Health & Fitness

A class-action lawsuit has been filed against Seattle Children's Hospital after six children died and many others were sickened from Aspergillus mold.¹ The lawsuit claims the hospital knew about "systemic problems" with its air-handling system and the related risks as far back as 2000, but "engaged in a cover-up" that left vulnerable patients exposed to potentially dangerous Aspergillus mold.

Since 2001, Seattle Children's has identified 14 patients who contracted Aspergillus infections during or after hospital stays; six of those patients died as a result.² Attorneys suggest, however, that many more children were likely affected and the numbers could be as high as "dozens if not hundreds."³

As of December 4, 2019, all 14 operating rooms at the hospital's main campus remained closed as a new air handling unit was moved into place.

"We are incredibly sorry for the hurt experienced by these families and regret that recent developments have caused additional grief," Seattle Children's said in a statement. "Out of respect for privacy, we do not intend to share details about our patients or comment on specific cases or legal action."⁴

Hospital's Air Handling System Led to Deadly Mold Infections

Patients affected by the toxic mold at Seattle Children's Hospital range in age from 2 months to 17 years.⁵ The infections occurred from 2001 to 2019 as a result of the hospital's negligence at maintaining and testing its facilities, leading to the transmission of Aspergillus mold spores to hospitalized children, according to the suit.⁶

In 2019, the hospital admitted that it was contaminated with Aspergillus mold since 2001, sickening patients as a result. Air tests conducted in November 2019 also revealed the presence of Aspergillus in several operating rooms.⁷

However, this wasn't a new revelation, as the suit alleges that the hospital knew by at least 2005 its air-handling system could be transmitting Aspergillus, when a family sued them over the issue. "During the course of that lawsuit troubling information surfaced regarding the Defendant's failure to maintain and staff its air-handling systems," the complaint reads.

The lawsuit was settled in 2008 under confidential terms, but the hospital continued to keep "a deadly secret" in assuring patients and the public that it was safe, when in fact the mold persisted.⁸

Further, as early as 2002, an engineering consultant as well as the hospital's lead engineer warned the hospital about "filthy conditions" of its air-handling units, including water leaks, birds in fan shafts, units "rotting out" and failure to test equipment.⁹

The hospital also published an internal investigation in 2007 looking into three Aspergillus infections, but concluded they were isolated incidents. Seattle Children's CEO Dr. Jeff Sperring said in a statement:¹⁰

"As we have previously shared, Seattle Children's has had seven Aspergillus surgical site infections since the summer of 2018. We are deeply saddened that one of those patients died.

As we have looked more closely at our history of Aspergillus infections, we believe there are connections between recent and past infections. Between 2001 and 2014, seven patients developed Aspergillus surgical site infections. Tragically, five of those patients died.

At the time, we believed most of these were isolated infections. However, we now believe that these infections were likely caused by the air handling systems that serve our operating rooms. Looking back, we should have recognized these connections sooner."

Dangers of Aspergillus Infection

Aspergillus is a common type of mold found both indoors and outdoors, in decaying leaves and on plants, trees and compost.¹¹ While most people come in contact with Aspergillus daily without any ill effects, certain strains can be dangerous for people with weakened immune systems or lung diseases.

Disease caused by Aspergillus is known as aspergillosis, which can lead to allergic reactions and infections in the lungs or other organs.¹² The CDC lists seven types of aspergillosis, which range in severity from mild to life threatening:¹³

Allergic broncopulmonary aspergillosis, which occurs when the mold causes allergy symptoms and lung inflammation.	Allergic Aspergillus sinusitis, which occurs when the mold causes sinus inflammation and symptoms of a sinus infection.
Azole-resistant Aspergillus fumigatus, caused by A. fumigatus, a type of Aspergillus that's resistant to certain medications used to treat it.	Aspergilloma, or "fungus ball," which refers to a ball of Aspergillus that grows in the lungs or sinuses.
Chronic pulmonary aspergillosis, which is Aspergillus infection that causes cavities and sometimes fungal balls in the lungs.	Invasive aspergillosis, a serious infection that typically affects people with weakened immune systems; it commonly affects the lungs but may spread to other areas.
Cutaneous (skin) aspergillosis, which occurs when the mold enters a wound or other skin break and leads to infection.

Aspergillosis isn't a reportable disease in the U.S., which means numbers on its incidence are scarce, but the CDC estimates that nearly 15,000 aspergillosis-associated hospitalizations occurred in the U.S. in 2014, with costs of $1.2 billion.¹⁴ Further, they noted, "In a broad U.S. health care network of intensive care unit autopsy studies, aspergillosis was one of the top four most common diagnoses that likely lead to death."¹⁵

Aspergillosis Outbreaks in Hospitals

While clusters of cases of dangerous invasive aspergillosis are rare in the general population, outbreaks have occurred previously in hospital settings, particularly among immunocompromised patients.

Recently, lung infections caused by Aspergillus have been reported in people hospitalized with severe influenza and, in one study, invasive pulmonary aspergillosis occurred even in people without a compromised immune system.¹⁶ The CDC also reported:¹⁷

"Although most cases of aspergillosis are sporadic (not part of an outbreak), outbreaks of invasive aspergillosis occasionally occur in hospitalized patients. Invasive aspergillosis outbreaks are often found to be associated with hospital construction or renovation, which can increase the amount of airborne Aspergillus, resulting in respiratory infections or surgical site infections in high-risk patients.

Outbreaks of primary cutaneous aspergillosis and central nervous system aspergillosis in association with the use of contaminated medical devices have also been described. The incubation period for aspergillosis is unclear and likely varies depending on the dose of Aspergillus and the host immune response."

While it's virtually impossible to avoid exposure to aspergillus in the environment, hospitals have a responsibility to ensure they aren't exposing patients to this potentially dangerous fungus via an ill-maintained air handling system. As for Seattle Children's, they're installing new air handlers in an attempt to resolve the mold issues:¹⁸

"Seattle Children's will install a new rooftop air handler as well as custom-built, in-room high-efficiency particulate air (HEPA) filters in every operating room and adjacent supply area. HEPA is an extremely effective filtration system that removes 99.97 percent of particles from the air that passes through the filter.

This is the highest level of filtration found in operating rooms today. These operating rooms will remain closed until the enhancements are fully in place."

Is There Mold in Your Home?

Common health problems that can be attributed to poor and potentially toxic indoor air quality courtesy of mold growth include but are not limited to the following. If you have any of these issues, it may be worthwhile to consider your indoor air quality, and the possibility that your health problems may be related to mold.

Frequent headaches	Depression	Chronic fatigue
Allergies	Neurological problems; poor concentration and forgetfulness	Skin rashes
Stomach and digestive problems, such as dysbiosis, leaky gut and frequent diarrhea	Chronic sinusitis	Joint aches and pains
Muscle wasting	Frequent fevers	Asthma or trouble breathing

To determine if mold is lurking in your home, first look for signs of visible mold or musty odors. However, not all mold is easily detectable, so if you can't see any visible traces of mold, take an air sample and use a moisture meter to determine the moisture level in the area.

Wood flooring should have a maximum moisture content of 10% to 12%, for instance, as anything above that is a breeding ground for mold. Exterior walls should not have a moisture content above 15%. In addition to air sampling, proper lab testing of bulk samples of the mold growth is recommended.

This will require cutting out a piece of the affected area. The U.S. EPA has a test called Environmental Relative Moldiness Index (ERMI), which tests for 31 different species of mold. If all you have is a small area of surface mold, you probably don't have to call in an expert. However, only attempt to clean it if it's limited to the surface of a small area. Any deep-rooted mold will require professional assistance to remediate.

Mold Is Serious, Here's What You Can Do

Aspergillosis is an example of what Dr. Ritchie Shoemaker calls biotoxic illness. Most biotoxic illnesses are difficult to diagnose and treat as all of them, including mold, affect multiple systems in your body and produce a wide array of symptoms.

Shoemaker, a pioneer in the field of biotoxin-related illness, explains that the underlying commonality, whether the disease is caused by dinoflagellates, mold or spirochetes, for example, is chronic inflammation. The inflammation induced by exposure to the toxins and metabolic products produced by these microorganisms is what wreaks havoc on your health.

"In order to treat them, we need to both remove them from exposure and remove toxin from their body," Shoemaker said. Many of his patients have had success using cholestyramine (CSM), a rarely used cholesterol drug that binds to not just cholesterol, but just about everything of a particular molecular shape and size.

"Binding CSM to the toxin prevents its reabsorption. There's another cholesterol-lowering resin called Welchol that also has these net positive charges … Even though people have used clays — and Bentonite is one — with some success, cholestyramine is so much better that people would put up with the common side effects of constipation and some reflux," he said.

This is only the first step in his protocol, which includes 10 additional steps intended to stop the inflammatory process initiated by the mold (or other toxin) exposure. For more information, SurvivingMold.com is a great resource for medical practitioners and patients alike.¹⁹

I also discuss helpful tests and diagnostic tools for mold-related illness in "Mold: The Common Toxin That Can Be Far More Damaging Than Heavy Metals." Overall, your best approach is to find a well-informed physician with expertise in environmental medicine. Together you can devise an appropriate treatment plan. For a list of physicians with experience in treating mold-associated disease, see DrThrasher.org.

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Your entire body takes direction from your hormones. Hormones are secreted by your endocrine system and are responsible for telling your organs what to do and when to do it.¹ They are essentially chemical messengers that travel throughout your bloodstream, working slowly over time to affect processes like growth and development, metabolism and reproduction.

Sometimes, these chemical messengers may get out of balance, and this leads to chronic disorders such as Type 2 diabetes, weak bones and infertility.² Hormones may be secreted by your adrenal glands, endocrine-related organs, hypothalamus, sex glands and other organs.³

Progesterone is important to fertility and supporting a pregnancy. It’s a steroid hormone secreted by the corpus luteum and then by the placenta if you become pregnant.⁴ In some cases, when couples suffer from infertility, they choose in vitro fertilization (IVF).

This is a complex series of procedures in which eggs are retrieved from the ovaries, fertilized by sperm in a lab and then transferred into the uterus.⁵ One full cycle can take up to three weeks⁶ and cost $12,000.⁷ In response to her struggles with infertility, Amy Galliher-Beckley, Ph.D.,⁸ co-founded MFB Fertility and the progesterone test Proov.⁹

The Estrogen and Progesterone Relationship

Each of your bodily systems maintains a balance to help you maintain optimal health. Your reproductive system is no different. For a woman, there are several hormones affecting a complex system to mature an egg follicle and release an egg where it travels to the uterus. If fertilized, the egg must implant into the uterus, called the endometrium, where it begins to develop into a baby.

These events are controlled by hormones secreted from several sources in the body. The ovaries produce the eggs and are the main source of estrogen. The adrenal glands sit on top of each kidney and also make a small amount. Estrogen plays a role in physical changes during puberty; it also controls the menstrual cycle, protects bone health and affects your mood.¹⁰

The second hormone essential to fertility is progesterone, a steroid hormone that is first secreted by the corpus luteum. After the egg is released, the corpus luteum is left attached to the ovary, which functions as a temporary gland.¹¹ These two hormones are controlled by the release of other hormones.

During the menstrual cycle gonadotropin-releasing hormone is secreted from the hypothalamus, triggering the secretion of follicle-stimulating hormone (FSH) from the pituitary gland.¹² This begins follicle development and triggers a rise in estrogen.

Luteinizing hormone (LH), also secreted by the pituitary gland, supports the maturation of the follicle and a trigger to cause the egg to be released. When estrogen levels get sufficiently high it signals a sudden release of LH, around mid-cycle, which triggers a set of events that ultimately release the mature egg from the follicle.¹³

Once released, the empty follicle becomes the corpus luteum, which produces progesterone. The release of progesterone triggers the uterus to develop a highly vascularized bed suitable for implantation of a fertilized egg.

Without fertilization, the corpus luteum begins to degenerate, the secretion of progesterone drops off and menstruation occurs. If pregnancy occurs then the corpus luteum produces progesterone for the first 10 weeks until production is taken over by the placenta.^14,15

Not About Getting Pregnant, but Staying Pregnant

As Beckley explains in her interview with Forbes magazine,¹⁶ her test is not about getting pregnant, but rather staying pregnant. Progesterone not only prepares the uterus for the egg to implant; it also protects the endometrium from degeneration and menstruation. While the body is producing high levels of progesterone during a pregnancy, a second egg will not mature.¹⁷

In order to maintain a pregnancy, the corpus luteum must continue to secrete progesterone. This maintains the blood vessels in the endometrium to feed the growing baby. It is in these early weeks that women with low levels of progesterone may have difficulty, both conceiving and developing the right environment for a fertilized egg to grow.

Some women who do get pregnant are at a high risk for miscarriage.¹⁸ The test Beckley developed comes with sticks used in much the same way ovulation and pregnancy tests are used. These sticks measure the amount of progesterone metabolites excreted in the urine. To date, this is the first at-home, over-the-counter test used to evaluate a woman's ability to produce progesterone.¹⁹ Beckley explains:²⁰

"Low progesterone is the number one cause of unexplained infertility. Women who go through IVF protocols all are offered progesterone. If you are not going through IVF, most doctors don't talk about progesterone, they don't offer progesterone, they don't test for progesterone. When your progesterone crashes too quickly, it is called a luteal phase defect."

Luteal Phase Defect Increases Chances of Miscarriage

The luteal phase in a woman's cycle begins after ovulation and represents the second half of the menstrual cycle. The luteal phase is named after the corpus luteum. Luteal Phase Defect (LPD) results in an abnormal endometrial growth that may not support a pregnancy.^21,22

While researchers struggle to identify the underlying dysfunction and efficacy of LPD in supporting fertility, experts report women undergoing IVF always have LPD present.²³ LPD is marked with a luteal phase less than 11 days. However, not all physicians believe the condition exists; reliable tests are lacking.²⁴

Beckley developed the Proov urine test to help women identify a reduction in progesterone during their cycle. According to Beckley,²⁵ her test gives women more knowledge about how their body works and provides a foundation for asking their infertility doctors better questions.

The test measures the presence of metabolites in the urine that should increase and remain elevated after ovulation. It may be used to confirm ovulation and confirm levels of progesterone afterward. A single negative test before ovulation followed by a single positive test will confirm ovulation for women trying to get pregnant.²⁶

For women trying to conceive, the test is recommended four days after peak fertility and then for continued testing 10 days past ovulation.²⁷ When questions arise about levels of progesterone to maintain a pregnancy, they recommend testing six days after peak fertility and as needed during the pregnancy since the test should remain positive.

Other Functions of Progesterone

Although LPD has a significant impact on a woman's ability to carry a pregnancy, it is the subject of debate.²⁸ In some cases, the ovaries release enough progesterone but the uterine lining does not respond.²⁹ LPD has been linked to other health conditions, including:³⁰

Anorexia	Endometriosis
High levels of exercise	Obesity
Thyroid disorders	Polycystic ovary syndrome (PCOS)
High levels of prolactinemia (the hormone responsible for breast milk)

In some circumstances, when these conditions are treated, the LPD resolves.³¹ Later in life, if levels of progesterone decline, a woman’s period may become irregular, heavier and longer,³² increasing her chance of experiencing anemia, depending on the amount and length of her period.³³

Variations in hormone levels after menopause may also influence cognition and mood.³⁴ In a study of 643 healthy postmenopausal women, researchers found that while estrogen had little effect on tests of executive function or global cognition, progesterone concentrations were associated with verbal memory. The researchers suggest this positive association merits additional study.

Bioidentical progesterone, also known as micronized progesterone in the oral form, has been successful in helping relieve hot flashes and night sweats during menopause. Dr. Jerilynn Prior from the University of British Columbia Vancouver presented her study at an endocrine society meeting during which she compared the use of progesterone to placebo.³⁵

The study assigned 114 postmenopausal women into one of two groups, a placebo group and another who took 300 mg of micronized oral progesterone daily. To be eligible for the study, the women had to be off hormone therapy for at least six months.³⁶

At the end of the 12-week study, researchers found that the group taking micronized progesterone demonstrated a 56% decrease in a score reflecting the number and intensity of symptoms, while the women taking the placebo reported a 28% decrease.³⁷

Age Does Affect Hormone Balance

As is borne out by the number of women struggling with hormonal imbalances as they age and those requiring fertility assistance to become pregnant after 40,³⁸ Beckley is vocal about the difficulty women may have supporting a pregnancy after she turns 40.³⁹

Beckley says,⁴⁰ “The closer a woman gets to menopause, the least likely her body is going to be able to support a pregnancy.” Much of this is related to the imbalance of hormones required to successfully support a pregnancy that occurs as women age.

Her research in designing the progesterone urine test led Beckley to believe 30% to 40% of women who undergo IVF treatment to become pregnant ultimately do not need IVF.⁴¹ Instead, they may require progesterone to develop a healthy endometrial lining and support early pregnancy.

Overall Fertility Is on the Decline

Couples experience infertility for a number of reasons. In a study⁴² released in 2017, researchers evaluated 38 years of information and found sperm counts declined significantly between 1973 and 2011. The sperm counts declined 52% to 59% in men located in North America, Europe and Australia.

The Australian Department of Health reports 1 in every 6 Australian couples suffers from fertility problems, which they attribute to the decision to have children later in life as well as declining sperm count. Quality and lifestyle factors such as smoking, not eating healthfully, consuming excessive amounts of alcohol and not having a healthy BMI also affect fertility.⁴³

In May 2019, the Pew Research Center reported that for the fourth year in a row, key fertility indicators for U.S. couples declined, reaching a record low.⁴⁴ Two of the three indicators used to determine fertility reflected a decline in numbers.

The total fertility rate, or the estimation of the number of children a woman would have in her lifetime, was 1.73 children in 2018. This was lower than the estimate of 1.74 from the mid-1970s.⁴⁵

Research suggests men’s fertility is affected by environmental toxins and chemicals you may find in your own home, which I discuss in a past article, “50 Percent Fertility Reduction Because of These Household Chemicals.”

Additionally, as described in the past article, “Birth Rate Reaches Record Low as Premature Deliveries Rise,” statistics from the CDC show the number of new births was down 2% in 2018 as compared to 2017, but the number of premature births was rising. Infertility and pregnancy are complex conditions that likely need a comprehensive approach to experience a successful outcome.

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Quitting smoking is likely one of the best things you can do for your health as traditional cigarettes cause damage to nearly every organ in your body. Vaping, or using e-cigarettes, is sometimes marketed as a way for adults to quit smoking, but there's not enough evidence to demonstrate it helps.¹

If you're trying to quit smoking, the American Heart Association² endorses using established methods. They suggest you don't try vaping because you think it's “cool” or “safe.” There is a perceived assurance e-cigs are safe and harmless. The vapor is often the odorless, making it difficult to detect once the device has been put away.

In a 2016 report,³ "E-Cigarette Use Among Youth and Young Adults," the U.S. Surgeon General called the products unsafe and documented an alarming increase in use by young adults. The report also showed e-cigarettes are associated with the use of other tobacco products as well as challenges with brain development affecting the health and mental health of young adults.

In July 2018 the Verge reported⁴ on the difference between Juul salts using freebase nicotine and other e-cigarettes. The combination of freebase nicotine with benzoic acid creates a chemical reaction designed to be as easy to inhale as cigarettes. A company spokesperson, Victoria Davis, called fighting underage vaping a “top priority.” She said:⁵

“Juul is intended for adult smokers only who want to switch from combustible cigarettes. We cannot be more emphatic on this point: No young person or non-nicotine user should ever try Juul.”

Juul spends thousands in schools and camps

Davis’ commentary in 2018 does not line up with information presented to the House Oversight Subcommittee on Economic and Consumer Policy, which viewed documents as part of an investigation into the role the company played in the vaping epidemic.⁶

Documents show “Juul spent hundreds of thousands of dollars to fund” programs, which an employee characterized as⁷ "our new understanding of how much our efforts seem to duplicate those of big tobacco." In the same email thread, another employee expressed concerns about pulling out of the health fair as they would certainly lose the school as part of the pilot program.⁸

In a memo from the Subcommittee,⁹ an examination of the role Juul has played in teenage nicotine addiction was outlined. The memo stated Juul had deployed “a sophisticated program to enter schools” and direct its message at teenage children; it also targeted teenagers in summer camps and public out of school programs.

Internally,¹⁰ Juul maintained a division aimed at recruiting schools to present a program to students. In testimony about one presentation, a representative from Parents Against Vaping E-cigarettes said no parents or teachers were allowed in the room and the message from the company was the product was safe. During the presentation, the presenter did a demonstration of how to use the product.

The program paid the school system $10,000 to access the students in class, in summer school or at a Saturday school program.¹¹ Additionally, they targeted teenagers by purchasing access to teens in a public out of school program,¹² in one instance paying the Richmond, California, Police Activities League $89,000 to offer the Juul program.

At another time, the company paid $134,000 for access to children attending a five-week summer camp, recruiting those in grades 3 through 12 and providing them with a “holistic health education program.”¹³

Juul also engaged social media influencers

Over the past decade, there has been a shift from celebrities to social media influencers behind the drive to purchase new beauty products, cars and clothing and to get involved in nonprofit organizations. Whereas before spokespeople have been recognizable celebrities, marketing companies now understand the power that social media influencers wield on personal brand recognition.¹⁴

Audiences appear to be more receptive to social media influencers who often are the first to try products and services.¹⁵ In one survey 70% of brand marketing agencies said they either “agreed” or “strongly agreed” their 2018 budgets aimed at social media influencers would increase; 89% thought this form of marketing could impact how people felt about their product.¹⁶

Juul was no exception. They put into place a sophisticated program used to promote their product online to young people.¹⁷ Documents obtained by the subcommittee show Juul hired the Grit Creative Group to find 280 influencers in the Los Angeles and New York area¹⁸ “to seed Juul product to over the course of three months.”

In a second contract with the same company, Juul sought to secure social media influencers who held a following of at least 30,000 to attend launch events and engage their efforts to establish a network to leverage their influence for the company. Just four months later, the company's marketing update stated:¹⁹

“The Container Tour will get JUUL into the hands of over 12,500 influencers, subsequently introducing JUUL to over 1.5 million people.”

The subcommittee was given further evidence of the program designed by Juul with planning documentation, in an email showing an employee held the title “Influencer Manager” and another email indicating there may be an entire department devoted to addressing social media influencers within Juul.²⁰

Company pushes addictive nicotine but tells teens it’s safe

The subcommittee met in late July 2019,²¹ hearing testimony from research experts, parents and Juul Labs. In addition, the subcommittee heard testimony from two teenagers who told Congress a Juul representative had repeatedly told their ninth-grade classroom the e-cigarette was totally safe and then went on to show the students the device. All the students were underage.²²

One of the teens, 17-year-old Caleb Mintz, told Congress the representative was there as part of a mental health seminar during which teachers were not present. At just 17, Mintz cut to the chase on Juul’s marketing tactics when he said:²³

"I believe the presenter was sending mixed messages by saying Juul was 'totally safe' and following up every totally safe statement with 'but we don't want you as customers.’ I believe that the presenter was playing on the rebellious side of teens, where when teens are told not to do something, they are more likely to do it."

Following Mintz’s testimony, his 16-year-old friend Philip Fuhrman testified. CNN reported Fuhrman told Congress the Juul representative told him the²⁴

“FDA was about to come out and say that Juul was 99% safer than cigarettes, and he said that that would happen very soon, and that it was in FDA approval while the talk was going on.”

In June 2018, Juul Labs was valued at $15 billion.²⁵ While selling tobacco and nicotine to those addicted has been a good business model, Juul innovated the e-cigarette to a product delivering more nicotine than a cigarette and with a sensation similar to smoking. This is all thanks to nicotine salts, a chemical base used to deliver nicotine.²⁶

Each puff from a Juul delivers more nicotine than other e-cigarettes while reducing throat discomfort at higher concentrations. And, because nicotine salts work well in smaller devices, there's no need to opt for a larger, bulkier e-cigarette product. Using new technology, Juul salts in one cartridge delivers roughly the amount of nicotine as found in a pack of cigarettes.²⁷

The vaping community acknowledges nicotine salts are potentially more addictive since they lead to higher blood levels of nicotine over a short amount of time.²⁸ Juul sponsored a study demonstrating their²⁹ "tobacco-flavored nicotine salt-based ENDS were well tolerated and provided similar nicotine exposure and perceptual satisfaction compared to tobacco-flavored combusted cigarettes.”

Reactions in vape juice form airway irritating compounds

The long-term effects of heating e-cigarette juice have not been determined, but researchers have now found these liquids are reacting on the shelf and forming chemicals called acetyls. In a study published in Nicotine and Tobacco Research,³⁰ data show the liquids may form new chemicals as they are sitting on the shelf with unexpected toxicological effects.

The researchers recommended a rigorous process to monitor the changes in chemical composition and continue to analyze the situation in order to identify the potential health hazards to users. In other words, chemical reactions that occur once the liquid is placed in the delivery device and before heating, may increase the potential risk for those using e-cigarettes.³¹

The chemicals in question are from flavorings for vanilla, cherry, citrus and cinnamon. Sven-Eric Jordt, Ph.D., from Duke University, and senior author of the study commented on the results, saying:³²

"These individual ingredients are combining to form more complex chemicals that are not disclosed to the user. When inhaled, these compounds will persist in the body for some time, activating irritant pathways. Over time, this mild irritation could cause an inflammatory response."

Clusters of seizures and pulmonary infections

Doctors and hospitals have found vaping is associated with a cluster of neurological conditions.³³ The FDA has received reports of 127 people who have experienced seizures or other neurological symptoms potentially related to the use of e-cigarettes. Although experts have not yet established a link, they are investigating if the nicotine in e-cigarettes are causing neurological disturbances.

NPR reports³⁴ there have been 15 cases of severe respiratory injury in Wisconsin and 15 more are suspected. Six other cases were reported in Illinois and four in Minnesota, prompting the Centers for Disease Control and Prevention to work with health departments to determine the cause.

The problem was first found by Children's Hospital of Wisconsin after eight healthy teenagers were hospitalized with rapid onsets of coughing, weight loss and breathing difficulties. Some were admitted to the Intensive Care Unit for treatment. At this point, Dr. Thomas Haupt from the Wisconsin Department of Health Services says the only common denominator has been vaping.³⁵

Vaping companies sue over regulations to protect kids

In 2009, the law gave the FDA power over combustible cigarettes but not e-cigarettes. In 2016 the agency expanded those regulations but have repeatedly delayed the timeline to review the products that have come to market. Recently, an e-cigarette industry group sued to delay the review arguing the deadline of May 2020 could wipe out many smaller companies.³⁶

Unfortunately, while manufacturers and regulators argue over legalities, children and teens are being caught in the middle. Exposure at a young age to nicotine affects the reward center in the brain and increases their risk of engaging in addictive behavior as they grow into adulthood.

Additionally, addiction at a young age leaves these teens with no good treatment options for the addiction to a product designed specifically to increase the users risk of becoming addicted. In other words, children as young as 11 are becoming addicted to a product for which medical science has yet to come up with a treatment option safe at their age.

If you are addicted to cigarettes or e-cigarettes and would like to take control of your health and quit the habit, I suggest my previous article, “Quitting Smoking Starts in the Brain,” to learn a free technique that may make the process easier. Take the profit out of the tobacco industry’s pocket and put it back in yours.

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According to the most recent data from the National Health and Nutrition Examination Survey published by the Centers for Disease Control and Prevention,¹ 39.8% of all U.S. adults are obese. The same data show the obesity prevalence in children ages 2 to 19 years is 18.5%, and is expected to rise to 20.6% in adolescents from 12 to 19 years.²

According to the National Institute of Diabetes and Digestive and Kidney Diseases,³ an individual who weighs more than what's considered normal for their height is described as overweight or obese. According to the CDC, the percentage of youth who are overweight or obese has more than tripled since the 1970s.⁴

There are several factors contributing to these rising percentages, including shorter sleep duration, metabolic inefficiency, poor eating and low levels of physical activity.⁵ Children who are obese are also more likely to develop health conditions such as metabolic syndrome, musculoskeletal disorders, cardiovascular disease and disability.⁶

The growing number of those who are overweight and obese directly feeds the weight loss industry, which market researchers anticipated would grow in 2018 to a value of $70.3 billion.⁷

While the final reports are not yet out on whether those numbers were actually reached, a summary of Marketdata’s research⁸ showed the greatest gains were expected in the commercial chains and meal replacement programs, with a trend toward ketogenic diets as well as diets high in protein. One market that was identified as untapped and underserved included overweight adolescents.

WW losing consumer base opens up to teens

However, even as researchers anticipated strong growth in the weight loss industry, one iconic company has been posting losses. WW, the company formerly known as Weight Watchers, rebranded their company in September 2018 in an effort to become the world's partner in wellness. According to Mindy Grossman, president and chief executive officer:⁹

“No matter what your goal is — to lose weight, eat healthier, move more, develop a positive mind-set, or all of the above — we will deliver science-based solutions that fit into people's lives. This is just the beginning of our journey to become the world's partner in wellness, and I am inspired by the potential for our impact."

The company posted a poor fourth quarter 2018 performance with declining memberships for 2019. One marketing analyst believes this might be in part due to their rebranding, as well as the declining popularity of “dieting.”¹⁰ Early in 2018, the company offered free membership to teens between ages 13 to 17.

While the company said they were aiming at helping children develop good habits at a critical age, CNN¹¹ reported Weight Watchers expected the tactic to engage young customers who could become loyal for years. The company's goal was to impact 10 million lives with 5 million people in the program by the end of 2020 and another 5 million using other company content.¹²

The announcement angered many parents who felt counting calories and engaging in a weight loss program may give rise to unhealthy eating behaviors. However, Time magazine reports WW CEO Mindy Grossman responded by saying,¹³ “It actually strengthened our resolve and made us offensive.”

The answer didn’t go down well with Lori Ciotti, regional assistant vice president of the Renfrew Center, an organization that bills itself as having treated more than 75,000 adolescents for eating disorders.¹⁴ Ciotti spoke to Today, saying:¹⁵

"Dieting is a slippery slope into an eating disorder. It sends a message that one should not listen to their body's hunger or fullness cues, so it's really concerning from that perspective.

I think what (Weight Watchers) is doing here is offering a sanctioned method of counting calories or points or whatever they want to call it. It's not teaching teens anything about self-care or self-worth. Instead it teaches them that their worth is about a number on a scale or the back of their jeans."

Appearing to aim at childhood obesity, WW lowers the bar

As the company appears to take aim at childhood obesity in their well-publicized “wellness” campaigns, they have now announced the release of a smartphone app for children as young as 8.¹⁶ In their notice, Gary Foster, Ph.D., chief scientific officer at WW said:¹⁷

"At WW, we have decades of expertise in scaling science-backed behavior change programs, uniquely positioning us to be a part of the solution to address the prevalent public health problem of childhood obesity.

Alongside a distinguished group of leaders in pediatric health and nutrition, we've carefully developed this platform to be holistic, rewarding and inspirational so kids, teens and families get the tools and guidance they need to manage their environment and build and sustain healthy habits."

The “distinguished group” to which Foster is likely referring are the scientists at Stanford Pediatric Weight Control Program.¹⁸ The Stanford program was licensed by the app’s founder, Joanna Strober, who helped develop the original app, Kurbo.¹⁹

That app was designed to help children learn healthier eating patterns without parental involvement. This app did not produce metrics like calories, carbs and sugar, but rewarded children for their food choices with a red, yellow or green light. After WW purchased the product, they made a few changes.²⁰

With the WW version, parents have greater involvement, and for an optional monthly subscription, children may work with coaches. Parents also have the option of joining the sessions. WW also added options children can track, such as weight loss, body measurements and Snapchat-style tracking streaks.²¹ Children enter their height, weight, age and goals, and then log what they eat.²²

In an earlier free progra, WW targeted teens aged 13 to 17. But in an effort to take advantage of smartphone applications, children's affinity for using smartphones and the childhood obesity epidemic, WW aimed the Kurbo app at children as young as 8. In their press release, the company says the program:²³

“ … builds on Kurbo's evidence-based mobile platform to help children and teenagers, with support from their families, make lifestyle changes while receiving guidance around sustainable healthy eating, physical activity and mindfulness habits. Kurbo by WW is currently available in the U.S., and the free Kurbo app can be accessed through iOS Apple Store and Google Play.”

Dieting may have the opposite effect

Despite the company's assertion that this is a program that teaches healthy eating choices, critics counter that it’s nothing more than a weight loss program for children, which they believe will contribute to children’s eating disorders. The backlash has gained a substantial following of people filing a Change.org petition calling for WW to remove the app.²⁴

In explaining why she thinks WW’s app is counterintuitive to WW’s stated goals for it, Tomi Akanbi, clinical nutrition coordinator at Mount Sinai Adolescent Health Center, warns that encouraging children and teenagers to count calories like many adults do is dangerous.²⁵ She routinely counsels patients who have adopted weight loss programs used by their parents without realizing that the nutritional needs of teens are different from those in other age groups.

By focusing on calories, many teenagers tend to skip meals or replace foods with empty calories from junk foods. Akanbi goes on to say focusing on weight can also lead to eating disorders, especially in teenage girls who feel pushed by media images to conform to a specific image. Following the announcement of the free summer program for teens, she said to CNBC

“Weight Watchers really is dieting and focusing on just weight, and research has shown when the focus is on weight and dieting in teens, that is not an effective way to promote and sustain weight loss. It’s not even helpful to promote overall wellness because we’re also talking about body image and how these kids are experiencing themselves and food and their bodies, and dieting does not help with that.”

In support of this line of thinking, some experts have suggested weight loss efforts in childhood may result in body image dissatisfaction and unhealthy weight control behaviors, including disordered eating, if the behavior is not severe enough to warrant diagnosis of an eating disorder.²⁶

A small study using a survey and two workshops delved into it deeper, with researchers gathering data about how young people interact with fitness mobile apps. The aim was to identify risks and negative experiences about how current fitness apps may or may not exacerbate risky eating behaviors.²⁷

The researchers concluded there was a need for consideration around the design of these apps when used for teenagers who are vulnerable to poor body image and maladaptive eating behaviors.²⁸ Additionally, the American Academy of Pediatrics (AAP) has advised doctors and families to avoid the use of “weight” in their talks with teens and instead focus on healthy lifestyles.²⁹

Calorie counting is not the answer

The AAP stresses families focus on eating a healthy diet and get plenty of physical activity rather than focusing on weight loss, if they want to reduce the risk of their teens developing an eating disorder:³⁰

“Family involvement in treatment of teen obesity and EDs [eating disorders] has been determined to be more effective than an adolescent-only focus. An integrated approach to the prevention of obesity and EDs focuses less on weight and more on healthy family-based lifestyle modifications that can be sustained …

… AAP recommendations include discouraging dieting, skipping of meals or the use of diet pills; promoting a positive body image; encouraging more frequent family meals; and suggesting that families avoid talking about weight.”

The AAP also stressed that making healthy foods such as fruits and vegetables more accessible while limiting sugars and refined carbohydrates is one way to positively address weight without directly talking about it. The pediatricians also suggest working on helping children make lifestyle changes, such as limiting TV and screen time and promoting physical activity — and I agree.

In addition to the possibility that counting calories or counting points may promote an unhealthy relationship with food³¹ and increase a teen’s risk of developing an eating disorder, the act of counting calories is not the answer to maintaining a healthy weight or overall health.

The fatal flaw in counting calories is you don't pay attention to the nutrition you're eating. The calorie-counting theory is that whatever calories you take in, as long as you burn them off, you will either maintain your weight or lose weight. But that way of thinking is simply wrong: All calories are not alike — while you may like to believe 100 calories in an apple and 100 calories in a cookie are identical, they are not.

The real science says that calories you get from whole, unprocessed foods feed your cells and reduce your risk of disease, including obesity. Foods from processed meals include high amounts of sugar or fructose as well as chemicals that may trigger weight gain.³²

Cyclical ketosis supports balanced weight and health

Like the AAP states, more important than counting calories is focusing on bringing home healthy foods and watching where your teens are spending their lunch money. While Grossman has attributed part of the problem with WW’s poor earnings in late 2018 to the keto diet,³³ she’s failed to realize that one reason the keto “diet” — which is aimed at adults — is working is because you don’t count calories. Instead, you focus on eating healthy, which is just what the AAP prescribes.

The good news is that keto also aligns with the AAP’s guidance in that you don’t eat processed foods or refined sugars when you “go keto.” The truth is children need protection from the junk food industry and you can help your children eat healthy and learn to make healthy food choices by simply refusing to buy processed foods, and concentrating on stocking your pantry with organic, fresh fruits and vegetables.

Go the extra step and skip fast food restaurants and cook and eat at home, and you’ll be well on your way to teaching them healthy eating.

You can also help by getting your kids moving. Overweight and obese children need at least 30 minutes of exercise each day, and may benefit from closer to 60 minutes. But, even if your child is not overweight, you should encourage him or her to take part in physically engaging activities after school and on the weekends.

For older teens and young adults who are motivated to try the keto way to health on their own, it’s crucial to understand which fats are good for you and which are not. Most Americans consume harmful fats like processed vegetable oils, which will invariably worsen your health.

So when we're talking about boosting consumption of dietary fats, we're referring to natural, unprocessed fat, found in real foods such as seeds, nuts, butter, olives, avocado and coconut oil. A more extensive list of examples can be found in “Basic Introduction to Metabolic Mitochondrial Therapy.”

If they want to go the next step and consider ketofasting, it’s even more important to remember that this isn’t about skipping meals, but of understanding that cyclical ketosis lies in the metabolic flexibility your body achieves as it is able to burn glucose and ketones for fuel.

Unfortunately, eating over a 12-hour period or more during the day radically increases your risk for obesity as your body is only adapted to burning glucose and it's not flexible enough to burn ketones or fat for fuel.

In addition to metabolic flexibility and the reduction in the risk for metabolic syndrome, cyclical ketosis accelerates autophagy³⁴ during which your body eliminates damaged organelles and intracellular pathogens.³⁵

This essential cleaning process encourages the growth of healthy cells and is a foundation for longevity. Intermittent fasting may be one of the most profound interventions you can do to radically improve your health, increase your body’s ability to preferentially burn visceral fat³⁶ and help you shed excess weight³⁷ all while extending your lifespan.

Instead of picking up the newest smartphone app, consider going on a journey of discovery with your teenagers, seeking out some of your locally grown produce, eliminating the processed foods and incorporating intermittent fasting. Each of these nutritional strategies helps support your overall health and weight control.

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In the U.S., 289,000 children aged 15 years and younger receive a tonsillectomy each year, making it one of the most common surgeries.¹ The procedure completely removes the tonsils and is sometimes performed along with adenoidectomy, which is surgery to remove the adenoids.

While tonsillectomy itself is associated with serious long-term risks,² parents need to be aware that the painkillers given to children following the surgery can also be dangerous. This is especially true if children are prescribed opioids, powerful pain-relieving drugs linked to an epidemic of overdose deaths.

In a revealing study from University of Michigan’s C.S. Mott Children's Hospital researchers, 59.6% of children received a prescription for opioids following tonsillectomy,³ even though safer pain relief options would likely have worked just as well.

Six in 10 children prescribed opioids after tonsillectomy

Data from 15,793 children aged 1 to 18 who underwent tonsillectomy were analyzed for the study, revealing that 6 in 10 had at least one prescription for opioids filled following the procedure. Yet, there was no difference found in risk of return visits for pain or dehydration among children taking opioids or non-opioid drugs.⁴

Taking opioids was associated with an increased risk of constipation and opioid overdose.⁵ What’s more, the median prescription duration was eight days, which could mean an equivalent of 48 doses of the drugs — more than is typically needed. Past research found that an average of 52.2 doses of opioids may be prescribed to children following a tonsillectomy, with an average of 43.8 leftover doses.⁶

Not only does this increase the risk of adverse effects and addiction, but it poses a risk for family and friends who may take the leftover pills.⁷ According to the study authors:⁸

“Most children received less than 50% of their prescribed opioid doses because parents quickly tapered opioids, switched to nonopioids, or discontinued analgesics during the first few postprocedure days.

This left a considerable amount of unused prescribed opioids in the homes of children who were prescribed these agents for acute pain. This suggested mismatch between dispensed and used prescription opioids can inadvertently contribute to risky behavior and, therefore, begs for broad intervention.”

As for why opioids are often prescribed following tonsillectomy, the University of Michigan researchers suggested they’re often believed to provide superior pain relief and reduce the risk of return visits to the doctor, but this study suggests this isn’t the case.

They’re also sometimes offered over nonsteroidal anti-inflammatory drugs (NSAIDs) due to concerns that NSAIDs may increase the risk of bleeding, but research suggests they can be used safely following tonsillectomy.⁹

“Our findings suggest that it may be possible to reduce opioid exposure among children who undergo this common surgery without increasing the risk of complications,” lead author Dr. Kao-Ping Chua said in a news release, adding:¹⁰

“To minimize the risks of opioids to children and their families, clinicians should rely on non-opioids when possible. When opioids are used, they should aim to prescribe only the amount that patients need …

However, our study suggests that many children receive opioid prescriptions after tonsillectomy and that the amount may be excessive. We need to conduct research to identify interventions that safely and effectively reduce opioid exposure for these children.”

Otolaryngologists advise against opioids after tonsillectomy

Prescription opioids are sometimes considered standard care for treating severe pain in adults following surgery or injury or due to illnesses such as cancer, although they’re now increasingly prescribed for many types of pain, including chronic back pain or pain from osteoarthritis.

The American Academy of Otolaryngology-Head and Neck Surgery (AAO HNS), however, advises against their use after tonsillectomy, advising instead, “Clinicians should recommend ibuprofen, acetaminophen or both for pain control after tonsillectomy.”¹¹ In their plain language summary for patients, AAO HNS further states:¹²

“Some medicines like antibiotics and codeine (koh-DEEN) or any medication containing codeine are not good for children younger than 12 years after tonsillectomy. There are better choices than codeine even for children 12 to 18 years old. Codeine [an opioid] can cause very slow breathing and, if too much is given, death. It can also be habit forming (addictive).”

Opioids given to children despite FDA black box warning

In 2012, the FDA announced it was reviewing the safety of codeine use after tonsillectomy and/or adenoidectomy after serious adverse events and deaths were reported.

They found many of the children affected had obstructive sleep apnea and “had evidence of being ultrarapid metabolizers of codeine, which is an inherited (genetic) ability that causes the liver to convert codeine into life-threatening or fatal amounts of morphine in the body.”¹³

“Since these children already had underlying breathing problems, they may have been particularly sensitive to the breathing difficulties that can result when codeine is converted in the body to high levels of morphine,” the FDA announced.¹⁴

“However, they continued, “this contraindication applies to all children undergoing tonsillectomy and/or adenoidectomy because it is not easy to determine which children might be ultrarapid metabolizers of codeine.”

The end result was a black-box warning, the FDA’s strongest warning, added to the label of codeine-containing products advising against the use of such drugs in all children following tonsillectomy and/or adenoidectomy. 

In 2017, Chua and colleagues published a study that found the FDA’s investigation significantly reduced codeine prescribing to children after these procedures — but did not stop it entirely. In a review of 362,992 children who underwent tonsillectomy and/or adenoidectomy, 5.1% had one or more prescriptions for codeine filled in December 2015.

The researchers explained, “1 in 20 children undergoing these surgeries were still prescribed codeine in December 2015 despite its well-documented safety and efficacy issues.”¹⁵

Considering the risks of prescribing codeine to children, the inability to identify which children may be especially vulnerable to its effects and the widespread availability of nonopioid pain relief options, the researchers described prescribing codeine to children after tonsillectomy an “unnecessary gamble, “particularly for children with OSA [obstructive sleep apnea], who are at a higher risk for opioid-related respiratory depression.”¹⁶

Parents mistakenly believe opioids are best for pain

Despite widespread media headlines highlighting the risks of opioid abuse and overdose deaths, many parents still believe they’re the most effective option for pain relief. In a survey commissioned by the American Society of Anesthesiologists, nearly two-thirds of parents surveyed believed opioids were better for pain management after surgery or a broken bone than alternatives.¹⁷

In reality, research published in the Journal of the American Medical Association (JAMA) suggests that less risky opioid-free options may work just as well.¹⁸

The study evaluated the effects of four different combinations of pain relievers — three with different opioids and one opioid-free option composed of ibuprofen (i.e., Advil) and acetaminophen (i.e., Tylenol) — on people with moderate to severe pain in an extremity, due to bone fractures, shoulder dislocation and other injuries.

The patients had an average pain score of 8.7 (on a scale of zero to 10) when they arrived. Two hours later, after receiving one of the pain-relief combinations, their pain levels decreased similarly, regardless of which drug-combo they received. Specifically, pain scores fell by:¹⁹

• 4.3 in the ibuprofen and acetaminophen group
• 4.4 in the oxycodone and acetaminophen group
• 3.5 in the hydrocodone and acetaminophen group
• 3.9 in the codeine and acetaminophen group

“For patients presenting to the ED [emergency department] with acute extremity pain, there were no statistically significant or clinically important differences in pain reduction at two hours among single-dose treatment with ibuprofen and acetaminophen or with 3 different opioid and acetaminophen combination analgesics,” the researchers concluded.²⁰

Opioid-related deaths among children nearly triple

The opioid epidemic kills 130 Americans daily,²¹ and sadly this sometimes includes children. While adult deaths due to opioid overdose have trended upward in recent years, so too have those among children.

From 1999 to 2016, 8,986 children and adolescents died due to opioid poisonings — an increase in mortality rate of 268.2%.²² Prescription opioids were responsible for 73% of the deaths, with the mortality rate increasing 131.3% during the study period.²³

According to the study, “These findings suggest that the opioid epidemic is likely to remain a growing public health problem in the young unless legislators, public health officials, clinicians and parents take a wider view of the opioid crisis and implement protective measures that are pediatric specific and family centered.”²⁴

The findings underscore the high risks involved when bringing opioids into your home and highlight the importance of choosing the least dangerous pain relief option available following surgeries like tonsillectomy.

If your child is scheduled to have this procedure, ask his or her doctor about pain relief options and express your desire for a nonopioid option. However, before choosing to have your child’s tonsils removed, be aware that the surgery itself is risky and may not be the best option for your child.

Risks of tonsillectomy may outweigh benefits

Tonsillectomies are often recommended for treatment of recurring, chronic or severe tonsillitis or complications resulting from enlarged tonsils, such as difficulty breathing at night.²⁵ However, the benefits of the surgery may not outweigh the risks, according to a population-based cohort study of 1,189,061 children.²⁶

In estimating the long-term disease risks associated with tonsillectomy in childhood, the researchers evaluated data from children who had their adenoids or tonsils removed within the first nine years of life, finding their removal to be associated with a significantly increased risk of respiratory, allergic and infectious diseases later in life.

“Increases in long-term absolute disease risks were considerably larger than changes in risk for the disorders these surgeries aim to treat,” the researchers explained.²⁷ Far from being superfluous tissue, your tonsils and adenoids play an important role in the development and function of your immune system, helping to protect against pathogens and stimulate immune response.²⁸

Short-term risks of tonsillectomy, meanwhile, also carry risks, including severe bleeding before or after surgery, swelling that can cause breathing problems, infection and reactions to anesthetics.²⁹

In some cases, a tonsillotomy, or partial removal of the tonsils, may be an alternative surgical option for both children and adults; however, parents should carefully consider whether surgery is the best option to resolve the underlying medical condition.

Finally, if you, your child or someone you love has chronic pain of any kind, know that there are many safe and effective alternatives to prescription and even over-the-counter painkillers that provide excellent pain relief without any of the health hazards that pain medications like opioids often carry.

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The exposure of medical fraud is not new. In the past, drugs have been brought to market before clinical trials revealed a deadly list of side effects, including heart attacks and deaths, as in the case of Vioxx.¹ ProCon.org published a list in 2014 of 35 drugs pulled from the market after research revealed they caused more damage than benefit to users.²

You need only take a cursory glance at the epidemic that opioid manufacturers have caused in their search for profit, sometimes boasting they could become an “end-to-end” provider by supplying both the addictive drug and the cure for the addiction.³

In 2015 Dr. Anil Potti from Duke University was found guilty of research misconduct,⁴ and Duke faced lawsuits filed by patients in his clinical trials.⁵ Potti’s research was first heralded as a groundbreaking game changer, but is now an example of how fraud can occur anywhere.

Had Duke University paid attention to reports from a medical student in 2008, they could have avoided the ensuing public and political challenges. Instead, Potti’s protectors pressured the student to be silent, in a move to protect their own interests.⁶

Recently, it was revealed that scientists at Novartis hid manipulated data from animal studies while seeking approval from the FDA for a gene therapy drug meant to treat babies with an inherited disease, spinal muscular atrophy.⁷

Big Pharma corrupts data but keeps profits

AveXis, a subsidiary of Novartis, is aimed at developing and commercializing gene therapy.⁸ May 24, 2019, the company received approval to release Zolgensma, which was considered a major milestone. However, it is also the most expensive treatment ever offered on the market, at a whopping price of $2.1 million for a single dose.^9,10

AveXis knew of the data manipulation in March,¹¹ a full two months before the drug was officially approved by the FDA. Dr. Wilson Bryon, director of the FDA division reviewing the drug, commented to STAT¹² that had the agency been told of the data manipulation, approval of the drug would have been delayed.

In what appears to be an opposing statement, Dr. Peters Marks, director of the FDA’s Center for Biologics Evaluation and Research,¹³ was quoted in a press release saying,¹⁴ “The FDA is carefully assessing this situation and remains confident that Zolgensma should remain on the market.” In the same statement Marks also said,¹⁵ “The agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties.”

In a letter to Ned Sharpless, acting head of the FDA, five senators wrote,¹⁶ "This scandal smacks of the pharmaceutical industry's privilege and greed, and Americans are sick of it.” The senators urged the FDA to take action:¹⁷

" … to use your full authorities to hold AveXis accountable for its malfeasance. Anything short of a forceful response would signal a green light to future pharmaceutical misbehavior."

Business Insider¹⁸ reports Novartis declined to comment on the content of the letter from the senators. In a Twitter conversation¹⁹ between Dr. Peter Bach²⁰ of Memorial Sloan Kettering Cancer Center and past FDA Commissioner, Dr. Scott Gottlieb,^21,22 the problem was clearly acknowledged:

Bach: “I don’t know the rules in detail, but presumably Nvs could have told the FDA to pause its review to ensure the approval was not based on data suspected to be (or known to be) fabricated. This whole thing has the ‘wrongs were committed but there were no wrongdoers’ feel.”

Gottlieb: “Based on the tone and substance of the FDA statement today, Peter, I suspect there will be wrongdoers here. And consequences.”

Drugmakers not required to report suspected data corruption

In their letter to Sharpless, the five senators described how taxpayers had funded benefits to Novartis in order to speed the regulatory and approval processes for their new drug. They wrote:²³

“What makes this unscrupulous action even more appalling is the fact that AveXis was the beneficiary of numerous federal taxpayer-funded benefits and incentives, including obtaining Fast Track, Breakthrough Therapy, and Priority Review designations — ensuring that Zolgensma would be sped through the regulatory approval process. All the while, AveXis breaks records, and budgets, with its staggering $2.1 million price.”

In the same letter, the senators requested that the FDA answer questions about how it plans to deal with cases of data manipulation from drug companies. Additionally, they wanted an explanation about why the FDA had decided to drop a regulation requiring pharmaceutical companies to report any suspected data manipulation.²⁴

Dr. Vasant Narasimhan became the chief executive officer of Novartis on February 1, 2018.²⁵ Narasimhan defended the company's decision to delay release of the information about manipulated data and said the company “thoroughly, aggressively”²⁶ investigated the issue.

The New York Times²⁷ reports that when Narasimhan assumed this role, his mission was to restore the reputation of Novartis following several allegations of price-fixing, past data manipulation and the decision to hire Michael Cohen, President Trump’s ex-lawyer who pleaded guilty to making false statements to Congress.²⁸

Narasimhan said they waited before releasing information about data manipulation in order to perform their own internal investigation and not in an effort to hasten the approval process.²⁹ Novartis continues to assert the falsified data were limited to the early phases of research involving animals; this was discontinued in the summer of 2018.

Insurance companies picking up $2.1 million bill

While Zolgensma is the second gene therapy drug to be approved by the FDA, the government agency expects to be approving between 10 and 20 cell and gene therapy products each year by 2025.³⁰ Zolgensma is a $2.1 million one-time drug for the treatment of spinal muscular atrophy in children under 2.

Spinal muscular atrophy is a muscle wasting disease, affecting about 400 children each year. In the most severe form, children die before age 2. At one point, UnitedHealthcare refused payment for several cases. Later, they reversed their decision after pressure from families and intense media coverage.³¹

The FDA released an inspection report from the mice used in the early phases of the research and found how long the mice lived was different from the actual value in some cases. While the FDA reported the data were manipulated, they would not say if they believed the information was deliberately falsified.³²

Novartis concerned regulations may impact business

The high cost of prescriptions has become a political issue, with most calling for change. Bausch Health, possibly best known for their eye care products, is led by CEO Joseph Papa. In an interview with CNBC, Papa said pharmaceuticals are the most cost-effective way to treat and improve health care.³³

Also under the Bausch Health umbrella is a dermatology business, Ortho Dermatologics, which received approval in early 2019 for a lotion to treat psoriasis. In two clinical trials, the drugmaker posted a success rate of 36% in the first study and 45% in the second.

Despite pledges from Congress to help regulate prescription prices, Papa remains unconcerned.³⁴ However, Novartis is not quite as unruffled by movements in Congress toward greater regulation.

The company is standing behind their newest gene therapy drug, and defends the massive price tag that nearly all families would find impossible to pay without full coverage insurance. At the same time, Novartis’ annual report cites concern for transparency in the way their company may be forced to do business:³⁵

“For example, we are faced with increasing pressures, including new laws and regulations from around the world, to be more transparent with respect to how we do business, including with respect to our interactions with healthcare professionals and organizations.

These laws and regulations include requirements that we disclose payments or other transfers of value made to healthcare professionals and organizations, as well as information relating to the prices for our products. Such measures, including any additional such measures that may be put in place, could have a material adverse impact on our business, financial condition, or results of operations.”

Novartis dumped vaccine program and more

Novartis’s headquarters are in Switzerland and the company has offices in multiple countries.³⁶ If their name sounds familiar it might be from years of manufacturing and supplying vaccines, including flu vaccines and those for meningitis B. Their vaccine division was formed in 2006 but began posting losses in 2013.³⁷

In 2015, Novartis sold the flu vaccine business for $275 million to Australia's CSL. This placed CSL as the world's second largest flu vaccine supplier.³⁸ The acquisition also included the cell-based manufacturing facility in North Carolina.

This was a win for CSL as it was the first of its kind in the U.S. The cost of $487 million was in part paid by the U.S. Department of Health and Human Services. This was a part of the organization’s pandemic preparedness efforts.³⁹ In other words, U.S. taxpayers funded the facility, which was later sold to Australia.

GlaxoSmithKline acquired the remaining vaccine business from Novartis in 2015 for $7.1 billion, which included nearly 20 vaccines the company had in development.⁴⁰ In addition, GSK divested its oncology portfolio to Novartis for cash consideration of $16 billion.⁴¹

Novartis began their companywide restructure with the divestment of their vaccine portfolio, over-the-counter drugs and animal health sections.⁴² In another deal closed December 2015, Novartis sold Kayersberg Pharmaceuticals from their Alcon unit in a bid to improve financial margins and focus their attention in a different direction.⁴³

By June 2018, Novartis had announced the sale of the entire Alcon eye-care unit⁴⁴ as Narasimhan continued to focus the attention of the company on prescription drugs. In 2018, Novartis bought AveXis for $8.7 billion to acquire the then experimental Zolgensma.⁴⁵

As the pharmaceutical industry jockeys for position in an ever-changing political environment, it is the consumer who ultimately loses the battle. Although Papa believes pharmaceutical treatments are the answer to health and wellness, it has been my assertion for decades your life choices have a significant effect on your health, including nutrition, sleep, hydration and exercise.

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Health care is becoming increasingly digitalized, starting with online medical records and now moving toward replacing human health care providers with robots. Writing in JAMA Network Open, a team of doctors and researchers from MIT and Brigham and Women’s Hospital, Boston, cited the COVID-19 pandemic as being instrumental in the expansion of telehealth offerings at many health care systems.¹

The goal of telehealth is to limit human contact to lower the risk of infectious disease transmission, but removing the human element of care dramatically changes the doctor-patient relationship. While most existing telehealth systems involve the patient controlling a tablet or smartphone, the researchers suggested that a mobile robotic telehealth system controlled by clinicians would offer a more dynamic experience.

However, before implementing robots to engage with patients in emergency rooms across the U.S., they wanted to find out if robots would be accepted — and they were surprisingly well received.

Americans Open to Robotic Care

In the early days of the COVID-19 pandemic, the researchers began to look for ways to minimize interactions between patients coming into emergency rooms and health care providers. In cooperation with Boston Dynamics, they created mobile robots that can measure vital signs like temperature, breathing rate, pulse rate and blood oxygen saturation.

The dog-like robots have four legs and carry an iPad that allows for video communication with a health care provider.²

"Often as engineers, we think about different solutions, but sometimes they may not be adopted because people are not fully accepting of them," study author Giovanni Traverso said in a news release. "So, in this study we were trying to tease that out and understand if the population is receptive to a solution like this one."³

First, they conducted a U.S. survey of 1,000 people to gauge attitudes about using robotic systems in hospital settings. In addition to questions about their usefulness in carrying out specific health care tasks, the participants were asked to consider their usefulness “with an emphasis on using robotic systems to limit direct human contact and conserve personal protective equipment” during the pandemic.⁴

The results revealed that most people were open to robotic health care services, including not only initial interviews and reading of vital signs but also somewhat more complex procedures, like testing for COVID-19 using a nasal or oral swab, placing an intravenous catheter, drawing blood and moving critically ill patients into a prone position.⁵

"Surprisingly, people were pretty accepting of the idea of having a robot do a nasal swab, which suggests that potential engineering efforts could go into thinking about building some of these systems," the study’s lead author, Peter Chai, said.⁶

Most Said Robot Care Was Similar to In-Person Care

The next phase of the study took place in Brigham and Women’s Hospital’s emergency department. Fifty-one patients were approached about taking part in the robot study, and 41 agreed to participate (one did not get to complete the experiment because of a signaling malfunction with the robot).

The robot, controlled by a clinician, was then navigated to the patient and a video triage interview was conducted via the robot’s tablet computer.

Patients were then asked to evaluate the experience. Out of the 40 patients, 37 (92.5%) said the experience was satisfactory, and 33 (82.5%) said that being interviewed by the robotic system was as satisfactory as being interviewed in-person by a clinician. "For the purposes of gathering quick triage information, the patients found the experience to be similar to what they would have experienced talking to a person," Chai said.⁷

The team is now working on smaller robots that would be able to interact with patients outside of a typical hospital setting, such as in an ambulance or field hospital, as well as developing sensors that could take vital signs remotely.⁸

Another piece of the puzzle, however, before the widespread rollout of robotic health care can take place, is ensuring that people will accept this impersonal technology. As such, they stress, “Future work may consider approaches to maximize acceptance of robotic systems among patients, especially those who declined to participate in the present study.”⁹

Health Passports: Another Form of Digital Health Care

It’s likely only a matter of time before you’ll be asked to prove your vaccination status in order to carry on with your daily life. “The government seems to be developing vaccine passports by stealth, making sure the technology is in place for anyone who needs it,” wrote Lara Prendergast, The Spectator’s assistant editor.¹⁰

She’s referring to the U.K. government, which has given sizable grants to a number of private companies developing such technology, however vaccine passports are also being implemented around the world. Denmark, Sweden, Spain, Italy, Cyprus and Malta are among the countries that have expressed positivity toward vaccine passports to revive tourism, while in the U.S., plans for vaccine IDs are under evaluation.¹¹

The Commons Project and the World Economic Forum created the Common Trust Network, which developed the CommonPass app that’s intended to act as a health passport in the near future.

The app allows users to upload medical data such as a COVID-19 test result or proof of vaccination, which then generates a QR code that you will show to authorities as your health passport.¹² The proposed common framework “for safe border reopening” around the world involves the following:¹³

1. Every nation must publish their health screening criteria for entry into the country using a standard format on a common framework
2. Each country must register trusted facilities that conduct COVID-19 lab testing for foreign travel and administer vaccines listed in the CommonPass registry
3. Each country will accept health screening status from foreign visitors through apps and services built on the CommonPass framework
4. Patient identification is to be collected at the time of sample collection and/or vaccination using an international standard
5. The CommonPass framework will be integrated into flight and hotel reservation check-in processes

Eventually, the CommonPass framework will be integrated with already existing personal health apps such as Apple Health and CommonHealth. If you want to travel, your personal health record will be evaluated and compared to a country’s entry requirements, and if you don’t meet them, you’ll be directed to an approved testing and vaccination location.

Significant Human Rights Concerns

Airline JetBlue announced that passengers flying to Aruba from Boston’s Logan International Airport could use the CommonPass digital health pass to enter the country.¹⁴ The plan is to quickly expand the program to other cities in JetBlue’s network — and this is only the beginning.

But, while being positioned as a way to regain a sense of normalcy and travel with ease, it’s actually a restriction of freedom — one in which you must “present your papers” before you can cross a border. The “easy” steps to enter Aruba, which prior to the pandemic would have consisted of showing your passport, now include:

• Download the CommonPass app
• Get tested for COVID-19 by COVID testing companies Vault and XpresCheck, either at home or at the airport
• Prior to your flight, enter your “invitation code” into the CommonPass app and upload your COVID-19 test results into CommonPass
• Fill out an online embarkation-disembarkation card, which includes your negative PCR molecular COVID-19 test; you can add your CommonPass ID in order to pre-verify with Aruba that you are “cleared to travel”
• Upon arrival in Aruba, proceed through the “dedicated CommonPass immigration lanes to start … vacation sooner”

Already, this is creating two “classes” of people — those who have the CommonPass and those who don’t. This is just one of the significant human rights and civil liberty concerns being created by the implementation of digital health passports.

As noted by Rosalind Comyn, policy and campaigns manager at the National Council for Civil Liberties in the U.K., “In essence, what vaccine passports are trying to do is create a system whereby some people can access freedoms, services or other kind of spaces and places and other people are excluded from them.”¹⁵

Big Tech Striving To Be a Digital Health Power Player

From robotics to artificial intelligence (AI), the future of health care is digital, and technology companies like Google are investing heavily in this area. In November 2018, for instance, Google hired the former CEO of Geisinger Health, David Feinberg, to run its Google Health initiative and soon after acquired DeepMind Health, which is part of an AI company creating AI assistances for health care providers.¹⁶

Google is working on developing voice recognition technologies to support doctors in their paperwork along with an image library that trains AI models to detect diseases. It’s also involved in electronic health records, developing a model that uses machine learning to make predictions about patient outcomes, like the likelihood of readmission or death.¹⁷

It’s a concerning trend, considering the “frightening”¹⁸ amount of data Google and other technology companies collect. WebMD dominates health searches done through Google and shares user information with Google’s advertising arm and other third-party firms — a practice that is illegal in Europe.

Google, Amazon and Microsoft collect data entered into health and diagnostic sites, which is then shared with hundreds of third parties — and this data is not anonymized, meaning it’s tied to specifically to you, without your knowledge or consent.¹⁹

What this means is DoubleClick, Google’s ad service, knows which prescriptions you’ve searched for on the site, thus providing you with personalized drug ads, and Facebook knows what you’ve searched for in WebMD’s symptom checker, as well as any medical diagnoses you received.

This, along with many other behind-the-scenes partnerships, adds up to large-scale generation of health-related data points that could be used for targeted advertising, insurance premium decisions and much more.

Protecting Your Privacy From Technology

I’ve been talking about the privacy risks associated with online health records since 2008. The risks, and privacy-encroaching technologies, have only increased since then. The use of robots to replace in-person meetings with your doctor are only the beginning, as are the health passports starting out with the COVID-19 vaccine or a negative COVID test for international travel.

It’s setting a precedent for expansion that can be extended to other vaccines and medical information, and then to domestic travel and even leaving your house, as the passports will be carried on your phone that has location-tracking abilities. The creation of a decentralized web is part of the answer to protecting your freedom but you can also consider safeguarding your own online privacy if you haven’t done so already.

To encrypt your text messages and keep them from becoming data mining fodder, download the Signal or Telegram app and/or use a virtual private network (VPN) on your desktop, laptop and mobile devices. As far as robotic doctors go, you’re likely going to see more of them, to the point that one day they may play a larger role in health care than people.²⁰

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