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FDA Recommends A New Drug To Cure Depression



FDA Recommends A New Drug To Cure Depression

Researches and extensive studies continue to contribute to the field of clinical science. The discovery of Prozac was an example of another breakthrough in its time, and after 25 years since its invention, there was no significant new treatment that has been developed.

However, another innovative treatment for depression is introduced recently, and it caught the attention of the Food and Drug Administration (FDA) panels. They eventually recommended the drug as a new depression treatment also known as an experimental drug in the form of a nasal spray which has a compound similar to the ‘club drug’ ketamine.

The influential panel voted for 14-2, with one member abstained from voting, in favor of Johnson & Johnson’s drug esketamine, a medical cure developed to treat major depression in patients who are not getting any improvement from at least two different therapies. According to the panel, the benefits of the nasal spray overshadowed the risks or side effects which include dizziness, nausea, and an unwanted feeling of dissociation.

Esketamine is a variation of the anesthetic ketamine which is treated as a recreational party drug with the cover name as ‘Special K.’ In many occasions, infusions or administering of ketamine into the vein have been revealed to help people with severe depression who usually have suicidal tendencies. However, researchers believe that the nasal spray will save people more time and be easier to use.

The nasal spray acts quickly after four hours, unlike other drugs which take more time to take effect. The primary goal why this research has is created to help 30 to 40 percent of patients with major depression who usually are resistant to anti-depressants, most of which take almost four weeks to see the development or result. Today, the only drug which is approved by the FDA for treatment of depression is called Eli Lilly’s Symbax.

For Walter Dunn, a panel member who voted for the approval, the said anti-depressant drug has the potential to be a game-changer in the treatment of depression. However, the FDA also needs to address the issues on the cost and accessibility of patients to this drug.

Based on the NBC news report, major depressive disorder (MDD) affects over 300 million people around the world, and 20 percent of the general population who have this condition attempted suicides. With the growing number of suicides due to depression, researchers feel the need to act as soon as possible to prevent further deaths.

The FDA, although not mandated to follow the panel’s recommendation strictly, will announce its final decision regarding esketamine on March 4 this year.

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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Trump Signs Executive Order On Disclosing Health Care Costs

Trump signs an executive order that makes health care providers and insurers to disclose costs information on services to make patients and families aware of what and how much they are paying Click To Tweet



Trump Signing Executive Order | Photo Screenshot From PBS News Hour YouTube

President Donald Trump signed an executive order Monday aimed at the US health care system along with his promise of “putting Americans first” by curbing costs and revolutionizing the current system.

The new law will direct the Department of Health and Human Services to establish regulations on health care providers and insurers that they work, alongside patients and families, with more transparency on costs by disclosing negotiated rates for services, as well as, provide patients with out-of-pocket expenses before offering services.

“This is bigger than anything we’ve done in this particular realm,” Trump said during the signing of the new law at the White House. “It’s pretty much going to blow everything away.”

The current health care system works by providing patients medical services related to their situation without going over the costs or the fees associated with the service. Furthermore, it is not directly disclosed which service/s the insurer pays. This method allows hospitals and insurers to assign the same set of health care plans but at varying costs depending on the patient.

Also, in this system, neither the patient nor the family is made aware of the costs they are going to pay until a billing statement is given before paying at the cashier.

“Often, prices differ drastically between providers and hospitals for the exact same services and there is no consistency; there is no predictability. There’s frankly no rhyme or reason to what’s been happening for so many years,” Trump said.

“Everyday American patients are being taken advantage of by a system that hides critical information from them that they need to make decisions for them and their families,” Health and Human Services Secretary Alex Azar said.

The executive order, which discloses information both to the patients and the federal government, would allow patients and families make sound decisions on which health care plan best suits them and at which prices.

According to Trump, “the cost of healthcare will go way, way down” as price transparency will create greater competition.

Furthermore, the executive order will also pave the way to put an end to “surprise billing” instances where patients are made known weeks to months after that insurance companies cannot cover a provided service.

“The president has a clear vision for American health care,” Azar said. “Today, the president is delivering on that historic promise,” and that this will “go down as one of the most significant steps in the long history of American health care reform.”

The reform, still in its early days, remains unclear how the federal government will put information out to the public. A senior administration official said that whether patients would have access to a full database of specific prices or something closer to a range of prices would be decided during the regulatory process. What is most likely is that privacy will be maintained on individual patient information.

“Exactly what information hospitals and insurers will have to disclose is not specified in the executive order, which has no force of law on its own,” The New York Times reported Monday. “White House officials said the details would be worked out during the rule-making process. Hospitals and insurance companies are likely to lobby to make any disclosures as general as possible.”

Meanwhile, critics are saying that instead of creating more competition, the executive order will discourage more insurance companies instead and drive prices higher.

“Publicly disclosing competitively negotiated, proprietary rates will reduce competition and push prices higher — not lower — for consumers, patients, and taxpayers,” said Matt Eyles, CEO of America’s Health Insurance Plans in a statement. He says it will perpetuate “the old days of the American health care system paying for volume over value. We know that is a formula for higher costs and worse care for everyone.”

When discussions began earlier in the year on the topic, Thomas P. Nickels, executive vice president of the American Hospital Association, said that the proposal is “a radical idea, requiring the disclosure of privately negotiated rates between two parties in a contract,” the Times reported in March. “It would be impractical because a hospital may have contracts with a dozen insurers, and each insurer may have four or five different health plans with different terms.”

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Prenatal Surgery Could Make Abortion Obsolete?



Photo by Ignacio Campo on Unsplash

Innovation in the medical industry paved a new way for prenatal surgery to be available to the general public. In light of the situation, pro-life advocates are praising the ability to improve the quality of life rather than putting an end to it—claiming that abortion can now be rendered obsolete.

Prenatal surgeries or fetal surgeries are medical procedures where a practitioner operates on the baby before it is even born. The surgery would allow the fetus to develop in better circumstances as compared to having the operation after labor. Specifically, doctors would recommend this for fetuses with specific life-threatening congenital abnormalities.

Prenatal surgery is a relatively new and growing branch of medicine. However, the procedure was first introduced and performed in the early 80s, but the complexity and lack of needed technology hampered its growth. In 2019, the situation is looking better with new technological advancements.

According to the Centers for Disease Control and Prevention (CDC), congenital disabilities affect one in every 33 babies born in the United States each year. Out of that number, 20% of all infants die, making the problem the leading cause of infant mortality.

Accurately, in cases of Spina bifida (myelomeningocele), which can render a person quadriplegic, can be detected and treated during pregnancy. However, once untreated, the defect can be incredibly hard to manage because the damage is taking place from the womb up until the fetus is born and continues with the child’s growth. The defect affects 1 in 2,858 cases and 1,460 cases a year.

Pro-life activists claim that because of cases like these, parents opt to have their fetus aborted than raise them with poor quality of life. However, with the rise of prenatal surgeries that can prevent or correct these said defects, children can grow with better chances and should hamper abortion rates.

The claim boomed after a recent New York Times feature, where a 17-month old baby was successfully operated for Spina bifida via prenatal surgery when he was only six months old.

Doctors explained the fetal surgery used an advanced approach called a fetoscopic operation, a surgical procedure developed at Texas Children’s Hospital by Dr. Michael A. Belfort, the obstetrician and gynecologist in chief, and Dr. William Whitehead, a pediatric neurosurgeon.

Notably, a fetoscopic operation allows doctors to make a small incision on the uterus and insert tiny cameras to function as the surgeon’s eyes while operating inside the mother’s womb. The “experimental” procedure is said to be a better alternative to a hysterectomy where the mother’s womb is opened to expose the baby and perform the surgery partially.

“Fetal surgery is not a cure,” Lexi Royer, the mother, said. “Damage was done before the surgery, and all they can do is close it up so the damage doesn’t get worse. He’ll have to be monitored for the rest of his life. He’ll have this condition for the rest of his life. His outcome is great. But things could change.”

In other news, surgeons at Cleveland Clinic in Ohio also say that a baby girl was born healthy after undergoing the hospital’s first-ever fetal surgery for the same defect.

Dr. Darrell Cass, director of fetal surgery at Cleveland Clinic’s Fetal Center, led the multispecialty team. Cass has performed more than 160 fetal surgeries for other conditions since 2002, the Daily Mail reported.

Meanwhile, according to the Children’s Hospital of Philadelphia’s website, a host of conditions can be treated with fetal surgery, including:

-Amniotic band syndrome
-Bronchopulmonary sequestration of the lung
-Congenital cystic adenomatoid malformation of the lung (CCAM)
-Congenital diaphragmatic hernia (CDH)
-Congenital high airway obstruction syndrome (CHAOS)
-Intrauterine transfusion (IUT)
-Lower urinary tract obstruction (LUTO)
-Mediastinal teratoma
-Neck mass
-Pulmonary agenesis
-Sacrococcygeal teratoma
-Spina bifida (myelomeningocele)
-Twin reversed arterial perfusion sequence (TRAP sequence)
-Twin-twin transfusion syndrome (TTTS)

Prenatal surgeries are growing to be a procedure with increasing success rates and are partnered with parents’ success stories. It is a revolutionary milestone for parents seeking a good quality of life for their children. However, the claims of this science rendering abortion obsolete remains vague.

Based on the latest state-level data, approximately 879,000 abortions took place in the United States in 2017—down from around 892,000 abortions in 2016 and 913,000 abortions in 2015. However, only a small 3% of which decided on abortion with consideration of their fetus’ health. Another 3% accounted for the mother’s health and capability of giving birth.

Meanwhile, 25% still claim that they get an abortion because they are not ready to have a child, and 23% do because they cannot afford to raise one.

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Cannabidiol From Cannabis Could Be A Powerful New Antibiotic

Researchers found that Cannabis can be a powerful new source of antibiotics that could help the growing issue of antibiotic-resistant bacteria Click To Tweet



Photo by Kimzy Nanney on Unsplash

New research has found that the non-psychoactive compound extracted from the cannabis plant or Cannabidiol could potentially become a powerful new antibiotic.

The research presented at the ASM Microbe, an annual meeting of the American Society for Microbiology, found that Cannabidiol is active against Gram-positive bacteria, including those responsible for many serious infections such as Staphylococcus aureus and Streptococcus pneumoniae, with a potency similar to that of established antibiotics such as vancomycin or daptomycin.

Cannabis is considered legal across ten states in America because it promises to be a new source of drugs due to its medicinal properties that researchers are still to develop. Furthermore, it has shown that people can benefit from it for a variety of illnesses.

Since becoming legal, CBD is found to be effective against inflammation, anxiety, and some cases of Parkinson’s disease. Recently, researchers published a study indicating that the drug can help former drug addicts transition back to regular day-to-day life with the aid of CBD drugs. Furthermore, it has encouraged a slew of enterprises and businesses to focus on Cannabis and CBD to create new products.

Today, researchers are adding CBD as a possible powerful antibiotic to the list of medical benefits that the drug can offer. In a study, scientists found that CBD killed all the strains of bacteria that they tested it with on a lab, including some that are highly resistant to existing antibiotics.

In the experiment, scientists used CBD as a topical antibiotic (medicine placed on the skin’s surface such as creams) against Gram-positive Staphylococcus aureus—causes conditions including the hospital bug MRSA—and Streptococcus pneumoniae—which leads to pneumonia—as well as E. faecalis, which can be life-threatening in those with weak immune systems.

In addition to the results, the researchers also found that the bacteria did not become resistant to the drug after being exposed for 20 days: the period when bacteria can survive some currently used drugs.

Study leader Mark Blaskovich, a senior research chemist at the Centre for Superbug Solutions, told Newsweek: “We still don’t know how it works, and it may have a unique mechanism of action given it works against bacteria that have become resistant to other antibiotics, but we still don’t know how.”

“So far, we have only shown it works topically, on the skin surface. To be really useful, it would be good if we could show that it treated systemic infections e.g. pneumonia, or complicated tissue infections, where you have to give it orally or by intravenous dosing. A very preliminary study didn’t show that it works in these more difficult models.”

Nevertheless, the study’s findings pose as another possible benefit factor to the drug in light of the current “global crisis” that antibiotics are facing says the World Health Organization (WHO). Particularly, bacteria is growing immune with the current antibiotics that’s available to the general public.

Ever since the WHO announcement in 2015, pharmaceutical companies have been finding ways of devising new antibiotics from different sources to combat the impending crisis that’s threatening thousands of lives.

In related news, researchers discovered that antibiotics levels found in the world’s rivers were at unsafe levels. This is largely a result of human waste ending up in the water systems. However, scientists warn that it could boost the current problem with how bacteria are growing resistant to drugs because of wildlife intervention.

CBD could help close the door on the threat with further development, given that it is already proving to be a pharmaceutical investment because of its health benefits.

In other publications, CBD is found to be the most proven with its effectiveness in treating some of the cruelest childhood epilepsy syndromes, such as Dravet syndrome and Lennox-Gastaut syndrome (LGS), which typically don’t respond to anti-seizure medications. Harvard Health Publishing wrote that “in numerous studies, CBD was able to reduce the number of seizures, and in some cases, it was able to stop them altogether. Videos of the effects of CBD on these children and their seizures are readily available on the Internet for viewing, and they are quite striking. Recently the FDA approved the first-ever cannabis-derived medicine for these conditions, Epidiolex, which contains CBD.”

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