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Posted by On July 16, 2018

Smallpox as bioweapon? FDA approves first treatment drug in response to fears

Smallpox as bioweapon? FDA approves first treatment drug in response to fears

The Food and Drug Administration has approved the first drug for treating smallpox, a response to experts' fears that the virus could be used as a bioweapon.

TPOXX, or tecovirimat, is taken orally to treat smallpox "to mitigate the impact of a potential outbreak," pharmaceutical company SIGA Technologies said in a statement.

The World Health Organization declared smallpox eradicated in 1980, and vaccination for Americans against the virus was stopped, according to the Centers for Disease Control and Prevention.

The approval of the drug addresses concerns the smallpox virus could be used in biological warfare.

"This new treatment affords us an additional option should smallpox ever be used as a bioweapon," FDA Commissioner Scott Gottlieb, M.D, said in a st atement.

There exists "no immediate, direct threat of a bioterrorist attack using smallpox," according to the CDC.

Researchers tested the drug's effectiveness against smallpox through studies involving animals infected with the virus. The drug was also tested with human volunteers not infected with smallpox.

Headache, nausea, and abdominal pain remained the commonly reported side effects.

The virus spread largely through direct contact with people, said the FDA. Symptoms usually appeared 10 to 14 days after infection. They included fever, exhaustion, headache and backache, as well as a rash initially consisting of small, pink bumps progressing to pus-filled sores.

Follow Brett Molina on Twitter: @brettmolina23.

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Posted by On July 16, 2018

FDA issues alert on recall of heart drug over 'impurity'

The Food and Drug Administration is alerting health care providers and patients that several versions of a common prescription drug used to treat cardiovascular conditions are part of voluntary recall due to the presence of an "unexpected" chemical "impurity" considered a "probable human carcinogen" in the active pharmaceutical ingredient.

The U.S. recall includes products containing the drug valsartan as an active ingredient supplied by a Chinese company and made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries as well as valsartan/hydrochlorothiazide sold by Solco and Teva.

"We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards. This is why we've asked these companies to t ake immediate action to protect patients," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in the alert.

More than two dozen other countries have issued similar recalls, raising some concerns about supply. One news report said that there were more than 2.5 million prescriptions for the drugs involved in the recall dispensed in Canada last year.

Ireland said its "precautionary recall" affected some 60,000 patients.

In his statement, FDA Commissioner Dr. Scott Gottlieb said his "drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications."

The FDA alert noted, "Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products."

It is thought the impurity - n-Nitrosodimethylamine - contaminated the active pharmaceutical ingredient during the manufacturing process. The chemical, which is found in tobacco smoke and some consumer products, has been linked to liver and lung cancer in animals that breathed it for periods of more than several weeks.

The FDA web page which anyone taking one of the recalled valsartan-containing medications is advised to visit lists the problem in one of the recalled products as "detection of a trace amount of unexpected impurity - NDMA."

The FDA advises concerned patients to check the drug name and company name on the label of their prescription bottle or contact the pharmacy that dispensed the medicine for verification.

It says patients should contact their health care professional and continue to take the recalled valsartan -containing medicines until they have a replacement product.

Valsartan is described as an angiotensin-II-receptor antagonist used to treat hypertension, recent heart attack and heart failure. It is said to be available on its own or in combination with other active substances.

Novartis is the company that originally developed the drug that is now said off-patent and used as a component of other generic medications.

The European Medicines Agency began reviewing medicines containing the active substance valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China, on July 5.

The review was conducted at the request of the European Commission after the company detected N-nitrosodimethylamine in valsartan's active pharmaceutical ingredient possibly as a result of changes to the way it is manufactured.

The company supplies the ingredient to manufacturers producing some of the valsartan medicines available in the European Union, and some initial reports were that U.S. manufacturers were not affected.

NDMA is described as "a semivolatile organic chemical that forms in both industrial and natural processes."

It is classified by the United States Environmental Protection Agency as a probable human carcinogen. It was formerly used in the production of rocket fuel, antioxidants and softeners for copolymers. It is currently used only for research purposes.

The United Kingdom's regulatory agencies advised pharmacies there July 5 to recall "all batches of valsartan containing medicines made by Dexcel Pharma Ltd and Accord Healthcare as a precaution" as the result of an "urgent investigation."

Similar recalls were said to have been issued elsewhere including Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada Bosnia and Herzegovina, Bahrain and Malta.

The FDA has said it will "continue to investigate this issue and provide additional information when it becomes available." The investigation is said to include "investigating the levels of NDMA in the recalled products" as well as "assessing the possible effect on patients who have been taking them."

Patients and health care professionals are advised to report any adverse reactions from the recalled products to the FDA's MedWatch program.

Source: Google News US Health | Netizen 24 United States


Posted by On July 16, 2018

Worried About Dementia? You Might Want to Check Your Blood Pressure

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Keeping your blood pressure down can lower your risk for dementia. John Rensten/Getty Images hide caption

toggle caption John Rensten/Getty Images

Keeping your blood pressure down can lower your risk for dementia.

John Rensten/Getty Images

Every day, Dr. Walter Koroshetz, 65, takes a pill as part of his effort to help keep his brain healthy and sharp.

< p>The pill is his blood pressure medication. And Koroshetz, who directs the National Institute of Neurological Disorders and Stroke, says controlling high blood pressure helps him reduce his risk of dementia.

He also keeps his blood pressure down by exercising, and paying attention to his weight and diet. "I'm a believer," he says.

Koroshetz is urging other people with high blood pressure to follow his lead.

He's responsible for the institute's public health campaign called Mind Your Risks. Its goal is to let people know that there's a link between high blood pressure, stroke and dementia.

When blood pressure rises, it strains the tiny blood vessels that keep brain cells alive, Koroshetz says.

"With every pulse of your heart, you are pushing blood into these very small blood vessels in the brain," he says. And when the heart pushes too hard, as it does when blood pr essure is elevated, it can cause damage that can lead to a stroke.

At least two large studies have revealed an alarming trend among stroke patients, Koroshetz says.

"If you had a stroke, even a small stroke, your risk of dementia within the next two years was greatly magnified," he says. "So there's something about having a stroke that drives a lot of the processes that give rise to dementia."

The evidence is clearest for a type of dementia called vascular dementia. It occurs when something blocks or reduces the flow of blood to brain cells.

But high blood pressure also appears to increase a person's risk of developing Alzheimer's disease, which is associated with the accumulation of plaques and tangles in the brain.

If people knew about the link between dementia and high blood pressure, they might be more inclined to do something about it, Koroshetz says.

&qu ot;Only about 50 percent of people who have hypertension are actually treated," he says. "So I think there's a lot to be said for trying to get high blood pressure under control."

Koroshetz's campaign is getting some help from the Alzheimer's Association.

The group will present new research on blood pressure and Alzheimer's at its annual scientific meeting in Chicago, which starts July 22. And the group is encouraging people to control high blood pressure.

"The good news is that we can control blood pressure now," says Maria Carrillo, the group's chief science officer. "We can do that with exercise, with lifestyle, with healthy eating and also with medications."

Koroshetz is using all of these approaches. And he says other people with high blood pressure should follow his lead.

"When you get to be my age, you're going to be very grateful that you controlled your blood p ressure and exercised," he says.

Source: Google News US Health | Netizen 24 United States


Posted by On July 16, 2018

City Council candidate accused of posting wife's topless pic after restraining order issued: report

David Martinez, a St. Paul City Council candidate in Minnesota on Saturday, is accused of posting a topless photograph of his estranged wife on the campaign’s website after she filed a restraining order against him for domestic abuse.

David Martinez, a St. Paul City Council candidate in Minnesota on Saturday, is accused of posting a topless photograph of his estranged wife on the campaign’s website after she filed a restraining order against him for domestic abuse.

A St. Paul City Council candidate in Minnesota on Saturday is accused of posting a topless photograph of his estranged wife on the campaign’s website after she filed a restraining order against him for domestic abuse, reports said.

David Martinez, 38, an Independent, is accused of sharing the picture of his topless wife on a beach with a description of their ma rital conflict on his campaign website’s blog section.

“Yesterday afternoon, the Ramsey County Sheriff’s Department paid me a visit at work. They presented me with a restraining order that my wife had filed with the District Court,” read the blog post, as seen by Fox News. The website has since been deleted.

"Yesterday afternoon, the Ramsey County Sheriff’s Department paid me a visit at work. They presented me with a restraining order that my wife had filed with the District Court."

- David Martinez

The poster accused the wife of fabricating and making up “most of the testimony contained within the restraining order” which was attached to the post. “I am shocked and amazed that someone can make up a story just so they can kick someone out of their own home and take the kids away."

He told KARE11 on Sunday that his campaign blog and social media accounts were hacked.

According to The Star Tribune, his wife’s affidavit claims that he physically assaulted her on July 4 in their basement while the children were upstairs. She alleged that he followed her to the laundry room, grabbed her around her neck and pushed her into a shelving unit.

The wife said she left the house after Martinez threatened to physically throw her out. She later called police so she could take the children with her and collect personal items.

“I have grown increasingly fearful and concerned about David’s behavior and am scared for me and our children,” she said, according to the newspaper. “He has become more erratic, verbally abusive and confrontational. I would describe his behavior as ‘unhinged.’”

"I have grown increasingly fearful and concerned about David’s behavior and am scared for me and our children ... He has become more erratic, verbally abusive and confrontational. I would describe his behavior as ‘unhinged.'"

- The wife of David Martinez

The wife noted that Martinez acquired mace and a BB gun in case “anyone gets in his face.”

St. Paul Mayor Melvin Carter on Sunday urged Martinez to drop out of the race following the controversy, the Twin Cities Pioneer Press reported.

"David Martinez’s behavior is disturbing and has no place in our city," Carter said in a statement. "I wis h the best to his family and our entire community as we heal from the harm his acts have caused. He should drop out of the city council race immediately."

Martinez was also detained and banned for a year from the Target Field stadium on July 6 for disruptive behavior. A day before, he was arrested and banned from George Latimer Central Library for a month, the Tribune reported.

The candidate shared a video of his encounter with the security guards of the stadium filmed on his cell phone, claiming he was “assaulted by the security team.”

“No wonder people of co lor do not attend Minnesota Twins baseball games!” he said of the video. Martinez is of Puerto Rican heritage.

Lukas Mikelionis is a reporter for Follow him on Twitter @LukasMikelionis.

Source: Google News | Netizen 24 United States


Posted by On July 16, 2018

After 30 years, police say they've captured a child-killer who left a sickening trail of taunts

July 16 at 5:25 AM Email the author
A photograph of 8-year-old April Tinsley, seen in a garden that was dedicated to her in Fort Wayne, Ind., after she was killed in 1988. (Michelle Davies/Fort Wayne Journal Gazette/AP)

The message was slashed onto the weather-beaten planks of a barn in the empty farmland not far from where the girl’s body had been found.

Police in northern Indiana stared at the jerky handwritten scrawl in May 1990, realizing this was the most significant clue to drop in the region’s most publicized unsolved crime. In 1988, 8-year-old April Tinsley had been found killed and sexually assaulted. Two years later, police were now studying the white bui lding on a stretch of lonely rural road, fields running to the horizon on all sides. The message appeared to be a confession â€" as well as a taunt and a threat.

“I kill 8 year old April M Tinsley,” the barn read, according to a recently filed police affidavit. “[D]id you find the other shoe haha I will kill again.”

Although the message initially failed to steer investigators to April’s killer, it was not the last word from the alleged murderer. As the case stalled and hundreds of suspects were targeted and cleared, the girl’s alleged assailant would continue to haunt the Fort Wayne area. Grotesque messages â€" left with used condoms and Polaroids â€" were sent to other little girls who the alleged child-killer claimed were next on his list.

This reign of terror initially failed to direct police to a suspect. But the horrific messages did provide investigators with the DNA they would eventually use to zero in on a suspect â€" albeit once the right ad vanced science and technology came along.

On Sunday, investigators from the Fort Wayne Police Department and the Indiana State Police arrested John D. Miller in connection with April’s death. The 59-year-old is scheduled to make his first court appearance Monday morning. According to a probable-cause affidavit filed in Allen County Superior Court, Miller confessed when questioned about Tinsley’s death.

April Tinsley. (FBI)

Documents show the arrest was not the result of intense media attention over the years â€" the case was featured twice on “America’s Most Wanted” as well as a 2016 episode of “Crime Watch Daily” â€" nor the repeated pleas for information that followed the 30th anniversary of April’s death last April. Once again, the new lead in the cold case is thanks to the dramatic scientific breakthrough pai ring forensic DNA with genealogical research.

The new science has led to a run of cold-case arrests, including the prosecution of alleged “Golden State Killer” Joseph James DeAngelo and an arrest in the 1992 murder of Pennsylvania schoolteacher Christy Mirack. Court records indicate the break in April’s case came thanks to Parabon NanoLabs, a company based in Reston, Va., that is at the center of many of the recent high-profile cases.

It was chilly on April 1 â€" Good Friday â€" 1988, the sky in Fort Wayne bruised over with threatening storm clouds. April Tinsley â€" a blond-haired, dark-eyed first-grader â€" left her home for a friend’s house two streets away. When April failed to walk through the door by dinnertime, her mother reported the little girl missing. “You’re sitting there looking out the window and trying to think, ‘Where is she? Who’s got her?’ ” Tinsley’s mother, Janet Tinsley, told Crime Watch Daily in 2016.

Three d ays later, a jogger spotted the body of a child in a water-filled ditch twisting through the rural fields of nearby Amish country. One of Tinsley’s shoes was found 1,000 feet from where she was located, according to court documents. Police also recovered a sex toy in a shopping bag left near the site. An autopsy showed the victim had been sexually assaulted and asphyxiated.

“You got an 8-year-old girl that was sexually assaulted and strangled,” Fort Wayne Police Detective Cary Young told Crime Watch Daily. “She suffered, and we don’t know exactly how long she suffered. It could have been three days of horror.”

Witnesses recounted seeing a girl matching April’s description being forced into a blue truck near her house. A description of the suspect was circulated, but investigators failed to track down any substantial leads. DNA evidence found in the girl’s underwear also did not initially point to a perpetrator. The barn message scrawled two years later in 1990 unnerved the community. But again, the taunting note produced nothing in terms of immediate concrete investigative evidence.

In 1990, police discovered a message on a barn door apparently left by April Tinsely’s killer. (FBI)

But the alleged killer surfaced again 14 years later.

In 2004, four notes were left at homes scattered across the Fort Wayne area. Three of the messages â€" written on lined yellow paper â€" were placed on young girls’s bicycles. An additional note was put in a mailbox. Three of the messages were inside plastic bags with used condoms and Polaroid pictures of the sender’s nude lower body. Several of the notes referred to April.

“Hi honey,” one note read, according to a picture released by the FBI. “I been watching you I am the same person that kinapped an rape an kill Aproil Tinsel y you are my next victim.” The same message demanded that the young girl report the note to the police; the writer said that if they didn’t see an article on the message in the newspaper or on the local TV station, they would blow up the child’s house.

Again, the letter did not immediately point police toward a suspect. But the DNA material recovered from the condoms matched the evidence recovered from Tinsley’s underwear â€" concretely linking the deranged 2004 notes with the 1988 killing.

Years passed. The case flickered in and out of the national spotlight. Last April, to mark the 30th anniversary of April’s murder, Janet Tinsley decided to hold a balloon release in a small neighborhood park dedicated to April near her home. More than 70 people attended, sending balloons up into the gray April sky.

“We thought ain’t nobody really going to show up,” Janet Tinsley told the Fort Wayne Journal Gazette. “But then all the sudden we see a lot of pe ople. It made me pretty happy. And hopefully they’ll continue supporting her, and thinking of her, and bringing up her name.”

According to the recently filed court documents, by the next month, the case had taken a dramatic turn.

In May, the Fort Wayne Police Department submitted the suspect’s DNA to Parabon NanoLabs. Using public genealogy databases, the firm’s researcher CeCe Moore was able to narrow the possible suspects down to two brothers in the Fort Wayne area.

In 2004, April Tinsley’s killer allegedly left notes for other young girls, threatening that they would be next. (FBI)

Police tracked one â€" Miller â€" to a trailer park in Grabill, Ind., outside Fort Wayne. Investigators pulled trash from the location, including three used condoms Miller had allegedly discarded. According to the probable-cause af fidavit, the DNA from the recently obtained condoms matched the DNA from the 2004 condoms, which matched the genetic profile found on the victim.

On Sunday, two detectives approached Miller outside his trailer and asked him to come to the police station to talk. There, after advising Miller of his rights, the detectives asked him whether he knew why they wanted to speak with him.

“April Tinsley,” the suspect allegedly told police, according to the affidavit.

According to the court document, Miller confessed after learning police had a DNA match linking him to the murder. He allegedly admitted to police he abducted Tinsley, took her back to his trailer and raped her. He allegedly strangled her to keep her from reporting the rape to police. Miller allegedly told police he dumped her body at night.

The next day he allegedly found the young girl’s shoe in his car. Driving past the ditch where he laid the body, Miller tossed the shoe in, too, he allegedl y told investigators.

Miller faces felony charges of murder, child molestation and criminal confinement. Authorities plan to offer additional information at a news conference Tuesday.

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Source: Google News | Netizen 24 United States