TIME medicine

World’s First Malaria Vaccine Could Be a Year Away

A Thai public-health official places a thermometer into a child's mouth at a malaria clinic in Sai Yoke district, Kanchanaburi province, Thailand, on Oct. 26, 2012 Sukree Sukplang—Reuters

Researchers published promising findings, while a pharmaceutical company applied for the first-ever regulatory approval of malaria vaccine

The world’s first malaria vaccine may just be a year away, after a thorough trial of a new drug showed promising results.

PLOS Medicine on Tuesday published a study, in which researchers found that for every 1,000 children who received the vaccine, 800 cases of illness could be prevented. The children also retained protection 18 months after being injected.

Now, pharmaceutical manufacturer GlaxoSmithKline (GSK) has applied the drug for regulatory approval — the first time a malaria vaccine has reached this stage.

“This is a milestone,” Sanjeev Krishna, professor of molecular parasitology and medicine at St. George’s, University of London, who reviewed the paper for the journal, told the BBC. “The landscape of malaria-vaccine development is littered with carcasses, with vaccines dying left, right and center. We need to keep a watchful eye for adverse events, but everything appears on track for the vaccine to be approved as early as next year.”

Around 800,000 people die from malaria every year, most of them children under 5 in sub-Saharan Africa. Several African countries were involved in the trial of the new vaccine, which is developed by GSK in cooperation with the nonprofit Path Malaria Vaccine Initiative, for which they have received funding from the Bill & Melinda Gates Foundation.

TIME Research

The Link Between 9/11 and Cancer Still Isn’t Entirely Clear

National 9/11 Memorial Museum
People visit the National 9/11 Memorial Museum in New York City on May 25, 2014. Cem Ozdel—Anadolu Agency/Getty Images

A number of complicating factors and delayed data make conclusions difficult to draw

The New York Post reported Sunday that the number of cancer cases among 9/11 first respondents had more than doubled in the past year, from 1,140 to over 2,500. However, to scientists who specialize in analyzing such data, the number of cases cannot ever tell the full story.

Dr. Roberto Lucchini is an epidemiologist and director of the World Trade Center Health Program Data Center at Mount Sinai Hospital, which treats and researches the police officers, construction workers, sanitation workers and iron workers who were among the first respondents on 9/11. To Lucchini, the number of observed cancer cases among these patients cannot be significant until compared to the number of expected cancer cases.

“I don’t think there’s a double of cases one year to the other,” Lucchini told TIME. “When you compare one year to the other, you have to be careful and try to understand what you are comparing. If you don’t compare correctly, you can come up with information that is not exactly true.”

“I don’t think they compared like-with-like which is what you normally do in epidemiology,” adds Dr. Billy Holden, a deputy director of the data center. “I don’t know how they came to the conclusion that there was a doubling.”

Mount Sinai has a record of 1,646 confirmed cancers from 2002 to present-day among the over 30,000 first respondents that they oversee. The hospital’s cases are reviewed and certified by the National Institute of Occupational Safety and Health (NIOSH). Meanwhile, the public registry—which also collects data on these cases—has confirmed 1,172 cancers among Mount Sinai patients, but the registry’s number only represents data through the year 2010, which may account for the difference.

“That’s the latest that we have in reliable data that we can use,” Holden says. “The delay is coming from the registries themselves. It takes them a long time to get the data.”

According to a press release from Mount Sinai, “analysis of available data through 2010 shows that there is an approximately 20% increase in cancer incidence in 9/11 rescue and recovery workers compared to the general population, with a particular increase in thyroid cancer, prostate cancer, myeloma, and leukemia.”

This elevated incidence rate could result from the high exposure to carcinogens that many first respondents endured. However, even this number is subject to question due to a number of complicating factors, including over-diagnosis of certain cancers—such as thyroid and prostate—and questionably reliable data for the general population.

“Over-diagnosis means you’re just screening for cancers, and you pick up cancers that in the normal course of things would never cause symptoms and would never cause death,” Holden says. “The screening for thyroid and prostate cancer is picking up these really non-malignant cancers that don’t do anything.”

Another complicating factor is the continued aging of the first respondents. Epidemiologists would expect the number of observed cancer cases among this population to increase over the coming years regardless because everyone’s risk of cancer rises with time. “Numbers are interesting, but they’re not revealing because we have to look at the rates,” Holden says. “Looking at numbers themselves doesn’t mean anything. You have to put them in a certain context.”

The search for a similar context alone can result in frustration for researchers. As so many residents of New York need not be reminded, 9/11 is an event that stands alone in our history.

“There’s nothing like this in the whole history of the world,” Lucchini says. “We can think about Chernobyl or Fukushima, but this is a totally different situation here… So for us to compare this to other studies and other experiences is quite difficult.”

Lucchini adds, “We are doing as much as we can.”

When it comes to the men and women who first responded on that fateful day, the question remains of how much can ever be enough.

TIME medicine

Tylenol and Panadol Prove No Better Than Placebo at Helping Back Pain

Paracetamol Reportedly Not Effective Drug For Back Pain
Paracetamol tablets sit on a table on July 24, 2014 in Melbourne, Australia. In a new study published in the prestigious medical journal, 'The Lancet' the most common pain reliever for back pain, paracetamol, does not work any better than a placebo. Scott Barbour—Getty Images

Acetaminophen isn't curing your aches after all

Two-thirds of adults experience back pain sometime during their lives, and most take acetaminophen, found in brands like Tylenol and Panadol, for relief. But new research has found that those medicines are no more helpful than swallowing a sugar pill.

A study published this week in a medical journal called The Lancet split 1,643 people with acute low-back pain into three groups, each given two boxes. One group received two boxes of 500-miligram acetaminophen tablets, with instructions to use the second box “as needed'; the second group got a box of acetaminophen and an as-needed box of placebos; and the third group received two boxes of placebos. Researchers told the participants to take six tablets per day from the regular box and up to two from the as-needed box.

Over the course of three months, the researchers found no difference among the three groups. Subjects showed no variation in terms of pain, recovery time, function, disability, symptom change, sleep or quality of life. About 75% of the participants were happy with their results, whether or not they had received the placebos.

TIME Health Care

Johns Hopkins to Pay $190 Million to Victims of Secretly Recorded Exams

A sign stands in front of part of the Johns Hopkins Hospital complex on July 8, 2014, in Baltimore.
A sign stands in front of part of the Johns Hopkins Hospital complex on July 8, 2014, in Baltimore. Patrick Semansky—AP

A male gynecologist secretly filmed and took pictures during exams with female patients

Johns Hopkins Hospital announced on Monday that it reached a $190 million settlement with patients whose exams were secretly recorded by a gynecologist.

The class-action lawsuit involved more than 8,000 former patients of Dr. Nikita Levy, the Associated Press reports, and the deal marks one of the largest involving sexual misconduct by a doctor. Most of the discovered videos and photographs—about 1,200 videos and 140 photos—did not include the women’s faces and were taken with a pen-like camera he wore around his neck.

The case never led to criminal charges but essentially argued that Johns Hopkins should have been aware of what the doctor was doing. Levy committed suicide 10 days after he was fired in February 2013, which occurred after an employee came forward with suspicions.

Johns Hopkins released a statement in October on the discovery of Levy’s “misconduct and breach of trust,” writing: “We have redoubled our efforts to ensure that all of us in the Johns Hopkins community understand our responsibility, and we want to encourage you to speak up if you have any concerns about patient care or privacy.”

In a statement sent to reporters, Jonathan Schochor, the lawsuit’s lead attorney, said: “When learning of Dr. Levy’s behavior, our clients were extremely distraught. They felt a great breach of faith and trust. They felt betrayed. Now, with this proposed settlement, we can begin the process of healing our community.”

The settlement still needs final approval by a judge, the AP reports.

“We assure you that one individual does not define Johns Hopkins,” the hospital system said on Monday, acknowledging the settlement. “Johns Hopkins is defined by the tens of thousands of employees who come to work determined to provide world-class care for our patients and their families.”

TIME Military

Navy Nurse Refuses Gitmo Force Feed Order

Guantanamo Hunger Strike
In this photo Nov. 20, 2013 file photo reviewed by the U.S. military, a U.S. Navy nurse stands next to a chair with restraints, used for force-feeding, and a tray displaying nutritional shakes, a tube for feeding through the nose, and lubricants, including a jar of olive oil, during a tour of the detainee hospital at Guantanamo Bay Naval Base in Cuba. Charles Dharapak—AP

A detainee described the act as a conscientious objection

A Navy medical officer at the U.S. military prison at Guantánamo Bay, Cuba has refused an order to continue force-feeding hunger-striking prisoners in what one detainee lawyer described as an act of conscientious objection.

“There was a recent instance of a medical provider not willing to carry-out the enteral feeding of a detainee. The matter is in the hands of the individual’s leadership,” a Pentagon spokesperson said in an email. “The service member has been temporarily assigned to alternate duties with no impact to medical support operations.”

It is the first known instance of a U.S. service member rebelling against the Pentagon’s force-feeding policy. An unknown number of the 149 detainees at Guantánamo’s Camp Delta have been on hunger strike for the past year and a half to protest their indefinite detention.

News of the refusal comes to the public by way of an attorney for one of the detainees, who, according to The Miami Herald, says his client described how some time before the Fourth of July a Navy medical nurse suddenly shifted course and refused to continue force-feeding prisoners. The nurse, he said, was abruptly removed from duty at the detention center. The attorney said his client described the nurse’s action as a conscientious objection.

The Herald reports that the prisoner who provided news of the incident described the nurse as a roughly 40-year-old Latino man most likely with the rank of lieutenant in the Navy.

Last year, civilian doctors writing for the New England Journal of Medicine declared that medical professionals taking part in force-feeding was unethical and called the Guantánamo medical staff to refuse to participate.

TIME medicine

Study: Phones, Tablets May Irritate People With Nickel Allergies

Ken Miyauchi, vice president and chief operating officer of Softbank Corp., left, holds an Apple Inc. iPad Mini during a ceremony as the device goes on sale at the Softbank store in the Ginza district of Tokyo on November 30, 2012.
Ken Miyauchi, vice president and chief operating officer of Softbank Corp., left, holds an Apple Inc. iPad Mini during a ceremony as the device goes on sale at the Softbank store in the Ginza district of Tokyo on November 30, 2012. Bloomberg/Getty Images

One boy had skin rashes from his iPad

A nickel allergy is one of the most common types of skin allergies, causing many people to experience irritation from jewelry, for example. New research shows that nickel allergies are becoming more common among kids, with one case being triggered by exposure to an iPad tablet.

In a recent case study published in the journal Pediatrics, an 11-year-old boy with a history of skin rashes had a particularly persistent breakout that lasted over six months. The doctors ultimately determined the trigger was nickel in his family’s iPad. An iPad cover was added, the boy changed his diet, and the rashes improved.

Apple did not respond to requests for comment.

The report’s authors say dermatologists should be mindful that some electronic devices may cause irritation for people with nickel allergies. As the Associated Press reports, only about 25% of children tested for skin allergies are allergic to nickel. Individuals who have no problems when it comes to the metal — the majority of people — shouldn’t worry about the nickel in their gadgets.

 

TIME

Dad-to-Be Films the 95 MPH Race to the Hospital for the Birth of His Child

GoPros aren't just for extreme sports anymore.

What do you do when your wife is pregnant and you need to get out of the house as soon as possible and rush to a hospital? Stick a GoPro camera in your car and record the whole thing, of course.

Troy Dickerson filmed his wife Kristin being driven to the hospital at speeds in excess of 95 miles per hour, recording himself trying to soothe her as she moans in pain. They pull up to the hospital’s car port, but Kristin can’t make it inside—she gives birth right out of the car. It’s amazing that everything went as smooth as it did, all things considered.

And when the baby is grown up, they will be able to watch their entire emergence into the world in HD! Good for them, I guess? At least they can time-lapse the footage.

TIME georgia

Georgia Governor Pushes Trials Of Marijuana Derivative

Georgia Medical Marijuana
Gov. Nathan Deal gives a news conference on clinical trials of a marijuana-derived oil at Children's Hospital of Georgia in Augusta, Ga. on Tuesday, July 8, 2014. Jon-Michael Sullivan—AP

Deal said the Georgia clinical trial would hopefully be up and running by the end of the year or the first part of 2015

(AUGUSTA, Ga.) — Georgia’s governor is pushing clinical trials for a marijuana-derived drug that proponents say could help treat severe seizure disorders among children, an unlikely election-year move for a Republican in a conservative part of the country that is just beginning to warm up to medical marijuana in narrow circumstances.

Since 1996, 23 states around the country and the District of Columbia have legalized comprehensive access to medical marijuana, and two have decriminalized the drug entirely. But the South has largely resisted out of fears it could lead to widespread drug abuse and other social ills.

This year, though, six Southern states adopted laws establishing some limited access to marijuana products that have minimal or no tetrahydrocannabinol, or THC, the psychoactive compound in marijuana that makes users feel high. A similar effort in Georgia failed on the last day of the legislative session, which prompted Governor Nathan Deal — a Republican up for re-election — to take action to coordinate clinical trial programs in the state.

“We all have to be sensitive to the children who have these seizures, and that is the focal point for all this discussion,” Deal said Tuesday after meeting with various representatives involved in establishing the clinical trials. “I want it to be helpful, not harmful. And I want it to be legal, and that’s why we are taking the steps to make sure we achieve all of those goals.”

Also Tuesday, another conservative state, Utah, issued its first registration card under its limited medical marijuana program geared toward those with severe epilepsy. Under Utah’s program, the marijuana extract known as cannabidiol can only be obtained from other states and with a neurologist’s consent. The extract can be administered orally.

Meanwhile, Washington was at the other end of the spectrum as Tuesday marked the first day residents of that state could buy marijuana legally without a doctor’s note.

In the South, the key to widespread acceptance has been the advocacy of parents who say their children suffering from severe seizure disorders could benefit from the use of the cannabidiol, although scientific research remains limited.

Deal said the science is not settled, which is why the clinical trials are so crucial. Under Georgia’s plan, the state through Georgia Regents University in Augusta will be partnering with London-based GW Pharmaceuticals for an expanded clinical trial. The company also has a research partnership with New York and is conducting trials in several states.

Deal said the Georgia clinical trial would hopefully be up and running by the end of the year or the first part of 2015. A separate clinical trial, which would be state-run, would require FDA approval, and it’s not yet known how long that will take, Deal said.

Valerie Weaver brought her 6-year-old son, Preston, who has Lennox-Gastaut Syndrome, to the governor’s event at Children’s Hospital of Georgia on the campus of Georgia Regents University. Weaver said she was hopeful the trials could help her son, who suffers from 60 to 80 seizures a day.

“It’s time we get with the program,” Weaver said, noting education is key to broader acceptance. “It’s the Bible Belt. The only thing I can tell people is to educate yourself.”

TIME Drugs

Natural Depression Supplements’ Dangerous Drug Interactions

St. John's wort alternative medicine
Raphye Alexius—Getty Images/Image Source

St. John's wort can interact dangerously with many common drugs

Physicians may need to more carefully communicate the risks of natural treatments, a new study finds.

St. John’s wort—the most frequently used alternative medicine for depression—reacts dangerously with many common medicines, but it turns out many people taking the supplement don’t know that.

A study from Wake Forrest Baptist Medical Center looked at data from 17 years of the National Ambulatory Medial Care Survey and found that 28 percent of patients who said they were taking St. John’s wort were also taking drugs that have potentially dangerous interactions with the supplement. Many of those drugs are widely prescribed and taken.

The most dangerous interactions come from selective serotonin reuptake inhibitors (SSRI antidepressants) and benzodiazepines. Other drugs that can interact dangerously with St. John’s wort include oral contraceptives, blood thinners, cancer chemotherapy medicines, digoxin, HIV medicines, statins, immunosuppressants, and verapamil. When St. John’s wort is combined with some drugs, they can reduce the concentration of the prescribed drugs in the body, leading to impaired efficacy and treatment failure.

Herbal supplements fall under a category called “dietary supplements,” and manufacturers do not need FDA approval before putting them on the market, according to the Mayo Clinic.

“The treatments that you can buy over the counter are not regulated as heavily as things you’re prescribed,” says study co-author Scott Davis. “Just because they’re natural doesn’t mean they’re safer.”

Davis, a researcher at Wake Forest School of Medicine, says he was surprised by how many people were prescribed dangerous combinations of drugs. But the real number could be even higher. He believes some patients might feel embarrassed to tell their physicians they are taking natural treatments, which could prevent them from learning about potentially dangerous consequences.

“There are certainly lots of physicians out there who prescribe alternative medications,” says Davis. “Patients should inform physicians of all supplements, vitamins, minerals—anything they are taking—and make sure to ask before a physician prescribes another drug if there are interactions they should know about.”

TIME medicine

Painkiller Use High Among Soldiers Returning From War, Study Finds

A soldier salutes the flag during a welcome home ceremony for troops arriving from Afghanistan on June 15, 2011 to Fort Carson, Colorado.
A soldier salutes the flag during a welcome home ceremony for troops arriving from Afghanistan on June 15, 2011 to Fort Carson, Colorado. John Moore—Getty Images

Of the 2,597 soldiers surveyed, 15% had taken opioids in the past month. Among civilians, that number is around 4%

A study published by a U.S. medical journal found that soldiers returning from war experience pain and take prescription opioids much more than civilians.

U.S. Army researchers surveyed an infantry brigade that had recently come home from Afghanistan. Of the 2,597 soldiers, 44% reported experiencing chronic pain that lasted for three months or more. 15% had taken opioids in the past month.

By contrast, the study’s authors suggest that 26% of civilians endure chronic pain, whilst 4% take opioids. Robin Toblin, who led the study, told the Los Angeles Times: “We were surprised by the percentages.”

Of the 1,131 soldiers who experienced chronic pain, nearly 14% described it as “severe”. Combat injuries were the main reason for the pain whilst rates of chronic pain were higher in those suffering from post-traumatic stress disorder and depression. 60 soldiers said the pain was so bad that they were taking opioids nearly every day.

The study, published in the JAMA Internal Medicine noted that use and misuse of opioids, prescribed for chronic pain, has “ballooned” recently. But experts said the study didn’t answer the questions it raised about whether opioids are being correctly prescribed.

“American medicine in general is overprescribing,” said Dr Mark Edlund, a psychiatrist and pain expert who was not involved with the survey.

The study did suggest some soldiers might have been incorrectly prescribed opioids. Amongst those taking the drugs, 17 soldiers said they experienced no pain and 144 reported it as “mild”.

Painkillers such as oxycodone and hydrocodone have faced a public backlash as addiction rates and fatal overdoses continue to increase. These drugs are considered most beneficial for short-term pain. When prescribed for chronic pain, the benefits might not exceed the risks.

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