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FDA Approves 2.1M Dollar Medicine, The Most Expensive Drug In History

Novartis developed a drug that cost a shocking $2.1m that aims to treat a disease that destroys a baby's muscle control. Click To Tweet

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Novartis 2.1m Drug
Photo: Corona Mejora Tu Vida CORONA | Flickr | CC BY 2.0

In 2016, the world was bombarded with news coming from the FDA that a particular muscle condition found in babies had no cure. Families began to lose hope — as more and more babies die each year. But the FDA, after making such an announcement, forgets one thing; nothing is impossible with technology.

Today, the FDA shocked the world as it approves the most expensive medicine ever created in history, which can topple down the same rare condition that destroys a baby’s muscle control years ago. The said disease kills nearly all of those affected within a couple of years.

The medicine developed by the Swiss drugmaker, also known as Novartis, can be sold at a sum of 2.125 million dollars. However, out-of-pocket costs for patients will vary based on the type of insurance they have and its coverage.

The Food and Drug Administration on Friday approved the treatment called Zolgensma, which specializes for children under age two who are confirmed having any four types of the said disease through genetic testing. The therapy includes a one-time infusion, which takes about an hour long.

FDA explained that the medicine is a gene therapy that treats an inherited condition called spinal muscular atrophy. Medical Express indicated that the treatment focuses on a defective gene that weakens a child’s muscle, which resulted in immovability, and if uncured, leads to an inability to swallow or breathe.

So, why did Novartis took time and effort to produce a drug, knowing that it costs more than half of the price of a house?

Records show that spinal muscular atrophy in the most common type, which is also the most severe, at least 90 percent of patients die by age 2 and the lucky ones who are still alive need a ventilator to breathe. Children experiencing less–severe types become disabled eventually and can live up to a couple of decades. Medical Express also revealed that every year, about 400 babies in the U.S are born with this condition.

The defective gene, which causes spinal muscular atrophy, prevents the body from making enough protein that allows nerves which control movement to work typically. The specific nerves die off without the protein. While the number continues to increase since 2016 and alarm families, Novartis studied the said disease carefully. The company saw the need to create a drug that will provide a solution to the families affected by the disease.

After three years, it brought the world the first ever drug that can change the lives of millions of babies, while making a considerable profit.

How does Zolgensma work wonders?

The drug supplies an excellent copy of the faulty gene — which allows nerve cells to start producing the needed protein. This medicine will halt the deterioration of the nerve cells and will enable the baby to develop more normally. Inpatient testing, babies with the most severe form of the disease who took Zolgensma within six months of birth, had limited muscle problems, and others who were given the treatment also performed best.

Although many families, especially those who are affected with the disease, protested on the amount of money they would spend in just one infusion, Novartis promised that the company is creating a solution to cater the less privileged ones. It will let insurers make payments over five years, meaning, a sum of only 425,000 dollars will be paid per year. However, if the treatment doesn’t work; the company will give partial rebates.

Meanwhile, in the United States, the same medicine for the disease that was also approved is called Spinraza. But unlike Zolgensma, this drug must be given every four months. The maker is known as Biogen, which charges a price of 750,000 dollars for the first year and 350,000 dollars a year after. Just like the latter, it also resorted to installments to cater to families with low income.

The day after Zolgensma was approved; it created a spur of disbelief from the public. They questioned as to why this drug costs so much. FDA and independent non-profit groups are positive enough that these drugs will create miracles in the future.

Even the Institute for Clinical and Economic Review, which rates the value of expensive new medicines, calculated that the price of the new gene therapy is justifiable at the cost of 1.2 to 2.1 million dollars because it “dramatically transforms the lives of families affected by this devastating disease.”

The FDA, on a conference, did not indicate how long the benefit of the treatment lasts, but medical practitioners’ hope that it would last a lifetime. As with the side effects, the FDA said that patients would be experiencing vomiting and potential liver damage — so they must be monitored for the first few months after treatment.

I've been contributing news since 2010, both online and print. Aside from Z6Mag, I manage independent news blogs that provide awareness on a diverse list of topics to every reader.

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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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‘Beyond Meat’ Is Introducing Ground Beef In Its Product Line

Beyond Meat is launching a plant-based ground beef alternative that tastes and cooks like your regular pound of ground beef Click To Tweet

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Source: Beyond Meat

Beyond Meat is launching a new product in its line of vegetarian-friendly meat alternatives, a one-pound package of ground beef meant to target America’s biggest seller in the meat department.

Beyond Meat is a Los Angeles-based producer of plant-based meat substitutes founded in 2009 by Ethan Brown. The company aims to supply people’s needs to consume conventional meat with healthier alternatives that are derived from plants. The company’s products became available across the United States in 2013. In May 2016, it released the first plant-based burger to be sold in the meat section of grocery stores, on an international basis

Ground beef will be Beyond Meat’s line of plant-based meat like burger patties and sausages. Recently, Beyond Meat pulled out its chicken strips for improvement. The plant-based ground beef will be called Beyond Beef and will be available in stores nationwide.

The “meat” is made from a blend of pea, mung bean, and rice proteins, and contains 25 percent less saturated fat than real beef. Aso, Beyond Beef has 20 grams of protein per four-ounce serving with a “fibrous texture” similar to beef. The company also claims that the plant-based ground beef is “versatile enough to be used in any ground beef recipe” and can be used to make your usual meatballs or for toppings in your tacos.

Beyond Beef will be offered at the Whole Foods Market in Boulder, Co., where the first Beyond Meat product was first sold at a grocery store.

“We wanted to get back to our roots and show our appreciation to the place where it all began with a little sneak preview,” the company wrote on Instagram. “…Come be among the first to try this delicious new product that delivers the versatility, meaty texture and juiciness of ground beef with less of the baggage!”

Beyond Meat’s announcement of Beyond Beef comes after the company admitting that it is still working on improving its recipe in terms of appearance, aroma, texture, and taste. The improvements are said to make their products resemble real meat better.

“It’s challenging because we aren’t satisfied with our current products. And so as much as I love to hear and to really do that you know you’ve gone out to buy the product. Part of me cringes because I know that I have a product here that’s so much better than that,” Brown tells The Verge. “We are on this mission to build a perfect piece of meat and that product is imperfect. There are things about it that aren’t exactly like meat and that really bothers us.”

Particularly, Beyond Meat’s original plant-based burger patty now has a meatier taste and texture with marbling that ‘melts and tenderizes like beef.’ The company says that they used coconut oil and cocoa butter to mimic the marbling effect.

Additionally, Beyond Meat is making their patties with more ‘neutral flavor and aroma’, and is a complete protein source from its blend of pea, mung bean, and rice proteins. It remains to be free from GMO, soy, and gluten.

“We believe in a better Beyond. A Beyond that’s always striving for more. That’s, why we created the new, MEATIER Beyond Burger™. With mouthwatering marbling, a meatier chew, and all the juicy, GMO-free deliciousness you loved in the original, this new burger is closer to beef than ever before,” its website reads.

Brown was often asked by his mother: “Why are you so focused on perfectly replicating animal protein? Why don’t you just build a new source of protein for the front of the plate that people get really excited about?” I think we ought to earn that right. We have to prove that we can do this because the only thing that I know with absolute certainty about the consumer is that the consumer loves meat… Most of us do. Around 94 percent of the population here in the United States. And so that’s a really clear target for me,” Brown responds.

Brown, whose company entered the US stock market earlier this year, described the burger as a ‘stop along that way’, telling CNN Business: “It’s certainly not the end game.”

Shares of Beyond Meat were up more than 10% in early trading Monday on news reported by CNN. Now, Beyond Meat shares are up more than 550% since the company’s IPO in early May.

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Kansas Mom Had Her Children Take Doses Of Industrial Bleach Or Miracle Mineral Solution (MMS) — The Police Response Raised Eyebrows

A mom from Kansas has been administering bleach to cure her sons' autism but police shrugged reports off with Youtube videos as proof. Click To Tweet

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A mom from Kansas has been administering bleach to cure her sons' autism but police shrugged reports off with Youtube videos as proof.
Miracle Mineral Solution is just bleach. Photo: Your Best Digs | Flickr | CC BY 2.0

]ust when the public health community is starting to think that they have already got a little hold on the medical misinformation against vaccination, another pseudoscientific cure known as “Miracle Mineral Solution” or “MMS” is now gaining traction among different social media platforms, especially in Youtube and Facebook — as various “testimonials” are sprouting in support of this so-called miracle cure.

Miracle Mineral Solution or MMS promises to cure various diseases like autism, acne, HIV, hepatitis, flu, and malaria. It sounds well-intentioned except that MMS is chlorine dioxide, the scientific term for industrial bleach. These “testimonials” are advocating for parents to use industrial bleach to cure their children’s illness even against the warning of established health institutions regarding the potential health problems that taking in bleach inside one’s body could cause.

The Food and Drug Administration has warned that MMS “can cause serious harm to health” and said the agency “has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.” According to the FDA, anyone who started administering this “cure” should stop immediately and “throw them all away.”

Youtuber promotes MMS based on experience with her own sons

One particular Youtuber has opened her channel to preach about the health benefits of MMS. Her name is Laurel Austin of Lenexa, Kansas. According to her videos, she has started feeding her children, whose four out of six of them has autism, with chlorine dioxide and she said that the “cure” has helped her children manage the symptoms of autism.

According to an NBC News report, the first time she fed one of her sons the bleach solution, she filmed the moment and shared it with her thousands of subscribers. Reporter Brandy Zadrozny described the video, writing that after the young man, who has autism, took the solution, “his arms seem to twist around one another involuntarily, and he screams into his forearm before taking a bite of a banana.”

Considering the predicament the mother is experiencing, having four children with autism, it was reported by various sources that by reviewing her social media accounts, it is easy to say that the mother has been trying different alternative cures to help her children. According to a review of her social media accounts and documents from Lenexa police department, Austin has given regular doses of chlorine dioxide to her two sons, aged 27 and 28.

The police and adult protective services did not do anything about it

According to reports, the father of the children, Bradley Austin, has been trying to have his ex-wife stop from administering the chemicals to his sons since he found out what she was doing in January. However, according to reports, notwithstanding the statements made by Bradley Austin to the authorities, the Lenexa police department and Kansan adult protective services decided not to do anything regarding the matter. The dismissal from law enforcement reportedly baffled Bradley, who told NBC News, “I just want her to stop.”

In defence of the police department, they said that following Bradley Austin’s reports regarding the MMS usage of his ex-wife against their children, a police officer has consulted with a pharmacist at a state poison control center who said it was unsafe. Then police visited Austin’s house where she said she was following the chlorine dioxide protocol of the Kerri Rivera, a prominent promoter of the treatment, which is not a medical professional.

Rivera has been very enthusiastic in championing the supposed health benefits of MMS since 2012. She even wrote a book regarding how the use of chlorine dioxide can purportedly cure autism, a book that she initially offered in Amazon, but the tech giant decided to remove it from its inventory in March citing the harmful contents of the said book. Rivera was also very active in attending interviews and webinars in Youtube to preach about anti-vaccination ideologies and other conspiracy theories. In one occasion, Austin was interviewed alongside Rivera regarding the effects of Miracle Mineral Solutions on her sons with autism.

Furthermore, police documents have shown Austin provided that police officers with several links to Rivera’s contents about chlorine dioxide protocol, and online articles from Autism Research Institute, which promotes the widely debunked notion that vaccines cause autism. A police officer wrote about the articles in the report saying, “This legitimizes the claim by Laurel of her use of MMS CLO2 as a holistic treatment approach.”

The documents also revealed that the police reviewed a list of supplements meant for one of the sons, which advised he take 16 doses of chlorine dioxide treatment each day, one every hour. This was reportedly signed and stamped by a primary care physician at Kansas University’s MedWest Family Medicine Clinic, Sarita Singh.

In her defense, Singh said previously that she approved the chlorine dioxide treatment because she believes it is “benign and not toxic.”

Nonetheless, when asked regarding the issue, both the hospital where Singh is on duty as well as Kansas adult protective services refused to comment citing that the medical cases of Austin’s children are confidential.

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