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Groups Want Painkiller Zohydro to be Revoked by FDA

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Zohydro Pill

Addiction experts, physicians and more than 40 other health care officials, are urging the Food and Drug Administration to revoke approval of the prescription drug Zohydro.

The FDA approved the medication last fall to treat chronic pain, and it is set to become available to patients in March.

The opioid drug contains a potent amount of an active ingredient that could be lethal to new patients and children and is not safer than other current pain drugs, the groups told the Food and Drug Administration.

“Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child,” they wrote in a petition to FDA Commissioner Margaret Hamburg, dated Wednesday.

“You’re talking about a drug that’s somewhere in the neighborhood of five times more potent than what we’re dealing with now,” said Dr. Stephen Anderson, a Washington emergency room physician. “I’m five times more concerned, solely based on potency.”

“In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg. “Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”

“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” added Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It will kill people as soon as it’s released.”

The same concerns are seen by the entire coalition group, mostly about the drug’s potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will increase already-rising overdose numbers.

Zohydro can contain as much as 10 times the amount of the narcotic hydrocodone as other painkillers such as AbbVie Inc’s Vicodin or UCB Inc’s Lortab, advocates said in their petition.

“Zohydro is not safer,” they wrote.

“This could be the next OxyContin,” says a petition on Change.org asking the FDA to reconsider the approval.

According to the Centers for Disease Control and Prevention, prescription opioid deaths more than quadrupled since 1999 — there were 4,030 deaths involving the drugs in 1999, compared with 16,651 in 2010.

Both Zohydro’s maker, Zogenix, and the FDA believe the drug’s benefits outweigh its risks.

“We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids,” said Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, in an e-mail to CNN. “In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.”

Anti-addiction groups push FDA to revoke approval of Zohydro

In a petition to the U.S. Food and Drug Administration, anti-addiction groups call the newly-approved drug Zohydro the next Oxycontin and they are warning if it is released to pharmacies as scheduled, it will also lead to more addiction and drug-related deaths.

FDA approves addictive opioid 10X stronger than Vicodin

The FDA just approved a controversial, highly addictive painkiller known as Zohydro. It’s 5-10 times stronger than Vicodin and retains its potency even when crushed, making it an easy target for abuse.

Related Stories:

Hydrocodone Without Acetaminophen & 10 Times Stronger Than Vicodin Being Created
Oxycodone and Hydrocodone Prescriptions On the Rise, Addiction Epidemic
Generic OxyContin Banned by FDA Until Reformulated to Help Abuse
Prescription Painkiller Deaths Across New York City Increased by 65% in 6 Years

Environmentalist. Consumer Tech Journalist. Science Explorer. And, a dreamer. I've been contributing informative news content since 2010. Follow me on all socials!

5 Comments

5 Comments

  1. Robb

    February 27, 2014 at 4:46 pm

    What about the people suffering from intractable pain? People can whine and cry about the deaths of the abusers. But, abusing is their choice. The abusers know the risk. Unless a person has had a serious injury or debilitating disease, I think it is pretty hard for them to understand just how important this pain killer is for the suffering. As far as the addicts are concerned, they are more an example of our failed mental health system. They will still be addicts with or without this pain killer. They have few options for getting off drugs and the facilities that exist are underfunded and overloaded. Don’t punish the suffering people just because you think you represent the moral high ground. You aren’t fixing anything.

    • Lisa

      March 4, 2014 at 2:47 am

      One doctor said “did our pain become so much worse in the past 20 years that we have to keep making stronger, more addicting drugs?” Well of course not! The FDA needed to get into the action of drug dealing. It’s very profitable for them! Stop fooling yourself! The governement makes more money when people become addicted. I think your attitude would change if you had someone you loved become addicted to one of the FDA’s new money makers or if your child or grandchild accidentally got into it and died. They are drug dealers and killers with a license to do so! They will kill people, they will destroy lives! They will cause more addiction, sadness and crime! By the way, it’s not really all their choice, it the pushers choice too. The FDA just gets away with being a pusher. They’ve been warned by experts and they don’t care. The only people excited about this drug are the FDA and people who are already addicted and the doctors that just keep writing prescriptions unecessarily for the money!

  2. American

    February 27, 2014 at 3:59 pm

    The Democrat nannies won’t let people who need it have it because Democrats can’t control their own drug addictions.

  3. RA Warrior

    February 27, 2014 at 3:09 pm

    This is very unfortunate that they are trying to ban this medication. It all comes down to uneducated doctors prescribing medicine to people who do not need them or lying people. When someone who is in chronic pain and absolutely miserable can not walk into their doctor’s office and obtain medication without the doctor being overly cautious it makes normal law abiding citizens lives miserable. Let the drug addicts and dealers die of this medicine because people who actually need it shouldn’t be left in pain. I can not pick up my two year old son anymore because my RA is so bad I can no longer concentrate on normal tasks and thanks to druggies I can’t get the pain relief needed. Please go die quickly and stop caring about them because I am tired of being in misery. Simple Vicodin just doesn’t cut it ūüôĀ especially when you have a disorder that makes food and medicine absorption about 10% that of a normal person.

    • guy

      February 27, 2014 at 3:55 pm

      Hydrocodone is still better than Oxycodone as far as instant addictions go. I don’t think it would bring NEW users in, so I don’t see what the big deal is. And I don’t know why these people think the FDA cares about people’s health! The only way they’d remove it, is if these groups can match the money given by the pharmaceutical industry.

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Editors' Pick

AMCA Breach: 20 Million Victims, 19 Class Actions

AMCA previously reported that there were only 200,000 victims in the recent breach, but their partner labs said there were more than 20 million. Click To Tweet

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AMCA previously reported that there were only 200,000 victims in the recent breach but the company, but their partner labs said there were more than 20 million.
AMCA previously reported that there were only 200,000 victims in the recent breach but the company, but their partner labs said there were more than 20 million. Photo: cbgrfx123 | Flickr | CC BY-SA 2.0

More than 20 million and not 200,000 have fallen victim to a massive data breach that has seen medical clients using the services of healthcare billing company, American Medical Collection Agency (AMCA), to pay for their laboratory tests in different blood testing labs across the U.S. were confirmed by the SEC filings of affected medical institutions amidst the earlier claims of AMCA that there were fewer victims.

The data breach was a result of a cyber attack that aims to phish for financial information from the website of the AMCA. The exposed data belongs to Americans who paid laboratory services at several clinical and blood testing labs and institutions and used the AMCA billing portal.

What happened in the AMCA breach?

Data that were stolen from the victims include their names, phone numbers, dates of birth, home addresses, social security numbers, credit card numbers, and other bank details. The said information was auctioned off by the hacker in several financial hacking forums.

According to DataBreaches.net, the organization who first reported about the incident, AMCA officials, following the notification of the breach confirmed that their system has been compromised and has remained undetected for more than eight months. AMCA corroborated that the breach took place between August 1, 2018, and March 30, 2019.

Notifications have been sent by several of AMCA’s corporate partners and clients to their customers following the disclosure of the security breach that has seen information from millions of Americans compromised.

Related: Hospitals Only Spend 5% Of Its Budget For Cybersecurity Amidst 82% Of Them Reporting To Have Been Attacked

The list of impacted testing laboratories includes Quest Diagnostics (11.9 million patients), LabCorp (7.7 million patients), BioReference Laboratories (Opko Health subsidiary, 422,600 patients), Carecentrix (500,000 patients), and Sunrise Laboratories (undisclosed number of patients).

However, neither the AMCA nor its five clients have yet to notify ALL impacted citizens by the breach making them vulnerable to a lot of cyber crimes and their financial data could be used by anyone who gets hold of the information against the persons of those who still don’t know that their financial information is floating around the internet.

The companies involved in the breach are facing several lawsuits

Appropriately, the lawsuit came into the direction of AMCA, Quest, and LabCorp regarding the incident. More than 11 class-suite actions have been filed against the three companies for their inability to protect consumer data. The 11 lawsuits were recorded at The United States Judicial Panel on Multidistrict Litigation (JPML) on June 3. Since then, eight more lawsuits were filed against the companies in federal courts from New Jersey, New York, and California.

According to litigation experts, “If many cases are filed in federal court, any of the lawyers on any of those cases can file a motion with the JPML [..] to centralize the various federal cases that have been filed by sending all of them to a single judge for coordinated pre-trial proceedings.”

“Healthcare companies are especially susceptible to data breaches not only because they aggregate a tremendous amount of important and sensitive data, but also because they tend to be less focused on cybersecurity protection than other industries,” said John Yanchunis of Morgan and Morgan, one of the firms who filed lawsuits against Quest Diagnostics.

“These companies, like Quest Diagnostics, know they are at an increased risk and yet have not taken the proper steps to protect their patients’ data. We will fight for justice on behalf of those impacted by this breach,” added Yanchunis.

Lawmakers are demanding an explanation

The U.S. government, led by attorneys general from Connecticut and Illinois has also opened an investigation on the matter. Furthermore, lawmakers and other politicians have sent letters to the responding companies to ask for an explanation of why an eight-month data breach remained undetected and to demand accountability from them.

In Washington, US Sen. Mark Warner (D-VA) also sent a letter to Quest Laboratories demanding the company explain its vetting process for selecting AMCA as a billing vendor, and what requirements a third-party vendor has to pass. Democratic New Jersey Sens. Cory Booker and Bob Menendez also sent letters to AMCA, Quest, and LabCorp, seeking official answers on how a breach of this severity went undetected for eight months.

“The months-long leak leaves sensitive personal and financial information vulnerable in the hands of criminal enterprises. Moreover, such breaches force victims to contend with identity theft that may lead to irreparable harm to their credit reports and financial future,” said the letter sent by the NJ senators.

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Arts & Entertainment

‘The Hunger Games’ Is Launching A Prequel And A Possible Movie

Suzanne Collins is releasing a prequel to The Hunger Games storyline and Lionsgate is already looking forward in turning it into a blockbuster movie Click To Tweet

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Source: Scholastic

Almost fours years after the last The Hunger Games movie (The Hunger Games: Mockingjay Part II) and almost nine years after the first book from the trilogy was released, Suzanne Collins is returning with the famed trilogy — but this time in a form of a prequel.

Scholastic, the publishing company that distributed Collins’ The Hunger Games trilogy, announced today that it is publishing a prequel novel to the series, currently untitled, which will hit shelves on May 19, 2020.

“Suzanne Collins is a master at combining brilliant storytelling, superb world-building, breathtaking suspense, and social commentary,” Scholastic Trade Publishing President Ellie Berger said in a statement. “We are absolutely thrilled — as both readers and publishers — to introduce the devoted fans of the series and a new audience to an entirely new perspective on this modern classic.”

Collins’ original Hunger Games trilogy—The Hunger GamesCatching Fire, and Mockingjay—altogether, sold more than 100 million copies and has been translated into more than 50 languages. Moreover, The Hunger Games books appeared on the New York Times bestseller list for more than 260 consecutive weeks (more than five straight years).

After writing the last installment in 2010, Collins teased in 2013 that she was working on a new series, but did not say whether it was related to The Hunger Games.

This time, the novel will be set in the world of Panem, 64 years before the events of the original Hunger Games trilogy—the morning where Katniss Everdeen volunteered as a tribute on the 74th Hunger Games. Presumably, Katniss Everdeen played by Jeniffer Lawrence will not be involved in the upcoming novel.

Based on the previous novels in the series, 74 years before the main novels, the 13 Districts of Panem already tried to initiate a rebellion against the Capital. In the aftermath of the failed attempt, 12 Districts remained to leave District 13 to rubbles. The Hunger Games was a result and served as a reminder that all the other Districts should obediently comply with the Capital’s rule.

The novel will take place 10 years after the first rebellion and will tell the story of Panem during the “Dark Days following a failed rebellion in Panem “With this book, I wanted to explore the state of nature, who we are, and what we perceive is required for our survival,” Collins told the Associated Press in the announcement. “The reconstruction period 10 years after the war, commonly referred to as the Dark Days — as the country of Panem struggles back to its feet — provides fertile ground for characters to grapple with these questions and thereby define their views of humanity.”

On other news, the Lionsgate film studio, who adapted The Hunger Games trilogy into movies, is already looking forward to the next addition to Collins’ franchise given that it received praise and public attention for producing them.

“As the proud home of the Hunger Games movies, we can hardly wait for Suzanne’s next book to be published,” said Joe Drake, chairman of the Lionsgate Motion Picture Group, in a recent statement to the Associated Press. “We’ve been communicating with her during the writing process and we look forward to continuing to work closely with her on the movie.”S

Lionsgate turned Collins’ Hunger Games novels into a series of four films, dividing the last novel, Hunger Games: Mockingjay, into a two-part finale. Over the course of the four movies, it earned almost $3 billion dollars an the worldwide box office with the last movie earning $653.4 million.

Collins helped with the movies as an executive producer and a co-screenwriter on the first 2012 movie but distanced herself after she finalized Mockingjay in 2010.

Lionsgate is also known to have produced Twilight, which is one of their platinum franchises along with Collins’ trilogy. The studio earlier licensed The Hunger Games to theme parks and live concert tours being built around the movie franchise.

Additionally, it starred Jenniffer Lawrence who played the main character as Katniss Everdeen in all of the four movies, which helped catapult her acting career in 2012.

Scholastic acquired world English rights to the prequel novel and it will publish in print, digital and audio formats in the US, Canada, the UK and Ireland, Australia, and New Zealand next year. The deal was negotiated by Rosemary Stimola of the Stimola Literary Studio for Suzanne Collins and David Levithan, VP, Publisher, and Editorial Director, for Scholastic.

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Editors' Pick

Global Ice Melting At Rates Faster Than Expected

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Photo by Sergey Kuznetsov on Unsplash

The global ice, or the size and number of glaciers located across cold spots around the world, is a clear indicator of the effects of global warming. With human’s excessive and consistent use of o-zone depleting resources such as fossil fuels — the rate of global ice is melting will only keep accelerating.

The National Snow and Ice Data Center reported that based on data they have gathered since the1900s, glaciers around the globe are shrinking and melting at an alarming rate.

Arctic sea ice has been in constant general low over the years following the increasing trend of greenhouse gas. Additionally, as the frozen ground across the Arctic melts, it releases a massive amount of methane, a potent greenhouse gas. Scientists say that this effect could make global ice melt accelerate even faster.

A separate study found that parts of the Canadian Arctic are experiencing a rate of permafrost thaw six times the long-term average.

Meanwhile, melted ice is especially notable both in and around Greenland — home to the second largest ice sheet on the planet.

“Communities in #Greenland rely on the sea ice for transport, hunting, and fishing. Extreme events, here flooding of the ice by abrupt onset of surface melt call for increased predictive capacity in the Arctic,” Steffen Olsen, a climate researcher at the Danish Meteorological Institute said in a tweet.

Olsen was referring to Greenland losing 2 billion metric tons of ice. “The high melt is unusual so early in the season but not unprecedented,” Greenland Ice said in a tweet.

Experts are calling the lost ice “not normal” considering that it equates to almost half of Greenland. Roughly 45 percent of the ice sheet surface has been melting. Usually, less than 10 percent of the ice sheet surface is melting at this time of year. According to data from the National Snow and Ice Data Center, Wednesday set a daily record for the widest melt area on that date, with 275,000 square miles.

“I’m losing the ability to communicate the magnitude [of change],” Jeremy Mathis, a longtime Arctic researcher and a current board director at the National Academies of Sciences told Mashable. “I’m running out of adjectives to describe the scope of change we’re seeing.”

On other parts of the globe, a city in western Alaska is experiencing drastic changes to its land formations as the state’s ice and permafrost are starting to thaw away.

“Springtime in Alaska isn’t what it used to be. This is the 3rd time past 21 years we can say” warmest spring of record.” 1998 was the warmest to date, exceeded in 2016 and now 2016 exceeded in 2019. Trend +4.0F (+2.2C) since the 1970s.” Rick Thoman said in a tweet.

The continued ice and permafrost melting in Iceland are causing significant damages in terms of requiring towns and villages like Newtok in western Alaska to relocate to avoid dangers.

“It’s a real challenge because in the US there isn’t the precedence to deal with this and there isn’t the political framework to deal with it either,” said Susan Natali, a scientist and Arctic expert at the Woods Hole Research Center in Massachusetts. “The numbers needing relocation will grow, the costs are going up and people’s lives and cultural practices will be impacted.

“Every year there’s a new temperature record, it’s getting worse and worse and you feel like a broken record saying it. This should be the number one urgent conversation happening right now because it’s not just going to be Alaska, it’s going to be other communities all over the US,” Natali added.

The problem does not only persist in Greenland, the Arctic or Alaska. Global ice is melting all across the globe. “The famed snows of Kilimanjaro have melted more than 80 percent since 1912. Glaciers in the Garhwal Himalaya in India are retreating so fast that researchers believe that most central and eastern Himalayan glaciers could virtually disappear by 2035 […] From the Arctic to Peru, from Switzerland to the equatorial glaciers of Man Jaya in Indonesia, massive ice fields, monstrous glaciers, and sea ice are disappearing, fast,” the National Geographic reported.

This week, the Pope has talked to oil executives in the Vatican to find solutions in the growing problem of global warming. He called for a “radical energy transition” from conventional fossil fuels and develop greener energy alternatives.

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