$8 Billion Award in Risperdal Lawsuit

A lawsuit over the antipsychotic drug Risperdal has led to an $8 billion punitive damages award against Johnson & Johnson and one of its subsidiaries.

The award was handed out Tuesday by a Philadelphia jury. The plaintiff's attorneys argued that the drug is linked to abnormal growth of female breast tissue in boys, the reported.

In a statement, attorneys Tom Kline and Jason Itkin said Johnson & Johnson used an organized scheme to make billions of dollars while illegally marketing and promoting the drug.

Johnson & Johnson said the award is "excessive and unfounded" and that it would take immediate action to overturn it, the reported.

Mind-Controlled 'Exoskeleton' Restores Movement to Totally Paralyzed Man

By Alan Mozes

FRIDAY, Oct. 4, 2019 (HealthDay News) -- Unable to move either their arms or their legs, quadriplegics are almost completely paralyzed. But in a major breakthrough, a team of French researchers has given one patient the ability to move all four limbs.

How? With the assistance of a whole-body exoskeleton controlled by a patient's brain waves.

"For the first time, a quadriplegic patient was able to walk and control both arms using this neuro-prosthetic, which records, transmits and decodes brain signals in real time to control an exoskeleton," said project chief Guillaume Charvet. The experiment was launched by the biomedical research center Clinatec in Grenoble, France.

At the heart of the two-year investigation was a single patient: Thibault, a 30-year-old man from Lyon who does not want his surname used. Four years ago, Thibault lost the ability to move any of his limbs following an accident that caused him to fall more than 40 feet.

But in 2017, two small wireless sensors (each containing 64 electrodes) were implanted on opposite sides of his brain, in an area central to both movement and sensation control.

The sensors would record and wirelessly convey brain signaling to the exoskeleton, which could then turn it into machine-enabled movement.

To facilitate that process, Thibault spent more than three months working with a high-tech computer simulation program to learn how to control an on-screen representation -- much like a video-game avatar -- of his appendages.

With his sensor-read thoughts, Thibault eventually learned to manipulate those digital arms and legs, so he could virtually walk and pick up virtual objects.

Those skills were then attempted on the exoskeleton, which looks like a high-tech suit of white armor split in half and fitted to the patient from behind, like a rigid cape.

Outfitted with 14 joints and 14 degrees of freedom, the exoskeleton is designed to enable movement in about 14 unique ways, the researchers noted.

To see how many of those moves he could actually make, Thibault underwent a series of arm and leg movement tests. After 45 sessions in the exoskeleton, the study team deemed the final results a success.

Smog Particles Can Reach Developing Fetus: Study

       
       

TUESDAY, Sept. 17, 2019 (HealthDay News) -- Air pollution can penetrate a pregnant woman's placenta and potentially threaten the health of a developing fetus, new research warns.

The study is "the first to show that air pollution particles can reach the fetal side of the placenta," said study author Hannelore Bove, a postdoctoral researcher with the Centre for Environmental Sciences and Biomedical Research Institute at Hasselt University in Diepenbeek, Belgium.

The finding follows an analysis of high-resolution images taken of placenta tissue retrieved from 28 women who had just given birth at East-Limburg Hospital in Genk, Belgium.

Five gave birth prematurely, while the remainder carried to term. In each case, placenta tissue was retrieved within 10 minutes after delivery.

Bove and the research team reported detecting black carbon particles -- most commonly produced by fossil fuel combustion -- in the placenta of all the participating mothers.

But the tissue of those residing in relatively polluted areas had collected notably higher levels of carbon particles in their placenta than those from less polluted locations.

The study is published in the Sept. 17 issue of .

Whether those particles definitely harm fetal development remains an open question. The researchers only set out to see whether pollution was present in the placenta. "This is the subject for another study," said Bove.

Still, the new findings underscore a basic fact: that a mother's environment is also the fetus' environment. And the placenta cannot offer foolproof protection from the outside world.

"The placenta's principal function is to deliver nutrition and oxygen to the fetus," explained study corresponding author Tim Nawrot, a professor of environmental epidemiology at Hasselt University. "But to some extent, it also forms a barrier against toxicants."

In fact, "decades ago it was thought that nothing can cross the placenta," said Bove. "And that the fetus is completely safe inside the womb."

But in the 1960s, the thalidomide crisis shattered that belief, she noted. The infamous sleeping pill's ingredients were found to have crossed the placenta in pregnant women, triggering massive birth defects.

Back-to-School Sports Test

Our kids are getting ready for a new school year. Along with all the school supplies we need to buy, we need to prepare for after-school activities, which often include sports.

If your child plays sports, most school districts and athletic leagues require an exam before your child can participate. The pre-participation physical examination is different from the yearly physical exam and well-check you might be used to for your child.

A key part of this exam is medical history, especially your family's medical history. You will be asked about your child's or family members' history of diseases -- such as asthma, epilepsy, and diabetes -- as well as instances of dizziness and palpitations. None of these conditions automatically excludes your child from doing sports, but they are important to be aware of, as your child’s activities may be limited, or they may need accommodations. For example, some children only have asthma during exercise, so it's important to diagnose and then manage it.

You might be surprised when you are asked about allergies. Parents sometimes forget that allergies can put your child at risk during sports. How so? Allergies to insects and bees can be a real problem for sports played outside during warm weather, and the ubiquitous team snack afterward can expose children to food they’re allergic to. So it is critical to know upfront if your child has allergies.

Many parents have heard stories about a young athlete who suddenly dies of cardiac arrest on the basketball court or baseball field. This often is a result of a condition called hypertrophic cardiomyopathy (HCM). Despite some news coverage, HCM is fairly uncommon, although there often is a strong family history. You and your child will be asked about any chest discomfort, murmurs, shortness of breath or dizziness, or feeling like passing out. (In the absence of a family history or a physical exam finding, EKGs and echocardiograms are not routinely done as part of this exam.)

This exam is a good time to talk about the role of supplements as well as performance-enhancing drugs, which teenagers sometimes use. Such supplements and drugs often have significant side effects and should never be used without a doctor’s guidance.

Although getting ready for school to start can be quite hectic, try to schedule the pre-participation exam at least 4 to 6 weeks before an activity is scheduled to begin, just in case lab tests or imaging studies need to be done, which then might require a visit to a specialist.

Questions? Comments? Email me at [email protected].

Find more articles, browse back issues, and read the current issue of WebMD Magazine.

PrEP prevents HIV — so why aren’t more people taking it? - Harvard Health Blog

Each year, 1.7 million people globally are newly infected with HIV — more than 38,000 in the United States alone. This year, President Trump announced a 10-year initiative aimed at reducing new HIV infections in the US, and ultimately ending an epidemic that has plagued this country, and the world, since HIV first emerged in the early 1980s. A key part of that plan is pre-exposure prophylaxis or PrEP, a daily medication to help prevent HIV that is recommended for people at high risk. Recently, the FDA approved a new formulation of PrEP for many — but not all — of those at risk.

What is PrEP and who should consider it?

PrEP is a daily pill taken to lower a person’s risk for getting HIV. It works best as part of a program of preventive services that includes regular HIV testing.

Global research during the past decade shows that a combination of two antiretroviral medicines is more than 90% effective at preventing HIV. These medicines, emtricitabine and tenofovir disoproxil fumarate, are known by the brand name Truvada. Along with other medicines, they are also used to treat HIV.

The Centers for Disease Control and Prevention (CDC) and many expert guidelines recommend PrEP for those at high risk for HIV, including

  • men who have sex with men
  • heterosexual men and women who have high-risk exposure (such as having a partner with known HIV infection, exchanging sex for drugs or money, or having sex with a person at high risk for HIV)
  • people who inject drugs
  • transgender women.

Currently, 50% of new HIV cases in the US occur among Black and Latino gay and bisexual men. Slightly more than 15% occur among heterosexual women, roughly three-quarters of whom are women of color.

The CDC estimates that 1.1 million people in the US would benefit from PrEP, including 175,000 women and 780,000 people of color. Yet prescriptions for PrEP are sluggish, particularly in populations at increased risk. Since 2012, only 135,000 PrEP prescriptions have been filled in the US. Almost all were for men — largely, white men in the Northeast and on the West Coast who have sex with men.

The new formulation of PrEP

In August, an FDA advisory panel voted 16 to 2 to recommend a new formulation of PrEP for men who have sex with men and transgender women, while voting 8 to 10 against approval in cisgender women. The panel was presented with data from a single study sponsored by Gilead, the manufacturer of the drug, which is a combination of emtricitabine and tenofovir alafenamide (brand name Descovy). This new formulation is less likely to affect the kidneys and bones, yet is just as effective as Truvada in preventing HIV.

The DISCOVER trial enrolled 5,387 participants across 92 study sites. Nearly all were cisgender men. Less than 10% of the study participants were Black. Only 74 transgender women were enrolled, and the study explicitly excluded cisgender women.

The FDA panel members acknowledged these limitations. Dr. Lindsey Baden, an infectious disease physician at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, noted “we’ve failed women,” and Dr. Roblena Walker, a consumer representative on the panel, voted against approval, citing the poor representation of Black men in the study, calling this “a lost opportunity to provide substantial data reflective of the community that is impacted by HIV.”

How else might the 10-year initiative help?

Four key strategies are emphasized in the 10-year initiative and backed by the global research community:

  • Increase access to HIV testing, and ensure that all people living with HIV know their diagnosis.
  • Expand access to effective treatment to get people on medication and virally suppressed, which helps prevent HIV transmission.
  • Respond quickly to sites of potential HIV outbreaks and populations at increased risk.
  • Prevent those at risk for HIV from becoming infected.

The bottom line

The fact is that PrEP works. Studies in men, women, and people who inject drugs have repeatedly demonstrated substantial decreases in HIV incidence after PrEP programs are rolled out. So if you’re concerned about your risk for HIV, talk to your doctor about taking PrEP or find a provider near you. If you’ve tried PrEP, but had trouble taking it regularly, discuss those issues with your provider, too.

Given the low numbers of PrEP prescriptions, we should encourage anyone who might benefit from PrEP to consider taking it. Globally, estimates suggest less than 350,000 people are on the medication, far short of the World Health Organization goal of three million PrEP users by 2020. We can lobby for additional investment in PrEP programs, innovative implementation projects, and clinical trials for new drug development. And we can insist that those investments reflect the nearly 800,000 new global infections in women and the racial disparities in HIV diagnoses that persist in the US.

We can, and we must, push for broader access to PrEP and clinical trials that enroll all of those at risk for HIV. We cannot settle for the status quo that has seen continued spread of the virus. As individuals and as a community, we can, and we must, act now to truly end this epidemic.

Related Information: Harvard Health Letter

Are Personalized Diets Ready for Prime Time?

Sept. 19, 2019 -- When Howard Wolinsky was diagnosed with type 2 diabetes, he expected to kiss bagels goodbye -- too many carbs. But a personalized diet based on his own gut microbiome offered a pleasant surprise: “It turns out those little bugs in my guts seem to like bread, if it’s combined with fats and proteins,” he says.

Wolinsky’s diet came from DayTwo, a company that uses research from the Weizmann Institute of Science in Israel to create customized advice for people with diabetes. From his home in suburban Chicago, Wolinsky, 71, sent the company a stool sample and a completed questionnaire, and he got back guidance about precisely which foods would spike his blood glucose and which would keep it steady. He was also taking an oral medication for his diabetes.

“I could have a bagel, with cream cheese and lox,” he says. “That combination got a really good rating on the DayTwo scale.” He was amazed to find that when he followed DayTwo’s advice, his blood sugar remained within a normal range. It didn’t spike the way it would for foods outside their recommendations.

DayTwo has plenty of company in the personalized diet business. At least a dozen outfits offer nutrition advice customized to your body, based on DNA or blood tests, microbiome profiling, or a combination of those. Several promise weight loss, while others focus on specific conditions or just general “wellness.” Each uses its own proprietary process, and for some, the science behind it gets murky. Costs range from under $100 to nearly $1,000 for different services. DayTwo, for example, charges $499 for a microbiome testing kit, personalized app, orientation call with a registered dietitian, and microbiome summary report.

Earlier this year, a new study about personalized diets made headlines. Called the Predict Study, it found that different people respond to exactly the same food in different ways -- even identical twins, who have almost the same genetic makeup. So, a muffin that spikes one person’s blood glucose might not affect someone else’s. The study captured data by closely monitoring how 1,100 people, more than half of them twins, responded to various foods, including prepared items provided to them. Researchers tracked details like blood sugar, insulin, and triglycerides (fat) as well as sleep patterns, activity levels, and gut bacteria. Using that data, they began to create a model to predict how anyone might respond to a particular food, based on their own microbiome and DNA.

At this point, none of the personalized diets on the market gather enough information about you to pinpoint what you should eat for overall health -- you’ll only get a partial picture. And there’s no consensus about what they should be gathering.

“I find the genetic factors and the microbiome effects too confusing at this point to make any solid recommendations,” says Schwarcz. “People are putting the cart before the horse.”

Everything You Need To Know About Polycystic Ovaries

Irregular periods, weight gain, anxiety, acne, oily skin, excessive or thinning hair… These are all common symptoms of polycystic ovaries. Yet despite the fact that one in ten women have polycystic ovary syndrome (PCOS), it still remains misdiagnosed due to this long list of symptoms. All of which, are extremely common (or you may not have any symptoms) and, therefore, prevent doctors from connecting the dots and landing at the correct diagnosis.

In fact, it’s estimated that 4-12% of women (who are of childbearing age) suffer from PCOS, which in itself is a confusing statistic! The grey area between 4-12% is because that 8% of women are unaware of their condition. So, as it’s PCOS awareness month, we thought there’s no better time to tell you everything you need to know about PCOS.

For the hormonal 411, we got in touch with Dr. Sherry A. Ross, Women’s Health Expert and Author of She-ology: The Definitive Guide to Women’s Intimate Health. Period., who gave us an outline of what PCOS is and some of the most common symptoms and how to treat them.

What Are Polycystic Ovaries?

PCOS is a hormonal disorder that occurs among women who are of reproductive age (after your first period) when your hormone levels are out of balance. As a result of this imbalance, it can cause many small, fluid-filled sacs to grow inside the ovaries. The word “polycystic” actually means “many cysts.”

The ovary on the left shows the cycle of regular follicles while the ovary on the right has cysts.

What Causes Polycystic Ovaries?

If you’re wondering what causes this imbalance, Dr. Ross says that “No one really knows the cause of PCOS.” However, she assures us what is known, are the effects of the two hormones involved: insulin and androgen. She explained: “There are increases in hormones called androgens and resistance to another hormone called insulin. High androgen levels, mainly testosterone, cause symptoms such as unwanted hair growth all over the body, oily skin, and acne. The hormone insulin controls the sugar or glucose levels in our blood. Therefore, higher blood levels of insulin cause you to feel hungrier which can lead to weight gain and obesity. In women with PCOS, estrogen levels tend to be in the normal range while testosterone is in a higher range than most women.”

via Giphy

Signs and Symptoms of Polycystic Ovaries

“The long list of symptoms associated with PCOS include irregular periods, excessive hair growth, obesity, oily skin, acne, infertility, depression and anxiety, male-pattern baldness or thinning hair and infertility, all of which are physically and emotionally disruptive,” Dr. Ross told us.

It’s also possible to have one or multiple symptoms, which again explains why it’s often overlooked and misdiagnosed. For example, you may have oily skin yet not experience hair thinning, therefore you wouldn’t automatically assume, nor would a dermatologist, that it was a symptom of PCOS. If you do suspect you have PCOS, begin to log the various symptoms that you’re experiencing and present them to your OBGYN. Your doctor will then conduct a pelvic examination or do a pelvic ultrasound to determine if you have polycystic ovaries.

How To Treat Polycystic Ovaries

While Dr. Ross says “There’s no cure for PCOS” you can treat each symptom individually, however, this depends on “how disruptive and annoying each one is in your life and daily routine.” We realize that each symptom is accompanied by its own difficulties, which is why Dr. Ross says; “It’s best to include a knowledgeable team of experts, including a gynecologist and nutritionist to help navigate your diagnosis and all the disruption it can cause. The good news is there are great treatments to control the symptoms caused by PCOS and adapting certain lifestyle behaviors to help avoid some of the long term medical diseases.” Here’s a quick breakdown of the PCOS symptoms and the various treatment options:

PCOS Symptom No#1: Irregular Periods

via Giphy

Dr. Ross tells us that one of the most common symptoms is irregular and ‘troublesome periods.’ To counteract this, she tells us “Hormones, including the birth control pill or progesterone, are used to regulate and balance out your periods. Long-acting reversible contraceptives [semi-permanent contracption] include Depo-Provera, Norplant arm implants and intrauterine devices (IUDs), and are frequently used to control erratic bleeding.”

PCOS Symptom No#2: Unwanted Hair Growth or Hair Loss

There are plenty of treatments to combat unwanted hair growth or on the other side of the spectrum, things you can do to help prevent hair loss. We would know, we’ve tried them all, from laser hair removal to hair vitamins. Dr. Sherry recommends “Spironolactone, which is a medication used to help control excessive hair growth, and “the birth control pill is also helpful to treat unwanted hair,” however, these can also be helpful for treating hair loss from PCOS. If you prefer not to take any medication that could help reduce hair growth, then laser hair removal is a good permanent solution, and there are even at-home laser removal devices.

If either hair loss or hair growth is affecting you, you should discuss with your doctor the best method of treatment.

PCOS Symptom No#3: Increased Hunger 

via Giphy

According to Dr. Ross, “Many women with PCOS have a challenging time losing weight and tend to be overweight,” due to high insulin levels, which result in increased hunger. Yet one of the most impactful treatments of PCOS is a healthy eating regime, that can help control your insulin levels, and therefore other symptoms may subside. Dr. Ross says “Controlling your weight helps control irregular periods, excess hair growth and acne,” and that “seeing a nutritionist is often the best approach to making successful food choices and achieving weight loss. Eating foods that are plant-based, nutrient-rich, fresh and unprocessed along with healthy fats is an ideal diet focusing on a lifelong diet strategy.”

PCOS Symptom No#4: Oily or Acne-Prone Skin 

via Giphy

As our skin is hugely impacted by our hormones, the imbalance can result in acne-prone or oily skin. If acne is a side effect of PCOS, Dr. Ross also suggests some helpful oral treatments such as, “Anti-androgens, antibiotics, and special medicated skin washes are also used to keep the acne under control.” For more details on how your hormones affect your skin read this.

When treating acne or oily skin, it’s also important to ensure your skincare routine is targeted for your skin type. Check out our skincare routine to treat and calm acne-prone skin or our guide for oily skin.

PCOS Symptom No#5: Problems conceiving

Since those with PCOS do not ovulate regularly, Dr. Ross says that “Getting pregnant can be tricky.” However, she assures us “There are a number of medications that you can take to ovulate more regularly. Clomid is the most common medication to get your ovaries ready to cooperate with ovulation and pregnancy. Clomid is given to help you ovulate regularly making the egg available to become fertilized. If Clomid fails, Metformin and gonadotrophins are next on deck to get your ovaries working properly.”

First of all, if you do have any of these symptoms, it doesn’t mean you necessarily have PCOS. However, it might be worth checking in with your gyno so you can either rule out PCOS as a cause of any of the above symptoms (and find appropriate treatment), and if it is PCOS, you can work on a plan to improve the symptoms with your gyno or doctor.

If you’re nervous to go and see your doctor, don’t be. Check out these 9 things your gynecologist wants you to know.

Billions of 'Microplastics' in Each Plastic Teabag

By Steven Reinberg

WEDNESDAY, Sept. 25, 2019 (HealthDay News) -- A new study warns that even your soothing cup of tea might serve up some invisible health hazards.

Some tea companies are replacing traditional paper teabags with plastic ones, but the new bags may be adding of tiny bits of plastic to your beverage, a team from Canada reports.

"We show that steeping a single plastic teabag at brewing temperature [205 degrees Fahrenheit] releases approximately 11.6 billion microplastics and 3.1 billion nanoplastics into a single cup of the beverage," concluded a team led by Nathalie Tufenkji. She's a professor of chemical engineering at McGill University in Montreal.

The global proliferation of microplastics -- bits of plastic so small they are often invisible to the naked eye -- have made headlines recently, having been found in large numbers in ocean and tap water, seafood and even human poop.

"In the past few years, there has been a steadily increasing body of scientific literature demonstrating that not only are microplastics permeating the broader environment, they are entering our bodies, as well," noted Dr. Kenneth Spaeth, chief of occupational and environmental medicine at Northwell Health in Great Neck, N.Y. He wasn't involved in the new research.

Spaeth stressed that there's just too little data on whether or not microplastics pose a threat to human health. However, "based on the molecular composition of microplastics, there is reason to have real concern about the potential health effects," he said, "since they contain a variety of components known to harm human health -- including hormone-disrupting chemicals, as well as human carcinogens."

In the new study, the Montreal team noted that the heat of brewed tea can cause plastic tea bags to break down into bits of plastic that are thousands of times smaller than the diameter of a human hair. That means you can't see, taste or feel them in your mouth.

Investigating further, the researchers removed the tea from plastic teabags sourced from four different manufacturers. They then washed out the empty bags and placed them in hot water.

New medication advances treatment for chronic rhinosinusitis with nasal polyps - Harvard Health Blog

Chronic rhinosinusitis is a long-lasting medical condition, usually caused by infection or exposure to irritants, such as allergies, that affects one in seven American adults. Symptoms include nasal obstruction, nasal congestion, nasal drainage, loss of smell and taste, and facial pain and pressure. Some people with chronic rhinosinusitis also develop additional symptoms, such as asthma and nasal polyps, that are exacerbated by underlying allergies. A nasal polyp is a noncancerous tumor that grows from the lining of the nose or sinuses and affects the drainage system of the sinuses.

While chronic rhinosinusitis is not a life-threatening condition, the chronic nature and progression of the disease can have a significant impact on quality of life, affecting work, productivity, and sleep, and leading to social and emotional consequences, such as depression and anxiety.

Recently, a new medication has been approved in the treatment of chronic rhinosinusitis with nasal polyps.

What is the new medication and how would it be used?

Current treatment includes a combination of therapies that target symptoms. These include medical and surgical treatments, such as antibiotics, short-term oral corticosteroids, steroid nasal sprays, sinus irrigation, and endoscopic sinus surgery. However, many people continue to experience symptoms despite treatment.

Earlier this year, the FDA approved dupilumab (Dupixent) to treat chronic rhinosinusitis with nasal polyps that is not adequately controlled with standard treatment. It is intended to be used together with the other established treatments.

Dupilumab is a human-derived monoclonal antibody, a type of drug that enlists the body’s immune system to help it do its job. It specifically inhibits IL-4 and IL-13 cytokines, chemicals involved in the inflammatory allergic response that leads to symptoms. It is given by injection, under the skin, every other week. It can be administered in a doctor’s office or self-administered at home.

Several clinical trials, including this study published in JAMA (and funded by the drug’s manufacturer), have looked into the effects of dupilumab on chronic rhinosinusitis with nasal polyps. In the JAMA study, participants received either dupilumab plus a steroid nasal spray or a placebo plus a steroid nasal spray, for 16 weeks. Those treated with dupilumab had significant improvements in nasal congestion and obstruction, sense of smell, and overall decreased need for oral corticosteroids and surgery. In those study participants who also had asthma, lung function improved. There were also reductions in nasal polyp size and improved appearance of the sinuses on imaging studies. Patients experienced improvement of symptoms as early as four weeks into treatment, and continued to experience greater improvement than the placebo group for up to one year.

Dupilumab is not a cure for chronic rhinosinusitis with nasal polyps. However, it is an exciting advancement in the treatment of a chronic condition that significantly impacts physical and emotional health.

How do I know if I have chronic rhinosinusitis with nasal polyps and if I am a candidate for dupilumab?

Chronic rhinosinusitis is commonly diagnosed by a primary care physician who can then refer you to an otolaryngologist, or ear, nose, and throat (ENT) physician, for specialty care. The ENT may perform a nasal endoscopy exam and recommend additional testing, such as imaging studies, to make the diagnosis of chronic rhinosinusitis with nasal polyps. Depending on the treatments you have tried, the ENT will assess whether you are an appropriate candidate for dupilumab.

Related Information: Controlling Your Allergies

13 Unexpected Side Effects of Motherhood - Makeup and Beauty Blog

Your friendly neighborhood beauty addict,

Karen

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