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Last Build Date: Wed, 18 Apr 2018 18:22:44 +0000

 



New bill would push Veterans Affairs office to study cannabis

Wed, 18 Apr 2018 18:22:44 +0000

Lawmakers are frustrated with the agencys reluctance to explore marijuana as the nation faces a deadly opioid epidemic

By Amy Martyn of ConsumerAffairs
April 18, 2018

(image) A bipartisan group of lawmakers are once again pushing the the Department of Veterans Affairs (VA) to soften its attitude on marijuana.

Representatives Phil Roe ( R-Tenn) and Tim Walz (D-Minn), who both lead the House Veterans Affairs Committee, on Monday introduced the VA Medicinal Cannabis Research Act of 2018.

The bill would give the VA authority to conduct its own research into cannabis, in particular to study whether it is beneficial to veterans suffering PTSD, chronic pain, and other conditions. The agency would also have to supply congress with regular reports about their research efforts, according to an early draft of the bill.

Opening up ability to research

The proposal is just the latest that lawmakers have made over the years to encourage the VA to study cannabis. A wealth of research suggests that medical marijuana can be a viable alternative to more addictive and dangerous drugs.

The push to get the VA office to take marijuana seriously has reached a new urgency as veterans and others across the United States are in the grips of a deadly opioid epidemic. Lawmakers have repeatedly asked the VA to explore marijuanaas a possible alternative to opioids, but the agency has responded by claiming that federal law restricts their ability to conduct such testing, as the Military Times reported.

Its time the VA did a formal study, Rep. Lou Correa (D-Calif) told the publication. Rather than risk becoming dependent on opioids, these veterans find relief in medical cannabis. I want to bring these brave men and women the relief they deserve. This legislation will finally allow the VA to perform research on medical cannabis.

Pushing past current prohibitions

Last year, the VA rolled out new rules allowing doctors to discuss marijuana with veterans who request information. But discussing marijuana is about all the doctors can do, according to the agencys rules.

Providers are prohibited from completing forms or registering Veterans for participation in a State-approved marijuana program, the agency said at the time, citing the Federal Controlled Substances Act that criminalizes marijuana at the federal level.




Texas may confiscate CBD products from retailers

Wed, 18 Apr 2018 15:14:36 +0000

A non-euphoric product thought to have medical benefits began appearing on store shelves in the state this year

By Amy Martyn of ConsumerAffairs
April 18, 2018

(image) The first legal cannabis product in Texas was delivered to a six-year-old girl in February who suffers from epilepsy. Advocates hailed the delivery as a major step forward for Texas consumers who find relief from cannabidiol (CBDs) -- a chemical in cannabis that does not get users high but is thought to have medical benefits.

Though the feds have not made CBDs available to marijuana researchers, a cache of anecdotal evidence and research conducted in other countries suggests that it can control epileptic seizures in some patients

The young patient was able to receive CBDs under Texas Compassionate Use Act, a restrictive law that legalized CBDs in the state in 2015 but was not implemented until February of this year.

Since then, numerous CBD products have appeared on store shelves in Texas this year -- and Texas officials are now threatening to take them away.

Officials with the Texas Department of State Health Services are warning retailers that they are not allowed to sell CBDs under the state law. The state health department is currently considering a proposal that would give inspectors authority to confiscate unauthorized CBD products from store shelves.

An agency spokesman told the Dallas Morning News that the state is simply trying to comply with federal anti-drug laws. The enforcement would not apply to dispensaries that are allowed to sell CBDs under the states Compassionate Use Act.

Taking a step back

Obtaining CBDs under Texas recently implemented law remains incredibly difficult. Under the Compassionate Use program, only people suffering from epilepsy who have tried two FDA-approved treatments, and found them to be ineffective, can receive the substance. Even then, the patients must receive a recommendation for CBD oil from a doctor who is listed on the states Compassionate Use Registry -- and only 20 doctors are currently on the list for the entire state.

Whats more, only three dispensaries have received authorization from the Texas Department of Public Safety to grow and distribute CBD products under the Compassionate Use Program. The chief executive of Compassionate Cultivation, one of the approved dispensaries, is nonetheless speaking out against the states potential CBD crackdown on unapproved dispensaries.

Its troubling to me that a great percentage of Texans will no longer be able to achieve that benefit, Denton told the Texas Tribune. If you are just taking a product away from people that has helped them, but not giving them a legal solution, then I think that is a step back.

In January, a University of California, San Diego weed researcher told ConsumerAffairs that the anecdotal evidence into the potential medical benefits of CBD was astonishing.

But because the Drug Enforcement Agency has only made weed and not CBD oil available to researchers, "there is virtually no research on the health benefits of CBD, he said.




FDA to ban pure, highly concentrated bulk caffeine supplements

Mon, 16 Apr 2018 14:06:38 +0000

Federal regulators are taking another step to stop consumers from ingesting dangerously high levels of pure caffeine By Sarah D. Young of ConsumerAffairs April 16, 2018 The U.S. Food and Drug Administration (FDA) announced Friday new guidance on the sale of supplements containing high amounts of caffeine. Supplements that contain pure or highly concentrated caffeine in powder or liquid forms "present a significant public health threat, the FDA said in a statement. These supplements are no longer permitted to be sold in bulk quantities directly to consumers, the agency said. The FDA said it is ready to take action to remove these dietary supplements from the market after reports of at least two deaths in otherwise healthy individuals. Dangerous caffeine cocktails Accidental ingestions can occur if a consumer mistakes the liquid form of these products for a safe household liquid, such as water or distilled vinegar. Pure powdered caffeine could easily be confused with flour or powdered sugar. The consequences of a consumer mistakenly confusing one of these products could be toxic or even lethal, the FDA wrote. The agency is especially concerned about the health effects that can occur when these products are intentionally misused. We know these products are sometimes being used in potentially dangerous ways. For example, teenagers, for a perceived energy kick, sometimes mix dangerously high amounts of super-concentrated caffeine into workout cocktails, said commissioner Scott Gottlieb. The amounts used can too easily become deceptively high because of the super-concentrated forms and bulk packaging in which the caffeine is being sold." Gottlieb added. Equivalent to 20 to 28 cups of coffee A half cup of a highly concentrated liquid caffeine can contain approximately 2,000 milligrams (mg) of caffeine. A single teaspoon of a powdered pure caffeine product can contain approximately 3,200 mg of caffeine. That's the equivalent of 20 to 28 cups of coffee -- a potentially toxic dose of caffeine, the agency noted. Ingesting just a few tablespoons of some formulations of powdered, pure caffeine can be deadly to most adults, and even smaller amounts can be life-threatening to children. Bulk amounts of these supplements pose a high risk of overuse and misuse because consumers have to measure a very small, precise, recommended serving, and often they do not have the proper tools to do so, the FDA explained. The recommended safe serving is 200 mg, which is about 1/16 of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid. Previous measures to curb overuse In 2015 and 2016, the FDA issued warning letters to five sellers of powdered caffeine in an effort to stop these highly concentrated or pure caffeine supplements from being sold directly to consumers online. However, the supplements remained on the market. "Despite multiple actions against these products in the past, we've seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container," Gottlieb said. The FDA is now banning the sale of pure or highly concentrated caffeine in powder or liquid forms in bulk quantities directly to consumers. The new rule is effective immediately. [...]



Goldman Sachs warns biotech clients that curing patients may not be ‘sustainable’

Wed, 18 Apr 2018 14:48:37 +0000

As consumers question whether privatized healthcare is in their best interest, Goldman Sachs says that curing hepatitis C caused a drop in one firms drug sales By Amy Martyn of ConsumerAffairs April 13, 2018 In a report recently published for its biotech clients, Goldman Sachs questioned whether curing people is good for business. "Is curing patients a sustainable business model?" the company's analysts asked in an April 10 report about promising research into the human genome. The Goldman Sachs report, which was obtained by CNBC, does not answer that uncomfortable question directly. But it does point to pharmaceutical company Gilead Sciences as a cautionary tale. The company introduced a treatment for hepatitis C in 2015 that cured more than 90 percent of patients. In the years since, sales of the treatment dropped drastically, according to Goldman Sachs. While one shot cures are one of the most popular aspects of genome research, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies," Goldman Sachs analyst Salveen Richter reportedly wrote to clients. "While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow, he added. Concern over high healthcare costs The outright acknowledgment from the financial services industry that curing diseases with a single treatment is not profitable comes as more American consumers are questioning the value of privatized healthcare. Addressing concerns about high healthcare costs, a group of United States lawmakers led by Sen. Bernie Sanders (D-VT) last year introduced legislation that would expand Medicare to the entire population. Sanders and the other lawmakers have pointed to Canada, France, and other countries with socialized medical servicesas inspiration for the legislation. Research from the Commonwealth Fund has repeatedly found that Americans suffer worse healthcare outcomes despite paying more for their care than citizens in any other industrialized nation. The biotech industry justifies high drug prices by claiming that their research and development costs billions and that they are in the business of saving lives. But independent researchers have repeatedly debunked the industrys figures and pointed out that in countries with stricter price regulations, pharmaceuticals are significantly cheaper. Developing drugs, while expensive, has shownnot to be nearly as costly as the industry claims. Addressing "large markets" more profitable In its advice to clients, Goldman Sachs acknowledges that while saving lives is an admirable goal, it has traditionally been more profitable to save the lives of people suffering from common and chronic diseases. For genomic medicine to be as profitable as therapies of yesteryear, Goldman Sachs proposes that the biotech industry address large markets, such as Hemophilia, a disease that the firm says is worth up to $10 billion and growing at ~6-7% annually. The firm also suggests that companies address disorderswith high incidence or that the biotech industry simply cure previously incurable diseases through constant innovation and portfolio expansion. [...]



Spinach is showing a ‘sharp increase’ in pesticides, report says

Wed, 18 Apr 2018 14:52:14 +0000

Spinach carries more pesticides than any other crop tested by the USDA

By Amy Martyn of ConsumerAffairs
April 13, 2018

(image) A diet full of fruits and vegetables is better than a diet without them, but if possible, consumers should go organic when purchasing certain leafy greens and other produce, according to the Environmental Working Group (EWG).

Its tried and true advice given by the EWG when they release their annual their lists of fruits and vegetables that accumulate the most and least amount of pesticides.

But some produce, notably spinach, seems to be getting worse. According to federal data analyzed by the EWG, spinach samples are showing a sharp increase in pesticide residue. Non-organic spinach samplescontained far more pesticides by weight than all other crops tested, the EWG reported.

High levels of pesticide residue

Using data provided by the U.S. Department of Agriculture (USDA), the EWG reported in their 2018 shoppers guide, released this week, that non-organic strawberries, spinach, nectarines, apples, grapes, peaches, cherries, pears, tomatoes, celery, potatoes and sweet bell peppers all had potentially harmful levels of pesticide residues, as they have in previous years.

While most pesticide samples found on the samples are legal in the United States, many samples, particularly spinach, contained relatively high levels of permethrin. The chemical has been banned in Europe since 2000 for use on food crops, due to some research suggesting it has neurotoxic effects on children even at low levels.

And the pesticide DDT, which has been banned in the United States for nearly fifty years, was present on 40 percent of spinach samples. EWG researchers speculate that the DDT is appearing on spinach due to residual product that remains in the soil.

EWG advises consumers to buy organic spinach and other leafy greens if you can and to wash all produce thoroughly before eating it, though they add that the USDA washed all of the spinach samples vigorously before testing.

Meanwhile, produce covered with thick, non-edible skins, such as avocado, eggplant, pineapple, cantaloupe, and honeydew continue to score well in terms of pesticide residue. Cabbage, cauliflower, and broccoli also had relatively low pesticide levels.




Surgeon general says more consumers should carry opioid antidote Naloxone

Fri, 06 Apr 2018 13:10:14 +0000

CVS says it will automatically apply a coupon for the drug

By Sarah D. Young of ConsumerAffairs
April 6, 2018

(image) The US Surgeon General released a rare public health advisory on Thursday urging more Americans to carry naloxone, a drug which can reverse the effects of an opioid overdose.

Dr. Jerome M. Adams says keeping naloxone on hand -- and knowing how to use it -- can save a life. The drug, which is commonly known as Narcan, can restore normal breathing in someone suspected of overdosing on opioids, including heroin and prescription pain medications.

The advisory applies to patients taking opioids for pain, individuals misusing prescription drugs, people using illicit opioids like fentanyl or heroin, health care practitioners, family, and friends of possible abusers, and others who come into contact with people at risk for opioid overdose.

Combating the opioid epidemic

Adams noted that the number of overdose deaths from prescription and illicit opioids has doubled in recent years, from 21,089 in 2010 to 42,249 in 2016.

"Each day, we lose 115 Americans to an opioid overdose -- that's one person every 12.5 minutes," said Adams. "It is time to make sure more people have access to this lifesaving medication, because 77 percent of opioid overdose deaths occur outside of a medical setting and more than half occur at home."

To stop the opioid epidemic, we must stop the bleeding, Adams said.

The newly-released statement was the first public health advisory issued by Americas top doctor in more than a decade. The last surgeon generals advisory focused on drinking during pregnancy.

CVS has announced it will accept and automatically apply a coupon for Narcan, a nasal spray version of the drug, for patients who don't have insurance. The reduced out-of-pocket cost will be $94.99.

The head of the Food and Drug Administration (FDA), Scott Gottlieb, also said this week that he would work to help better educate and guide doctors on the best ways to treat pain, including prescribing lower doses of opioids.

"When you have tens of millions, even hundreds of millions of prescriptions being written, that's a lot of potential for abuse," Gottlieb told CNN. "So, I think a key is to try to bring down overall exposure to these drugs."




Why rates of whooping cough are rising once again

Wed, 04 Apr 2018 11:45:02 +0000

Researchers say the honeymoon phase of immunity is coming to an end By Christopher Maynard of ConsumerAffairs April 4, 2018 Despite high vaccine coverage in many developed countries, pertussis otherwise known as whooping cough has made a comeback in recent years. The condition accounts for nearly 200,000 infant deaths each year, with rates increasing steadily since the 1970s. While past research has placed blame for the diseases resurgence on flaws in the current generation of vaccines, a new study suggests that the real reason is that weve reached the end of the honeymoon stage when it comes to immune protection. Senior author Pejman Rohani explains that the vaccine that was first administered decades ago has left current generations exposed. "This study is important in that it revealed that there has been no change to the epidemiology of pertussis that is causing the rise in the number of cases," Rohani said. "Instead, it is a function of the way vaccines were administered over the decades. It is an effect that takes a long time to manifest." Less than optimal vaccines Routine vaccinations for pertussis began in the 1940s, and the immediate impact was a drastic decrease in cases of the condition. Even consumers who werent vaccinated became far less prone to contracting it because of the overall decreased rate of transmission. However, the researchers explain that shortcomings in that first vaccine have led to slowly degrading immunity rates among consumers -- a fact that has left current consumers with inadequate resistance to the disease. This finding stands apart from other arguments in the scientific community that places the blame on current vaccinations. Our results suggest that the resurgence of pertussis is a predictable consequence of incomplete historical coverage with an imperfect vaccine that confers slowly waning immunity, the researchers said. We found evidence that the vaccine itself is effective at reducing overall transmission, yet that routine vaccination alone would be insufficient for elimination of the disease. Children most at risk Although adults are at risk of contracting pertussis, the study reaffirms that young children are the primary group affected by the condition. The researchers recommend that this group and especially vulnerable children be targeted with additional treatments to reduce the overall number of sicknesses. Efforts aimed at curtailing transmission in the population at largeare more likely to succeed if targeted at schoolchildren, rather than adults, the researchers said. The full study has been published in Science Translational Medicine. [...]



States are falling short in dealing with opioid crisis, report finds

Wed, 04 Apr 2018 14:22:58 +0000

The National Safety Council says just 13 states are on the right track

By Mark Huffman of ConsumerAffairs
April 3, 2018

(image) A new report from the National Safety Council finds most states have failed to implement effective policies to tackle the opioid addiction crisis in America.

In fact, the Council said only 13 states -- Arizona, Connecticut, Delaware, Washington, D.C., Georgia, Michigan, Nevada, New Hampshire, New Mexico, North Carolina, Ohio, Rhode Island, Virginia, and West Virginia -- have improved their approach to the drug epidemic in the last year.

Eight states -- Arkansas, Iowa, Kansas, Missouri, Montana, North Dakota, Oregon and Wyoming -- received failing grades, having adopted just one or two out of six key actions recommended in the report.

'Need to wake up'

"While we see some states improving, we still have too many that need to wake up to this crisis," said Deborah A.P. Hersman, the Council's CEO. "For the last five years, the Council has released Prescription Nation reports to provide a road map for saving lives across the country. We hope states adopt the recommended actions laid out here so we can eliminate preventable opioid deaths and stop an everyday killer."

The National Institute on Drug Abuse reported last month that opioid overdose -- which includes heroin as well as prescription painkillers -- kills an average of 115 Americans each day. Beside the toll in lives and health, the Centers for Disease Control and Prevention (CDC) estimates prescription opioid abuse is an $78.5 billion drain on the U.S. economy each year.

Some states where opioid abuse is particularly bad have a much bigger challenge. In February, Maine Attorney General Janet Mills reported 418 drug overdose deaths in the state in 2017, an 11 percent rise over 2016 -- when deaths surged 40 percent over 2015.

Deadly rise of illegal fentanyl

The report said 85 percent of opioid-related deaths were caused by the victim taking one or more opioid drugs, with a 27 percent increase in deaths due to illegal fentanyl and fentanyl analogs. Heroin overdose deaths, meanwhile, declined.

Drug manufacturers have come under fire for allegedly assuring medical practitioners that these powerful prescription painkillers are not addictive. In February, Sen. Claire McCaskill (D-Mo.) released a report tracing payments from major opioid drug makers to third party advocacy groups that have promoted the use of painkillers.

McCaskill says her report describes how drug makers have invested heavily in third party organizations that serve as pro-opioid advocacy groups. The report says these groups have issued guidance that minimizes the risks of opioid addiction and endorses opioid use for the long-term treatment of chronic pain.




Judge rules coffee sold in California must carry cancer warning

Wed, 11 Apr 2018 14:04:40 +0000

A consumer group sued Starbucks under Prop 65

By Mark Huffman of ConsumerAffairs
March 30, 2018

(image) A superior court judge in Los Angeles has ruled in favor of a consumer group that demanded Starbucks and other coffee sellers in the state post cancer warnings to customers.

The warning stems, not from the beans, but the chemicals used in the roasting process.

The Council for Education and Research on Toxics, a nonprofit group, filed suit against nearly 100 coffee companies, including Starbucks, claiming they were violating a California law requiring warnings on a wide range of chemicals that can cause cancer.

Acrylamide, a chemical used in the roasting process. is officially classified as a carcinogen.

'Not enough to be harmful'

Coffee companies argued that the chemical is not present in coffee to an extent to be harmful. They claimed the suit, brought under The Safe Drinking Water and Toxic Enforcement Act, better known as Proposition 65, was not meant to regulate chemicals in such small amounts. They also argued that coffee, overall, is a healthy beverage.

The judge, however, disagreed, saying the coffee industry hadn't proved it -- at least not in his courtroom.

In a statement, the National Coffee Association said the industry is considering all options, including appeals and other legal action. It also says cancer warning labels on coffee would be misleading, pointing out the U.S. governments own Dietary Guidelines say coffee can be part of a healthy lifestyle.

Coffee has been shown, over and over again, to be a healthy beverage," said National Coffee Association CEO Bill Murray. "This lawsuit has made a mockery of Prop 65, has confused consumers, and does nothing to improve public health.

Decades of conflicting studies

Coffee has been the subject of conflicting health findings over more than four decades. In the early 1970s, it was linked to heart disease. Later, if was found to be both a cause of cancer and a prevention against it.

Over the years, ConsumerAffairs has documented the conflicting findings here.

In 2016, the World Health Organization reviewed 25 years of research in concluding that coffee should not be considered a carcinogen and that it may have positive health effects. The report's only caveat was that any "very hot" beverage runs the risk of cancer.




Walmart reportedly in talks to buy Humana

Fri, 30 Mar 2018 14:04:51 +0000

The deal could continue a trend of consolidation in the healthcare industry

By Mark Huffman of ConsumerAffairs
March 30, 2018

(image) The nation's largest retailer is reportedly in talks to acquire one of the nation's largest healthcare providers.

The Wall Street Journal reports Walmart is in the very early stages of discussions with Humana that could continue the trend of retailers joining forces with the healthcare industry.

Such a deal, should it occur, would be Walmart's largest acquisition. Humana currently has a market cap of around $37 billion, compared to Walmart's value of $260 billion.

Walmart already operates pharmacies in 4,700 U.S. stores. It also has walk-in clinics in many of its locations that dispense vaccines and other routine healthcare services.

CVS and Aetna

The acquisition of Humana would follow CVS's announcement in December that it is acquiring Aetna, combining a large pharmacy chain with a major health benefits provider.

Health benefit companies like Aetna have enormous bargaining power with pharmaceutical companies. Combining that leverage with its own, CVS Health could be in a position to strengthen its competitive position in the marketplace, even against the likes of Amazon, which has reportedly been shopping for a healthcare partner.

A deal with Humana would take that company off the table, keeping it from linking up with Amazon, and help Walmart consolidate its foothold in the healthcare market. In particular, Humana's specialization in Medicare clients could help Walmart with seniors.

Cigna and Express Scripts

In early March, health insurance provider Cigna announced a $67 billion deal to acquire Express Scripts, a pharmacy benefits manager (PBM). The two companies said the merger would lead to a full suite of medical, behavioral, specialty pharmacy, and other health engagement services to give customers more options when it comes to their healthcare.

For consumers, it could all mean the lines between specific industries are blurring. When it comes to healthcare, it could shift from the doctor's office to a nearby retail store.

Reacting to the CVS-Aetna merger last December, Gerald Anderson, a professor at Johns Hopkins Bloomberg School of Public Health, says consumers would likely end up with fewer choices..

"If you have insurance through Aetna, most likely you are going to be going to a CVS and one of their Minute Clinics for healthcare," Anderson told ConsumerAffairs.




FDA may reconsider what ‘healthy’ means for food products

Thu, 29 Mar 2018 19:25:23 +0000

The agency announced a new initiative to improve consumer health

By Sarah D. Young of ConsumerAffairs
March 29, 2018

(image) The Food and Drug Administration (FDA) wants to improve Americans diets by rethinking what it means for food products to be considered healthy.

In a speech delivered Thursday at the National Food Policy Conference, Commissioner Scott Gottlieb outlined a nutrition innovation strategy, an initiative aimed at reducing obesity rates and preventing avoidable illnesses.

The agencys agenda may include a focus on reducing salt consumption and the creation of an icon or symbol to label food packages that meet the possible new definition of healthy. The FDA also wants to allow companies to use more easily understandable ingredient names (to make it clear, for example, that potassium chloride is a salt).

Cutting obesity rates

Gottlieb compared the initiative to the agency's new tobacco policy, which includes a proposal to reduce the amount of nicotine in cigarettes to minimal or non-addictive levels.

"Like our efforts to reduce tobacco use, our work in nutrition can do much to reduce the burden of chronic disease and the early death we see as a result of avoidable illness," Gottlieb said in the speech.

"It can also help to break cycles of poor health, poor educational attainment, and complications from chronic disease that exacerbate burdens of illness and risk fracturing society along socioeconomic lines, he added.

Updated targets for salt consumption would be aligned with recommendations currently being developed by the National Academy of Sciences, Gottlieb said.

"Improving the nutrition and diet of Americans would be another transformative effort toward reducing the burden of many chronic diseases, ranging from diabetes to cancer to heart disease," Gottlieb said. "The public health gains of such efforts would almost certainly dwarf any single medical innovation or intervention we could discover."

The agency will open a docket and hold a public meeting this summer on the proposals.




Ingredient in Monsanto’s Roundup spray linked to shorter pregnancies

Mon, 26 Mar 2018 16:01:51 +0000

Researchers in Indiana say that glyphosate may cause adverse health effects in fetuses By Amy Martyn of ConsumerAffairs March 23, 2018 Women in Indianas corn belt had shorter pregnancies if they were regularly exposed to glyphosate, a new peer-reviewed study has found Glyphosate is the most heavily used herbicide worldwide but the extent of exposure in human pregnancy remains unknown, Indiana University researchers write in the journal Environmental Health. The chemical is the active ingredient in Monsantos Roundup spray, which accompanies the companys genetically modified corn and soybean seeds so that farmers can freely kill weeds without destroying their seeds. Glyphosate-intensive farming has taken over industrial agriculture in the United States, resulting in 300 million pounds of the spray applied annually. Some researchers, as well as public health advocates and environmental groups, have charged that little is known about the potential health effects of exposure to a spray prevalent in the environment and the food supply. To study the effect of glyphosate on pregnancy, researchers with the Indiana University Fairbanks School of Public Health took urine samples from 71 pregnant women who live in central Indiana, which produces much of the worlds corn. More than 90 percent of the women had detectable levels of glyphosate present in their urine, and the study found that women with higher levels tended to have shorter pregnancies. The length of a pregnancy term may carry long-term implications on a babys health, the researchers suggest. This study reinforces a growing body of evidence suggesting that pesticide exposure in pregnancy may be correlated with gestational length, as well as adverse fetal growth, the paper says. Previous research has also linked glyphosate exposure to low birth weights. Growing exposure and potential consequences The women studied do not work in farming and no glyphosate was present in their water, suggesting that either inhalation of glyphosate or dietary exposure is the potential culprit, the researchers write. Their findings have implications for the entire country, as a study last year out of the University of California, San Diego found that human exposure to glyphosate has increased 500 percent in recent years. "Our exposure to these chemicals has increased significantly over the years but most people are unaware that they are consuming them through their diet, University of California public health professor Paul J. Mills said last year. Concerns about eating foods contaminated with glyphosate has spurred the organic food industry to advertise that their products have no-GMOs or no genetically modified ingredients. A separate campaign running across the country seeks to require labeling on all foods that do contain genetically modified ingredients. Vermont was the first state in the nation to mandate such labeling under a law passed in 2014. But in 2016, shortly after Vermonts labeling law went into effect, Sen. Mitch McConnell fast-tracked a bill in Congress that banned states from mandating labels on bioengineered food. Despite a warning from the Food and Drug Administration that preempting state labeling laws was a legally risky move, former President Barack Obama signed the legislation shortly after, essentially overturning Vermonts labeling law. Cancer warnings pulled in California The food and agriculture industry, as well United States regulators, have long pushed back on the idea that glyphosate has any ill health effects. The World Health Organization's International Agency for Research on Cancer caused a major controversy in 2015 when it published research claiming that glyphosate is a probable carcinogen. The state of California responded with plans to place ca[...]



Bankruptcies caused by health problems aren’t as common as previously thought

Thu, 22 Mar 2018 14:56:55 +0000

However, lost employment and lower earnings were connected to health problems By Sarah D. Young of ConsumerAffairs March 22, 2018 Medical bills can put a strain on a patients financial well-being, but bankruptcies due to medical bills arent as common as previous research suggests. A new study finds hospitalizations are to blame for only about 4 percent of personal bankruptcies among non-elderly adults in the U.S. Previous research yielded a commonly cited figure that 60 percent of bankruptcies have medical causes. However, researchers say previous estimates were drawn from self-reported data about health issues among those who filed for bankruptcy and did not establish that medical costs were the main cause of those bankruptcies. Hospitalizations lead to workplace troubles The new study tracked the credit reports of more than a half million adults over age 25 in California who had a hospitalization between 2003 and 2007 that wasnt tied to childbirth. Researchers found that hospitalizations did force some patients into bankruptcy in the years following their stay, but it didnt happen as often as past research indicated. The researchers pegged the figure at 4 percent. The new statistic takes into account multiple negative economic consequences of having medical problems, including a 20 percent drop in earnings and an 11 percent drop in employment for adults between ages 50 and 59 who had been hospitalized. The current study underscores the need to understand the full range of financial challenges people face due to their medical needs, the researchers said. "It doesn't mean there aren't really adverse economic consequences from adverse health," said co-author and MIT economist Amy Finkelstein. "It just turns out they're not [strictly] about bankruptcy. They're much more about lost employment and earnings." Not common among the elderly The study also found that bankruptcies caused primarily by medical problems are minimal among the elderly (those over 64). Elderly patients are more likely to have the aid of Medicare and retirement working in their favor, the researchers said. Finkelstein and her colleagues believe health problems often lead to workplace problems, which in turn leads to bankruptcy. "We suspect what's driving the [level of] bankruptcy we find is the fact that some people lose their job because of adverse health, and in turn that causes them to go bankrupt," Finkelstein said. "That's just not going to [apply to] the elderly, because they're not working, so they don't have the labor market risk from poor health." More research needed The study authors acknowledged that the current study had limitations. It focused only on adult patients from one state who were hospitalized. Additionally, it didnt look at other kinds of medical costs that drive people to bankruptcy (such as medical costs incurred by parents, children, or other relatives). "We're not going to go to the mat over the idea that [the rate of medically caused bankruptcies] is always going to be 4 percent in every context and by every measurement," Finkelstein says. Still, she added, the number of bankruptcies caused by medical problems is likely much lower than previous estimates indicate. The full study has been published online in the New England Journal of Medicine. [...]



Splenda worsens symptoms of Crohn’s disease, study finds

Wed, 28 Mar 2018 14:00:43 +0000

Researchers say Splenda induces changes in gut bacteria and gut wall immune cell reactivity By Sarah D. Young of ConsumerAffairs March 19, 2018 A new study suggests that Splenda and other zero-calorie sugar substitutes can worsen gut inflammation, which is a symptom of Crohns disease. Researchers from Case Western Reserve School of Medicine found that mice with Crohns-like diseases who drank water with Splenda had greater numbers of Proteobacteria or microbes that include pathogens, such as E. coli and salmonella, in their intestines compared to mice fed plain water. Mice without the condition were not affected by sucralose (which goes by the brand name Splenda), the six-week long study revealed. Induces biological changes In addition to intensifying gut inflammation, researchers found that mice models who consumed the artificial sweetener had increased activity of the enzyme myeloperoxidase. Myeloperoxidase is an enzyme in leukocytes (white blood cells) that attacks disease-causing microorganisms. Our findings suggest that patients with Crohns disease should think carefully about consuming Splenda or similar products, Alex Rodriguez-Palacios, study author and assistant professor of medicine at Case Western Reserve University, said in a statement. The study showed that the sweetener induces changes in gut bacteria and gut wall immune cell reactivity, which could result in inflammation or disease flare-ups in susceptible people. "On the other hand, the study suggests that individuals free of intestinal diseases may not need to be overly concerned, Rodriguez-Palacios said. Next steps Splenda, which includes sucralose and a digestible sweetener called maltodextrin, is about 600 times as sweet as sugar. The researchers say the study on animal models is perhaps the closest we can get to provide experimental evidence that these ingredients together induce biological changes known to cause inflammation which could be harmful over time to susceptible animal subjects. "Our next step would be to run experiments directly in patients, but that is more difficult to conduct given the large variability that is inherent to human genetics, microbiome and diet, Rodriguez-Palacios said. Crohn's disease is an inflammatory bowel disease of the digestive tract, which can cause symptoms including abdominal pain, severe diarrhea, weight loss, and fatigue. Around 1.3 percent of adults in the U.S. have inflammatory bowel diseases like Crohns disease, according to statistics from the U.S. Centers for Disease Control and Prevention. The full study has been published in the journal Inflammatory Bowel Diseases. [...]



Bottled water fans are ingesting small pieces of plastic, report says

Wed, 28 Mar 2018 14:00:04 +0000

The World Health Organization is now investigating bottled water over concerns of microplastic contamination By Amy Martyn of ConsumerAffairs March 16, 2018 The extraordinary saga of Evian bottled water, according to the Danone Corporation, began in France in 1789, when the Marquis de Lessert drank spring water from the Evian-les-Bains. His kidney stones were suddenly cured,, the town became famous, and over two centuries later, Evian has made billions selling bottled water with marketing campaigns centered on health, purity and eternal youth. Evian is now one of the pricer brands of bottled water on store shelves and the third largest bottled water company in the world. But a new study has once again cast doubt on the image of fresh, natural springs promoted by the bottled water industry and brands like Evian. Sherri Mason, a chemist and researcher at the State Univeristy of New York at Fredonia, tested 259 brands of bottled water for plastic particles. She and a team of researchers found widespread contamination, according to a report published by the school's environmental sciences program. Of the 259 total bottles analyzed, 93% showed signs of microplastics, the report says. Contaminated bottles included leading, well-known brands such as Evian, Aquafina, Dasani, Nestle Pure Life, and San Pellegrino, the report says. Plastic particles in bottled water The research was commissioned by Orb Media, a nonprofit journalism organization that has launched several investigations into the impact of plastic particles on consumer health and the eco-system. The researchers and Orb Media both say that the health effects of ingesting microscopic pieces of plastic are unknown. To conduct the study, researchers spent three months filling the water bottles with a dye that makes plastic fluorescent when irradiated with blue light. They say their findings suggest that the plastic is coming from the actual bottling process. I think that most of the plastic that we are seeing is coming from the bottle itself, it is coming from the cap, it is coming from the industrial process of bottling the water, Mason told the AFP. Bottled water probably no better than tap water Environmental advocacy groups have for years been trying to convince consumers to ditch bottled water altogether, citing the harmful effect that plastic waste has on the oceans, the potential human rights abuses in towns where water is sourced, and research showing that some bottled water may essentially be the same as filtered tap water. Bottled water is a $100 billion industry, outpacing any other sector of the beverage industry. An investigation last year by Bloomberg News found that Nestle had made its bottled water operations so profitable by sourcing from economically depressed areas for next to nothing -- or in the case of one town in Michigan, just $200. The bottled water industry has responded to such criticisms with campaigns to reshape their public image. Nestle, Coca-Cola and Veoli have partnered with the World Bank in an attempt to transform the water sector, as they put it, and Evian recently announced that its bottles will be produced from 100 percent recycled plastic by 2025. Small fragments of plastic have also been found in everything from seafood to regular old tap water, and totally avoiding the ingestion of plastic is likely an impossible task for most modern consumers. But Mason said that the concentration of plastic particles in bottled water was higher than even plastics detected in tap water. According to a previous report by University of Wisconsin-Madison scientist Barbara Ingham, bottled water is probably not any better than most tap water, and tap water is cer[...]



White House reportedly to propose death penalty for opioid drug dealers

Thu, 12 Apr 2018 14:36:46 +0000

A report suggests tougher penalties are included in the latest plan to fight addiction

By Mark Huffman of ConsumerAffairs
March 16, 2018

(image) The Trump administration has reportedly drawn up a plan to fight opioid addiction that includes the death penalty for drug dealers, in some cases.

In an exclusive report, Politico cites internal documents that it says have circulated among administration officials in recent weeks. It says the plan calls for new treatment and preventive measures sought by many public health officials, but it also takes a harder line on law enforcement.

The report drew a strong reaction from some Democrats. Sen. Edward Markey (D-Mass.) released a statement, saying the report -- if true -- would be a major misstep in dealing with the opioid epidemic.

We will not incarcerate or execute our way out of the opioid epidemic, Markey said. We are still paying the costs for one failed War on Drugs, and now President Trump is drawing up battle plans for another.

'Extreme proposals'

Markey warned that enacting what he called "extreme proposals" would backfire, perpetuating a stigma associated with opioid use disorders.

"Patients and families suffering in this opioid crisis dont need toughness, they need treatment," Markey said.

The White House has not commented on the report, but Politico says the President could announce his plan early next week when he is scheduled to visit New Hampshire, a state hard hit by opioid abuse.

Other features of the reported plan

According to the Politico report, the administration plan would change how government agencies pay for opioid drugs as a way to limit access. It would also recommend to Congress changes in the Medicaid law to make it easier for people addicted to the painkillers to get treatment.

There were more than 63,000 drug overdose deaths in the U.S. in 2016, according to the Centers for Disease Control and Prevention (CDC). A large number occurred in rural New England states.

Late last month, the state of Maine reported it suffered 418 drug-induced deaths in 2017. Drug overdose deaths increased by 11 percent in 2017, driven by a sharp increase in deaths due to illegal fentanyl and fentanyl analogs. At the same time, heroin deaths decreased.




FDA announces intent to lower nicotine levels in cigarettes

Fri, 16 Mar 2018 16:06:31 +0000

The proposed move would drastically reduce the number of tobacco-related deaths By Sarah D. Young of ConsumerAffairs March 16, 2018 The Food and Drug Administration (FDA) announced Thursday that it is taking a historic step toward making cigarettes less addictive. The agency is considering limiting the amount of nicotine it will allow in cigarettes to 0.3, 0.4, or 0.5 milligrams of nicotine per gram of tobacco filler. For context, most regular cigarettes contain about 10 to 14 mg of nicotine. Cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users, FDA Commissioner Scott Gottlieb said in statement, noting that 480,000 Americans die every year due to tobacco-related causes. 8 million fewer deaths An FDA-funded analysis found that reducing nicotine levels could lower the smoking rate from 15 percent of adults to just 1.4 percent, which would result in around 8 million fewer tobacco-related deaths by the end of the century -- an undeniable public health benefit, Gottlieb said. Under the Family Smoking Prevention and Tobacco Control Act, the FDA is legally prohibited from completely eliminating nicotine from cigarettes. Mitch Zeller, director of the FDAs Center for Tobacco Products, said cutting nicotine levels would reduce their addictive power over individuals, which would help more adults succeed in quitting smoking. It could also potentially help keep young people who may be experimenting with smoking from becoming addicted. The nicotine notice follows Gottliebs announcement last summer that the FDA would pursue a comprehensive plan on tobacco and nicotine regulation in an effort to prevent millions of tobacco-related deaths. Open for public comment The notice will be open for public debate for 90 days. During that time, the agency is seeking input on what maximum nicotine level would best protect the publics health and whether a new limit should be implemented gradually or all at once. Gottlieb is also seeking opinions on whether addicted smokers would compensate by smoking more or create a black market for high-nicotine cigarettes. Its critical that our policies reflect the latest science and is informed by the input we receive from groups and individuals with a stake in the outcome, he added. [...]



Fitbit introduces its new smartwatch and kid-oriented health tracker

Wed, 14 Mar 2018 13:55:11 +0000

The new devices focus on womens health and childrens physical well-being By Gary Guthrie of ConsumerAffairs March 14, 2018 Fitbit has expanded its wearable tech product line, jumping into the kids exercise tracking game and amping up its run at the smartwatch market. Fitbit Ace is the companys new activity tracker designed for kids 8 and older. The unit tracks the same activities that traditional trackers do like steps and sleep, but it comes with a family account where parents can monitor activity and control who their kids connect with in the Fitbit app. The kid-oriented tracker was developed out of a Fitbit research study that found most parents believe their children are less active than they were when growing up. Add to that the concerns about their childs weight, the foods they eat, and the universal worry over child obesity. As childhood obesity rates continue to rise, its more important than ever to empower the entire family to embrace a healthy and more active lifestyle, said James Park, CEO and Co-founder of Fitbit. It can be hard to start and stick to good habits, and we know from our community that network effects are key to getting and keeping people motivated. By bringing that experience to families, it can make healthier habits feel more achievable by making it fun and engaging. Fitbit Ace is priced at $99.95. Its available for presale on the companys website and expected in stores in the next three months. A smartwatch designed with women in mind The companys newest foray into the smartwatch market comes in the form of its smartphone-compatible Fitbit Versa. Fitbit claims that the unit will come with a simpler activity-tracking dashboard and enhancements such as on-screen workouts and on-device music. The company also says it will be the lightest smartwatch available on the market. Part of the Versas appeal is its intuitive personalization that takes cues from the wearers activities. Prompts include reminders, celebrations, sleep summaries, and challenges from a users social media network. One of the comparative advantages Fitbit is banking on for the Versa is its female focal point. The new device is designed to track menstrual cycles and keep tabs on a wearers holistic data. A recent Fitbit study found that there was a profound lack of awareness about womens health. Eighty percent of the women surveyed did not know how many phases are in a menstrual cycle and more than 70 percent were unable to correctly identify the average length of a cycle. The smartwatch market continues to grow The companys smartwatch launch couldnt come at a better time for its investors. The worldwide wearables market continues to grow and holds great promise. In the third quarter of 2017 total shipment volume reached 26.3 million units, up 7.3 percent year-over-year, according to the International Data Corporation (IDC). "The differing trajectories for both smart and basic wearables underscore the ongoing evolution for the wearables market," said Ramon T. Llamas, research manager for IDCs Wearables team. "Basic wearables with devices coming from Fitbit, Xiaomi, and Huawei helped establish the wearables market. But as tastes and demands have changed towards multi-purpose devices like smartwatches from Apple, Fossil, and Samsung vendors find themselves at a crossroads to adjust accordingly to capture growth opportunity and mindshare." The Fitbit Versa is available for presale today at $199.95, with global retail availability coming in April 2018. [...]



Things to watch out for on a spring break beach vacation

Mon, 12 Mar 2018 20:00:32 +0000

Contaminated water is just one concern

By Mark Huffman of ConsumerAffairs
March 12, 2018

(image) If you're headed to the beach for spring break, checking out the condition of the water before your arrive is not a bad idea.

TexasBeachWatch.com, a site operated by the State of Texas, rates the states beaches according to their cleanliness. Recently, it listed a handful of public beaches along the Gulf Coast as having higher-than-normal amounts of fecal matter in the water.

Specifically, the website listed Corpus Christi Bay and North Padre Island as having significant amounts of fecal bacteria. The site also notes a rise in contamination at Freeport, Matagorda Bay, and along the Galveston coast. You can check out current pollution levels here.

The State of Florida also maintains a close watch on its water quality. Florida Health has an online tool where vacationers can check the most recent water quality at hundreds of the state's beaches.

Health risks

Swimming in contaminated water carries obvious health risks. The Environmental Protection Agency (EPA) says untreated sewage can get into the ocean in a variety of ways. It can come through runoff from heavy rains, washing animal wastes into the water, as well as inadequate sewage treatment facilities.

When it does, it can expose swimmers to microorganisms called pathogens that can make swimmers sick. The most common illness is gastroenteritis. Its symptoms include nausea, vomiting, stomachache, diarrhea, headache, and fever.

Swimmers who come down with ear, eye, nose, and throat infections may have also come in contact with polluted water.

Other threats

Spring break vacationers headed for the beach should also remember that illness isn't the only thing that could spoil a vacation. Waves and water currents in the ocean are very different from other bodies of water and require heightened awareness.

In particular, the Red Cross warns beachgoers to be aware of rip currents that can carry even strong swimmers very far offshore. Rip currents are not easy to spot and can form in low spots and breaks in sandbars, or near structures such as jetties and piers.

While swimming on a public beach, it is always a good idea to do so in water close to a lifeguard. Children and inexperienced swimmers should also always wear a flotation device while in the water.




Accidental discovery could prompt new treatment for multiple sclerosis

Wed, 21 Mar 2018 13:40:46 +0000

Researchers believe targeting a specific brain protein could help consumers build a resistance By Christopher Maynard of ConsumerAffairs March 9, 2018 Its not uncommon for medical discoveries to be made completely on accident. In 1928, Scottish physician and microbiologist Alexander Fleming came back from holiday and found that a spot of mold in one of his petri dishes had inhibited the growth of a colony of Staphylococcus that he was testing. The discovery would eventually lead to the development of penicillin. Now, researchers from the University of Alberta and McGill University may have accidentally discovered a new means of treating multiple sclerosis (MS). While studying human brain tissue, the team inadvertently found that samples from people who had the neurodegenerative disease had high levels of a protein called calnexin. The finding prompted further study using mice. The researchers found that subjects that lacked the protein were completely immune to MS. The team believes that controlling levels of calnexin could be a viable pathway for a new treatment. We think this exciting finding identifies calnexin as an important target for developing therapies for MS, said Luis Agellon, a professor and researcher at the McGill School of Human Nutrition. Unlocking the secret of treating MS Up until now, the researchers say that treating MS has been difficult because its causes are not well understood. However, they believe that high levels of calnexin could explain how the disease makes its way to the brain and causes damage. It turns out that calnexin is somehow involved in controlling the function of the blood-brain barrier, explains Marek Michalak, a biochemistry professor at the University of Alberta. This structure usually acts like a wall and restricts the passage of cells and substances from the blood into the brain. When there is too much calnexin, this wall gives angry T cells access to the brain, where they destroy myelin. The results of a 2016 study estimate that MS affects nearly 400,000 people in the U.S. and approximately 2.1 million people worldwide. Healthcare costs can range from just over $8,500 per patient to over $52,000 per patient depending on the severity and progression of the disease. The researchers believe their finding could lead to a treatment that helps stop the disease in its tracks. Our challenge now is to tease out exactly how this protein works in the cells involved in making up the blood-brain barrier. If we knew exactly what calnexin does in this process, then we could find a way to manipulate its function to promote resistance for developing MS, said Agellon. The full study has been published in JCI Insight. [...]



Cigna to buy Express Scripts for $67 billion

Thu, 08 Mar 2018 17:25:35 +0000

The companies say the merger will give more options to consumers and reduce costs

By Mark Huffman of ConsumerAffairs
March 8, 2018

(image) Health insurance provider Cigna has announced it is acquiring pharmacy benefits manager Express Scripts for $67 billion, continuing the trend of consolidation within the healthcare industry. The move, following on the heels of Aetna's merger with CVS Health, could lower costs for consumers, at least in theory.

Because prescription drugs are a major cost driver in healthcare, the combination of medical claims and pharmacy under one roof has the potential to create cost-lowering efficiencies. It also gives the merged companies more bargaining power when it comes to negotiating drug prices.

David Cordani, Cigna's CEO, believes the merger will improve quality and increase affordability for consumers.

This combination accelerates Cignas enterprise mission of improving the health, well-being and sense of security of those we serve, and in turn, expanding the breadth of services for our customers, partners, clients, health plans and communities," Cordani said.

Cordani says the combined enterprises will expand the health services that are provided, deliver greater consumer choice, and deliver more personalized value, which will create significant benefits to society and differentiated shareholder value.

What it could mean

The two companies say the merger would lead to a full suite of medical, behavioral, specialty pharmacy, and other health engagement services to give customers more options when it comes to their healthcare.

The two companies also say the combination would be a means to provide greater alignment and interaction between patients and their healthcare providers. The goal, the companies say, is to reduce complexity and create better outcomes.

If the merger is finalized, the combined companies will operate under the name Cigna and be based at Cigna's current corporate headquarters in Bloomfield, Connecticut.

Cigna and Express Scripts are in complementary, not competing businesses. Cigna offers various health insurance policies to consumers. Express Scripts is a pharmacy benefit manager (PBM) that administers prescription drug programs for a wide variety of clients, from health insurers to government agencies.

The merger still must get a green light from government regulators. A year ago, regulators blocked Cigna's attempt to purchase rival health care provider Anthem.




Aggressive blood pressure standards may be harmful, researchers say

Wed, 21 Mar 2018 13:40:11 +0000

The debate over what constitutes high blood pressure is being renewed By Mark Huffman of ConsumerAffairs March 8, 2018 Researchers at theFeinstein Institute for Medical Research say new blood pressure guidelines, that have lowered targets for blood pressure readings, may be causing more harm than good, at least for many patients. Writing in the Journal of the American College of Cardiology, Dr. Joseph Diamond and colleagues conclude that as many as 10 million people receive unnecessarily aggressive blood pressure treatments. What constitutes high blood pressure has been somewhat controversial for a decade or more. Medical groups have lowered the threshold for hypertension, or high blood pressure, from a reading of 140/90 to 130/80. Under the new guidelines, a reading of 120/80 is considered healthy. After much debate and research, the new guidelines were formalized last year and backed by the American Heart Association, American College of Cardiology, and nine other professional health organizations. But the lower threshold now means 46 percent of American adults -- up from 32 percent previously -- are now considered hypertensive and in need of prescription medication. 'Not warranted in all individuals' The Feinstein Institute researchers concluded that people at higher risk of cardiovascular disease could benefit from the lower blood pressure threshold, but they say patients at low risk might actually suffer harm. "After looking at data, my colleagues and I recommend using a different model for patients with high blood pressure than what was most recently recommended," Diamond said. "Identifying patients by degree of future cardiovascular risk identifies those who will most benefit from intensive blood pressure treatment goals. We do not feel that aggressive blood pressure lowering is warranted in all individuals." Based on a 10-year cardiovascular disease risk, the researchers conclude that aggressively trying to lower blood pressure in patients with a risk greater than or equal to 18.2 percent would be mostly beneficial. However, those with less risk would be better off using the previous blood pressure management approach. Recent controversy This is not the first time the medical community has questioned aggressively low blood pressure standards. In 2014, researchers at Wake Forest Baptist Medical Center reported that lowering systolic blood pressure below 120 did not appear to provide additional benefit for patients. Frequently we treat patients blood pressure to the lowest it will go, thinking that is whats best, lead author Carlos J. Rodriguez, M.D., said at the time. Earlier that year, Duke University researchers ran an analysis and concluded that a proposal to ease the guidelines, and thereby raising the threshold of acceptable blood pressure to previous levels, would mean an estimated 5.8 million adults no longer needed blood pressure medicine. [...]



FDA approves 23andMe test to evaluate cancer risk

Wed, 07 Mar 2018 17:14:41 +0000

The test can report on genetic risk for breast, ovarian, and prostate cancer, but there are limitations

By Sarah D. Young of ConsumerAffairs
March 7, 2018

(image) The U.S. Food and Drug Administration (FDA) hascleared 23andMe to launch a direct-to-consumer DNA test for gene mutations connected to various forms of cancer.

The test, which will be made available without a prescription, will provide information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian, and prostate cancer.

"We believe its important for consumers to have direct and affordable access to this potentially lifesaving information. We will continue pioneering a path for greater access to health information and promoting a more consumer-driven, preventive approach to health care," said Anne Wojcicki, CEO and co-founder of 23andMe.

Not a replacement for screening

The FDA calls the test a step forward in the availability of DTC genetic tests, but emphasized that there are a lot of caveats.

The three DNA mutations searched for in the screening make up a small percentage of hundreds of known BCRA mutations. The variants are found most commonly in people of Ashkenazi Jewish descent -- they are not the most common BRCA1/BRCA2 mutations in the general population, the FDA said in a statement.

The agency stressed that this test should not be used as a replacement for a visit to the doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.

"Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions," the National Society of Genetic Counselors (NSGC) told NBC News.

"Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results, said Erica Ramos, the group's president.




New HIV drug wins FDA approval

Wed, 07 Mar 2018 14:31:29 +0000

Trogarzo is for patients who are running out of options

By Mark Huffman of ConsumerAffairs
March 7, 2018

(image) The Food and Drug Administration (FDA) has approved a new drug to treat HIV patients who have not responded to other therapies and who have limited treatment options.

Trogarzo, with the generic name ibalizumab-uiyk, is an antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past. Specifically, the drug will be given to a small percentage of patients -- estimated to be around 1 percent -- whose HIV infections cannot be successfully treated with other currently available drugs.

Jeff Murray, M.D., deputy director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research, says this small number of HIV patients, who have been treated with a combination of drugs, can build up a resistance which reduces the effectiveness of drugs they may take for their condition.

"Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options," Murray said. "New treatment options may be able to improve their outcomes."

Trogarzo will be administered in the form of a shot once every 14 days by a trained medical professional. It can also be used in combination with other antiretroviral medications without losing its effectiveness.

Promising results in clinical trials

The FDA says Trogarzo was proven safe and effective in clinical trials that enlisted 40 patients who continued to have very high levels of the HIV virus in their blood despite being on current antiretroviral drugs.

Most of the patients experienced a significant decrease in their HIV-RNA levels one week after Trogarzo was added to their treatment. After 24 weeks of Trogarzo, plus other antiretroviral drugs, 43 percent of the trial's participants saw their HIV RNA levels drop.

The most common adverse side effects to Trogarzo were diarrhea, dizziness, nausea, and rash. Severe side effects included rash and changes in the immune system, a condition called immune reconstitution syndrome.




Child opioid overdoses have nearly doubled since 2004

Thu, 08 Mar 2018 04:50:18 +0000

Researchers say kids are becoming second victims in the adult opioid epidemic By Sarah D. Young of ConsumerAffairs March 5, 2018 The number of children hospitalized for opioid overdoses has doubled since 2004, a new study published in Pediatrics finds. For the study, researchers at the University of Chicago Medicine Comer Childrens Hospital looked through the Pediatric Health Information System (PHIS), which records the most serious overdose cases. They found that from 2004 to 2015, 3,647 children across 31 hospitals were admitted to pediatric intensive care units with opioid-related diagnoses. The number of hospitalizations requiring intensive care nearly doubled between 2012 to 2015, rising from 797 patients between 2004 and 2007 to 1,504 patients during the most recent time frame analyzed. Accidental consumptions common The majority of the overdoses involved children between 12 and 17 years old, but one-third of cases involved children under the age of six Even in children under 6 years old, opioids now account for the majority of drug poisonings, the researchers wrote in their report. In this study, we demonstrate a significant and steady increase in the diagnosis of opioid ingestion and poisoning across all age groups in U.S. childrens hospitals from 2004 to 2015. Not only did the absolute number of opioid-related admissions increase, but the rate of both hospital and PICU admissions increased as well. The study didnt differentiate between kids who ingested prescription painkillers or other opioids intentionally and those who did so accidentally. However, the researchers said many overdoses in children under six were probably caused by kids finding their parents prescribed and non-prescribed medications. Safely using medication "I think there needs to be a stronger emphasis to the adults receiving these drugs -- these prescription medications -- about the consequences that may happen to their families as a result of those drugs being in their homes," lead author Dr. Jason Kane told CNN. Parents taking these substances are advised to take preventative measures, such as using a lockbox to store the medication. If they are expired or no longer being used, experts recommend taking them to a pharmacy or a facility that can appropriately dispose of them. Current efforts to reduce prescription opioid use in adults have not curtailed the incidence of pediatric opioid ingestion, and additional efforts are needed to reduce preventable opioid exposure in children, the authors wrote. Around 2 million Americans have an opioid use disorder, according to federal estimates. That includes abuse of prescription painkillers such as Vicodin and OxyContin, as well as illegal drugs like heroin. [...]