, he said, "there wasn't anything that was really reliable."
"This gives hope," he said.
That's exactly what it's done for Kristin "Kaylee" Ferrell, 17, of Lexington. As a child born with hepatitis C, she's been in Balistreri's care since she was about 5.
"He never gives up," she said of Balistreri, who is recognized worldwide as an expert on pediatric liver and gastroenterology disease.
Kaylee is among children who acquired the virus that attacks the liver pre-birth, from her mother, who was then addicted to drugs. Cincinnati Children's, along with other hospitals around the country, has seen a huge rise in hepatitis C in children.
Since 2009, Cincinnati Children's has seen a 450 percent rise in hepatitis C cases among children and adolescents, Balistreri said.
"Our colleagues in other centers are also witnessing this downstream effect of the surge in injection drug use," he said. About 80 percent of the kids in the study were infected by mothers who had the virus, and as for the other 20 percent, "adolescents had presumably acquired the disease from IV drug use themselves."
"We are in the midst of a massive epidemic," Balistreri said.
TO CONTINUE READING: ​http://www.cincinnati.com/story/news/2017/03/25/new-drug-breakthrough-can-cure-hep-c-kids/99485902/