Current Events in March 2019

The Food and Drug Administration (FDA) has approved a new generic version of the blood pressure drug valsartan, which is also sold under the trade name Diovan. Valsartan is a widely used angiotensin II receptor blocker (ARB) that doctors prescribe for high blood pressure and heart failure.

The approval was placed on the FDA fast track after the agency confirmed the presence of an impurity in several lots of the medicine last year. Researchers detected a trace amount of an unexpected impurity -- N-nitrosodimethylamine (NDMA). NDMA has been classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC).

The discovery led to major recalls of existing forms of valsartan, which in turn led to shortages of the drug.

“To address the public health consequences of these shortages, we've prioritized the review of generic applications for these valsartan products,” said FDA Commissioner Scott Gottlieb. “When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients. As part of that work, we look at where we may be able to prioritize review of pending generic applications of the medicine in shortage, or similar products.”

Gottlieb said he is hopeful the approval of the new generic will quickly alleviate the valsartan shortage. Meanwhile, he says the FDA will step up its efforts to keep impurities out of approved prescription drugs.

Suspected human carcinogen

Valsartan began disappearing from pharmacies in the middle of last year after a Chinese company reported the presence of NDEA in several batches of its valsartan API. It was of special concern since NDEA is a suspected human carcinogen.

The FDA began its tests after the Chinese report and resulting recalls. The FDA probe, completed in September, not only found the impurity in the Chinese company's product, but also in Torrent Pharmaceutical’s valsartan 160mg (lot BV47D001) and 320mg (lots BV48D001 and BV48D002) tablets.

The discovery of a potential carcinogen in a prescription drug may well have been a wakeup call for the agency, It says it has conducted a major investigation to address the presence of nitrosamine impurities in certain generic ARB products.

The FDA says it has also worked with companies to move quickly to remove any products with unacceptable impurities from the U.S. market.

Consumers who spend their days in an office also spend most of their days sitting. But with many workplaces implementing sit-stand desks (SSDs), consumers may be able to reverse that trend.

Researchers from the University of Pittsburgh are currently exploring how consumers can make the most of their sit-stand desks, as much recent research has presented conflicting evidence.

“There has been a great deal of scientific research about sit-stand desks in the past few years, but we have only scratched the surface of this topic,” said Dr. April Chambers. “With my background in occupational injury prevention, I wanted to gather what we know so far and figure out the next steps for how we can use these desks to better benefit people in the workplace.”

Staying standing

Dr. Chambers and her team evaluated over 50 recent studies that examined the ins and outs of sit-stand desks to see how they affected consumers on several different levels: posture, work performance, behavior, discomfort, psychological, and physiological.

According to fellow researcher Dr. Nancy A. Baker, the studies proved that the “strongest changes” were seen in behavior and discomfort, while “the study found only minimal impacts” on any of the other potential factors.

Based on the studies, many sit-stand desk users were disappointed that the device didn’t help them shed excess weight.

According to the researchers, SSDs were initially touted as a tool to aid in fighting obesity, as it would get workers out of their chairs more. While they were effective to that end, and in giving consumers the freedom to move around and be more comfortable during their workdays, losing weight was not a factor here.

Though not effective in tackling obesity, the researchers did note that sit-stand desks were helpful to consumers’ health in that they aided in easing lower back pain and even incrementally lowered blood pressure.

“Though these are mild benefits, certain populations might benefit greatly from even a small change in their health,” said Dr. Chambers.

The researchers want to encourage workplaces to provide their employees with proper training and direction to not only properly use their sit-stand desks, but ensure that doing so will leave them with as many benefits as possible.

“Many workers receive sit-stand desks and start using them without direction,” Dr. Chambers said. “I think proper usage will differ from person to person, and as we gather more research, we will be better able to suggest dosage for a variety of workers.”

The researchers note that there are many factors at play, including how much time is spent standing, how tall consumers’ computers are, how tall their desks are, and if consumers were properly trained in how to operate their SSDs. Ticking off each of those factors would allow consumers to maximize the benefits.

Conflicting advice

While Dr. Chambers and her team are adamant that employees can benefit from their SSDs with the proper training, much of the previous research done on the topic has been conflicting.

While some researchers have found negative consequences associated with prolonged sitting, others have found risks associated with prolonged standing. However, one study suggests that working standing up could be the best thing for consumers’ production. That study focused entirely on work outcomes and found that completing assignments while standing led to much stronger cognitive abilities.

“Test results indicated that continued use of standing desks was associated with significant improvements in executive function and working memory capabilities,” said Ranjana Mehta, PhD. “Changes in corresponding brain activation patterns were also observed.”

AurobindoPharma USA and Acetris Health are expanding an earlier recall of Valsartan and Amlodipine and Valsartan tablets, which are used to control high blood pressure and for the treatment of heart failure.

Trace amounts of an unexpected impurity, N-nitrosodiethylamine (NDEA) -- a probable human carcinogen – have been found in the product.

The following products, packaged in bottles, are being recalled:

The recalled products were distributed nationwide.

What to do

Patients should continue taking their medication, as the risk of harm to their health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

AurobindoPharma is notifying its customers by phone and in writing and arranging for return of all recalled products. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall may contact AurobindoPharma at (866) 850- 2876, Option 2 or by email at pvg@aurobindousa.com.

The New York state legislature will consider a measure banning the sale of dogs, cats, and other animals at pet stores within the state.

Assemblymember Linda B. Rosenthal, who sponsored the bill, said the measure is aimed at ending what she called the “puppy mill to pet store pipeline.”

"Unsuspecting customers pay hundreds of dollars for a cute puppy or kitten, only to find that the animal is incurably sick,” Rosenthal said. “Our animal shelters and rescue organizations are overflowing with animals needing forever homes; it's time we start connecting rescue animals with loving homes through adoption in pet stores."

The American Society for the Prevention of Cruelty to Animals (ASPCA) says many breeding operations overproduce dogs, targeting consumers who desire a “pure breed” pet. But the group says unhealthy conditions in the mills, combined with genetic weaknesses, often produce offspring with a very short lifespan.

Previous measure

New York has had puppy mills in its sights for some time. In 2017, a federal appeals court upheld a New York City statute intended to curb puppy mills. That ordinance requires that pet shops only sell dogs and cats from Class-A-licensed breeders who have not had their licenses suspended in the last five years.

The Assembly bill takes it a step farther and extends the prohibition throughout the state. Bill Ketzer, senior director of state legislation for the ASPCA, Northeast region, says the legislation may be the only way to end pet over-breeding within the state.

"Time after time, the pet industry has demonstrated that it is not interested in ensuring the welfare of the dogs it churns out, nor is it interested in transparency or public accountability," Ketzer said. "These badly regulated commercial dog breeders have only one goal: breed the highest volume of puppies possible at the lowest cost for the retailer.”

Ketzer says there have been cases where pet stores look the other way and exclude well-documented health and behavior risks in their pitch to buyers, who believe they are going home with a healthy, well-bred puppy.

The Humane Society of the United States has also thrown its support behind the measure. Brian Shapiro, New York state director for the group, says it’s up to states to take action because “federal regulators fail to provide proper oversight of large-scale pet breeders."

The Federal Aviation Administration (FAA) has declined to ground U.S.-based Boeing 737 Max 8 jets in the wake of the second fatal crash of the aircraft in five months. However, some other countries have taken that step.

Chinese regulators have ordered the country’s domestic airlines to suspend all 737 Max operations. Cayman Airways is also among the international carriers that have grounded the 737 Max 8 aircraft until more details are known about Sunday’s crash of an Ethiopian Airlines jet that killed all on board.

In a notice issued late Monday, the FAA said the 737 Max aircraft type is airworthy, but then went on to say that it expects it will require Boeing to make design changes to some of the aircraft’s systems no later than next month.

The FDA reacted in the wake of widespread concern because Sunday’s crash of an Ethiopian Airlines Boeing 737 Max 8 came just five months after a Lion Air Max 8 also crashed on takeoff.

Investigation just beginning

“External reports are drawing similarities between this accident and the Lion Air Flight 610 accident on October 29, 2018,” the FAA said in its notice. “However, this investigation has just begun and to date, we have not been provided data to draw any conclusions or take any actions.”

The FAA’s decision drew immediate criticism of Paul Hudson, president of the consumer group FlyersRights.org.

"The FAA's 'wait and see' attitude risks lives as well as the safety reputation of the US aviation industry,” Hudson said. “Even assuming this design defect should not by itself take the aircraft out of service, the failure to warn airlines and pilots of the new feature, and the inadequacy of training requirements, necessitate an immediate temporary grounding of the Boeing 737 MAX 8."

In the United States, American and Southwest fly some of the 737 Max 8s. United flies a larger version of the aircraft, the 737 Max 9.

American operates 24 Boeing 737 Max 8s and the union representing American flight attendants issued a statement Monday saying that any flight attendants who are uncomfortable working on the aircraft can work on another flight.

In a statement to the media, American said it is working closely with regulatory authorities and “has full confidence in the aircraft.” Southwest Airlines, which flies 34 Max 8s, said it plans no changes in its operations because of Sunday’s crash.

"We have been in contact with Boeing and will continue to stay close to the investigation as it progresses," the company said in the statement.

Focus of the investigation

The investigation into Sunday’s crash is just beginning, but the Lion Air crash in October has focused attention on a new flight control system called MCAS. Though the investigation of the Lion Air crash is ongoing, investigators have suggested the system pushed the nose of the plane down when it was supposed to be climbing.

In the wake of the Lion Air accident, the FAA issued an Airworthiness Directive after an analysis by Boeing showed that “if an erroneously high single angle of attack (AOA) sensor input is received by the flight control system, there is a potential for repeated nose-down trim commands of the horizontal stabilizer.”

It not addressed, the FAA said that could cause the flight crew to have difficulty controlling the airplane, and lead to excessive nose-down attitude and significant loss of altitude.

Travelers booked on a flight can find out if their scheduled plane is a Boeing 737 Max 8 by entering the flight information here.

Volkswagen (VW) is stepping up its pace in the climate protection movement. The company says it wants to be part of the solution instead of part of the problem and, to prove it, is primed to produce 22 million electric vehicles across its entire product line over the next 10 years.

The automaker’s leader-like position could be just the thing environmentalists were hoping for in trying to get major companies to not just take notice, but actually do something enterprising in the fight against global warming.

“We are the first generation to understand climate change to its full extent, and the last one that can still do something about it,” said Petteri Taalas, Secretary-General of the World Meteorological Organization WMO, at a recent climate conference.

Taalas’ summary of the changes, however, had a rather dour tone. “We’re not on the path to meeting climate protection targets and limiting temperature rise.”

“Volkswagen has chosen to accept its responsibility and … over the next five years, Volkswagen will be investing around 30 billion euros (approximately $34 billion U.S.) in electric mobility,” the company said a blog post.

On the board are eight manufacturing facilities worldwide where VW will produce its new generation of electric cars while, at the same time, preparing for its exit from the production of non-CO₂-neutral vehicles. VW has gone on record saying the CO₂ problem is the biggest global challenge of them all.

“Volkswagen is taking on responsibility with regard to the key trends of the future – particularly in connection with climate protection,” Dr. Herbert Diess, CEO of Volkswagen AG, said at the company’s annual meeting.

“The targets of the Paris Agreement are our yardstick. We will be systematically aligning production and other stages in the value chain to CO2 neutrality in the coming years. That is how we will be making our contribution towards limiting global warming. Volkswagen is seeking to provide individual mobility for millions of people for years to come -- individual mobility that is safer, cleaner and fully connected. In order to shoulder the investments needed for the electric offensive we must make further improvements in efficiency and performance in all areas.”

What the pundits say

Electrek, a news site tracking the transition from fossil fuel transportation to electric and clean ecosystems, gave VW’s move its two cents worth:

“I know VW gets a lot of flak for always talking about its ambitious electric vehicle plans instead of delivering them, but they are coming people,” Electrek’s Fred Lambert wrote.

“What is important is that in the case of VW, we have seen them make a significant investment to convert gasoline and diesel vehicle production capacity to electric vehicle production capacity. That said, it won’t be an easy transition for Volkswagen. They have already run into a lot of troubles delivering the e-tron. It will be interesting to see how they handle those next few years.”

Which do consumers love most -- their trucks or a greener planet?

Like Lambert said, the next few years will be interesting. Audi and Porsche both have given e-vehicles the go-ahead and have those vehicles in various stages of development and production.

VW’s competitive salvo will no doubt be watercooler fodder at the “Big 3” automakers -- Ford, GM, and Fiat Chrysler. All have promoted an embrace of a greener future, but they have failed to completely follow through on that promise so far.

Part of that slacker attitude may stem from the messages consumers are sending the Big 3. American vehicle owners love trucks -- so much that automakers shifted in that direction, and with a great return on that investment. In 2018, light truck sales were more than double that of automobiles, according to Statista.

The Obama administration’s campaign to raise fuel efficiency standards to 54.5 mpg by 2025 went nowhere, and with gas prices normalized for the time-being, there’s simply not enough hand-wringing going on to force consumers to trade in their trucks for an electric vehicle.

“To meet the standards, some people would have to give up their trucks,” Wade Newton, a spokesman with the trade group Auto Industry Alliance told ConsumerAffairs. “I don't think people forecast that consumers would want (the number of) trucks that they have.”

The organization went on to say that it isn’t “greenwashing” its image with promoting electric vehicles.

Truck love or gas prices don’t seem to matter to VW. The company sees a very rosy economic upside in its long-term play and moving everything it does in that direction.

“The strategic goal of becoming the leading worldwide provider of e-mobility can make the focus on consistent decarbonization a strong competitive edge,” says Georg Kell, spokesman for Volkswagen’s independent sustainability advisory board. “In any case, it offers the best way for setting a common course for a secure and economically successful future on a planet worth living on.”

Microsoft has added a new feature to Windows 10 that will allow the operating system to automatically uninstall any updates that cause issues that are unable to be fixed.

In a recently published support document, Microsoft stated that some updates may be incompatible with a user’s system or contain other major bugs.

"Windows automatically installs updates to keep your device secure and running at peak efficiency. Occasionally, these updates can fail due to incompatibility or issues in new software,” Microsoft explained.

In those instances, users will see the following message: "We removed some recently installed updates to recover your device from a startup failure." After uninstalling the problematic update, Windows said it would restore the operating system to the “last good configuration.”

Users still have the ability to install updates manually if they believe that the updates shouldn’t have been removed. However, the system may still automatically reject the update in question if it prevents the computer from booting up properly.

In its announcement of the feature, the company also urged Windows users to help it diagnose and remediate updates that contain bugs by submitting feedback through the Windows 10 Feedback Hub app.

Chipotle Mexican Grill is expanding the availability of its Chipotle Rewards loyalty program following an initial launch in three pilot markets last fall, and it’s celebrating the expansion with a “free money” giveaway.

The program lets customers who order online or use the Chipotle app to earn 15 points for every $1 they spend and 10 points for every dollar spent in the restaurant. Once 1,250 points are accrued, customers are eligible for a free entrée. First-time users also get free chips and guacamole.

“In our test markets we’ve seen people get more engaged and more committed in our digital system with the loyalty program,” CEO Brian Niccol told CNBC. “We see people participating even more with delivery, mobile ordering and ordering within the app.”

Giveaway

For launch week, Chipotle is partnering with digital wallet company Venmo to deposit anywhere between $1 to $500 in user’s Venmo accounts through Friday, March 15. The burrito chain says it will give away up to $250,000 to approximately 25,000 customers.

Customers can enter to receive a reward by entering the phone number associated with his or her Venmo account on ChipotleRewardMe.com. Winners will receive a payment from Chipotle via Venmo within 24 hours of entering.

"Chipotle is one of the first brands to utilize Venmo's technology to engage with customers through this pay-out feature on the Venmo app," Chris Brandt, Chipotle's chief marketing officer, said in a statement.

"Our customers have been asking for a loyalty program for a long time and we're excited to partner with Venmo to reach their highly engaged network of digital-first customers to launch Chipotle Rewards, where the more you Chipotle, the more you can get free Chipotle,” Brandt added.

The wider rollout of the rewards program comes at a time when the company is trying to grow its digital offerings. In February, Chipotle announced that it’s testing “Chipotlanes,” drive-thru windows dedicated to pickup for mobile orders.

"You never have to get out of your car. You order from your app, pull up to the window and out comes Chipotle," Niccol said. "Arguably, it will be the fastest way to [get] Chipotle — going through the Chipotlane.”

Uber’s food delivery team is testing a service that rents out fully equipped, commercial-grade kitchens to businesses selling food through delivery apps like Uber Eats, according to Bloomberg.

An anonymous source with knowledge of the matter told the publication that Uber began leasing real estate in Paris last year.

“It (Uber) has been stocking the space with ovens, refrigerators, sinks, stoves and other appliances, and renting them out to restaurateurs planning eateries that cater exclusively to delivery customers,” Bloomberg said.

At this point, the program is still in its early stages and hasn’t been disclosed publicly. If it gets off the ground, Uber’s “virtual restaurants” project would directly compete with a business owned by Travis Kalanick, Uber’s co-founder and former CEO.

Competing with Kalanick

Kalanick resigned under pressure in June of 2017 following a series of allegations of sexual harassment. In August, Uber appointed Dara Khosrowshahi, former CEO of Expedia, to take his place. Since then, Khosrowshahi has made it his mission to right the ship in the wake of the scandals, while Kalanick has stayed largely out of the spotlight.

A year after parting ways with Uber, Kalanick purchased a real-estate company called City Storage Systems for $150 million but has instructed employees to keep the company off their LinkedIn profiles in favor of a “more secretive approach.”

But as his startup, CloudKitchens, “expands its main business of renting kitchen space, it’s becoming harder to hide,” Bloomberg notes. CloudKitchens has already been successful in Los Angeles and has plans to operate in San Francisco and Chicago soon.

Kalanick reportedly hired former employees from Uber, which prompted Uber to warn the former executive not to recruit its staff. An Uber spokesperson declined to discuss any plans with Bloomberg regarding a kitchen-rental service. Uber also didn’t acknowledge any conflict with Kalanick.

"The more restaurants there are, the more selection Uber Eats customers can enjoy, and we believe that the growth of CloudKitchens and others like it will be great for both the food industry and for consumers," the spokesperson said.

Slowly, the health care industry is taking steps to lower skyrocketing prescription drug prices.

UnitedHealthcare says it is working with OptumRx to expand its consumer point-of-sale prescription drug discount programs to apply to all new employer-sponsored plans, making medications more affordable and improving health outcomes.

The companies will require that discounts offered to pharmacy benefit managers show up in the price consumers pay for drugs. During the recent debate over drug prices, some pharmaceutical executives have blamed the drug distribution system for high prices.

For new business beginning next year, OptumRx and UnitedHealthcare say they will only support new employer clients that incorporate point-of-sale discounts to consumers as part of their plan design.

9 million more patients

UnitedHealthcare says the move is expected to accelerate adoption of point-of-sale discounts across all types of commercial business, including those that are self-funded. The policy shift expands a current discount program implemented a year ago, providing discounts to 9 million more patients.

“Patients are seeing concrete benefits from UnitedHealthcare’s groundbreaking point-of-sale discount program, which is just one element in our commitment to help deliver better health, lower costs and a better experience,” said Daniel J. Schumacher, president and COO of UnitedHealthcare.

Schumacher said the action UnitedHealthcare and OptumRx are taking will bring “real value” to consumers while lessening the impact of persistent drug price inflation.

Follows Eli Lilly’s move

This is the second action in recent days by the health care industry to reduce the price that all consumers pay for prescription drugs. Earlier this month, Eli Lilly introduced a lower-priced version of its insulin drug, Humalog.

Lilly says the new version will cost 50 percent less than Humalog, which is used in the treatment of diabetes. The company made it clear that it is responding to growing complaints from consumers and policymakers about expensive drugs.

In fact, both price actions come amid growing pressure from Congress to rein in soaring drug prices. Making the pressure more threatening to the health care industry is the fact that both Democrats and Republicans -- including the President -- are calling for action if prices don’t come down.

In late February, the Senate Finance Committee called seven drug company executives to explain why drug prices are so high. The executives complained that they discount their products to pharmacy benefit managers but acknowledged that doesn’t help consumers who lack adequate coverage.

Weight training can be intimidating for many consumers, but a new study conducted by researchers from Iowa State University could encourage some people to hit the gym -- even lightly.

According to the study, building a moderate amount of muscle strength can be effective in reducing the risk of developing type 2 diabetes.

“Naturally, people will want to know how often to lift weights or how much muscle mass they need, but it’s not that simple,” said researcher DC (Duck-chul) Lee. “As researchers, we have several ways to measure muscle strength, such as grip strength or bench press. More work is needed to determine the proper dose of resistance exercise, which may vary for different health outcomes and populations.”

Getting stronger and healthier

To see how strength training affected study participants’ likelihood of developing type 2 diabetes, the researchers had over 4,600 participants engage in muscle-building exercises. None of the participants had type 2 diabetes at the start of the study, and all were evaluated by physicians both at the beginning and end of the experiment.

The participants completed leg and bench press exercises for the duration of the study, which lasted for two and a half decades, and were divided into groups based on gender, age, and overall strength score.

The researchers found that gaining a moderate amount of muscle mass lowered the risk of type 2 diabetes by over 30 percent. In good news for consumers who don’t love to spend tons of time at the gym: neither gaining muscle mass beyond what the researchers deemed “moderate” nor participants’ cardiorespiratory fitness added more protection against the disease.

“You’re not necessarily going to see the results of resistance training on your bathroom scale, but there are several health benefits,” said researcher Angelique Brellenthin. “It may help lower your risk of type 2 diabetes even though you do not lose body weight, and we know maintaining muscle mass helps us stay functional and independent throughout life.”

According to the researcher’s findings, the reduced risk of type 2 diabetes was due to muscle training and was independent of diet, high blood pressure, alcohol or cigarette consumption, or obesity. The team wants to encourage consumers to participate in these low-maintenance workouts, as they aren’t as arduous as many believe.

"We want to encourage small amounts of resistance training and it doesn't need to be complicated," Brellenthin said. "You can get a good resistance workout with squats, planks or lunges. Then, as you build strength, you can consider adding free weights or weight machines."

Fighting type 2 diabetes

Researchers have been looking for ways to help consumers fight type 2 diabetes, and they have come up with several ways to protect against the disease.

Studies have found positive personality traits, eating eggs, and high-intensity interval training were all effective in reducing the risk of type 2 diabetes.

The Consumer Price Index (CPI), the government’s primary inflation gauge, rose 0.2 percent in February after being flat the month before. In the last 12 months, the CPI is up 1.5 percent, well below the Federal Reserve’s inflation target.

The means the Fed is even more likely to hit the pause button on additional interest rate hikes for the rest of 2019. Robert Frick, corporate economist at Navy Federal Credit Union, says the numbers were up but not as much as expected.

“Inflation doesn’t appear to be heating up enough to trigger the Fed to raise interest rates, and it also shows that increases in wages aren’t pushing up prices much,” Frick said in an email to ConsumerAffairs. “No Fed action, tame inflation, and a good wages and jobs situation mean we remain in the Goldilocks zone for American workers and consumers.”

Some rising costs

Despite the low numbers consumers faced higher costs last month for housing, food, and gasoline. Food costs were up 0.4 percent, their largest monthly increase since May 2014, as both the food at home and food away from home indexes increased.

The index tracking the cost of gasoline rose 1.5 percent in February, following three consecutive monthly declines. That pushed the overall cost of energy up 0.4 percent despite declines in the electricity and natural gas indexes.   

While it’s always good for consumers when prices remain stable, the best news in the report is the influence on the Fed’s interest rate policy. The Fed’s discount rate directly correlates to credit card interest rates.

If the Fed holds off on rate hikes for the rest of 2019, it means consumers’ interest rates on their credit card balances won’t be going up.

Smoking is dangerous for all consumers, but perhaps none more than expectant mothers. Now, researchers from Seattle Children’s Hospital are exploring how smoking during pregnancy can lead to fatal consequences.

According to the study, mothers who smoke while pregnant -- even one cigarette per day -- double their risk of their newborn dying from sudden unexpected infant death (SUID).

“With this information, doctors can better counsel pregnant women about their smoking habits, knowing that the number of cigarettes smoked daily during pregnancy significantly impacts the risk for SUID,” said Dr. Tatiana Anderson.

“Similar to public health campaigns that educated parents about the importance of infant sleep position, leading to a 50 percent decrease in sudden infant death syndrome (SIDS) rates, we hope advising women about this risk will result in less babies dying from these tragic causes.”

Smoking risk

To see how smoking while pregnant affected the likelihood of SUID, the researchers examined data from nearly 20 million births between 2007 and 2011 while also taking into consideration mothers’ smoking habits.

The researchers found a direct link between smoking and SUID risk, as those who smoked during pregnancy -- even just one cigarette per day -- doubled their risk of their newborn dying due to SUID.

The study revealed that 19,000 of the 20 million births resulted in SUID-related deaths, and the researchers traced all of those cases back to SIDS. Medical experts are unsure why infants develop SIDS, as the babies are healthy before encountering fatal breathing trouble while sleeping.

The researchers did find ways for women to reduce their risk of SUID. Quitting smoking before pregnancy reduced the risk of SUID by over 20 percent, while scaling down the cigarette habit during pregnancy reduced the risk by over 10 percent.

The researchers posit that SUID deaths would decrease by over 20 percent if all women stopped smoking during pregnancy, preventing approximately 800 infant deaths every year. Moving forward, the team hopes these results inspire lawmakers to get women the support and encouragement they need to quit smoking before becoming pregnant.

“The most important takeaway is for women to understand that quitting smoking before and during pregnancy by far results in the greatest reduction in SUID risk,” Dr. Anderson said. “For pregnant women unable to quit entirely, every cigarette they can eliminate will reduce the odds of their child dying suddenly and unexpectedly from SUID.”

Dangerous effects of nicotine

For children of smokers, the risks don’t end just because they’ve grown past their infant and toddler years. Researchers have found that early exposure to nicotine can affect babies’ brain chemistry.

The study found that babies are at risk in the womb when their mother is either exposed to secondhand smoke or smokes herself; there are several serious health risks, including pregnancy complications, miscarriage, or development of ADHD or other conduct disorders.

Another recent study found that fathers’ smoking habits can affect cognitive abilities in their children and grandchildren.

“Doctors may not warn men that their smoking could be harming their unborn child even if the mother never smoked,” said researcher Pradeep Bhide. “I believe our study brings this to the fore.”

American Honda Motor Co., is recalling 1,108,939 of the following vehicles:

• model year 2003 Acura 3.2CLs,
• model year 2013-2016 ILXs,
• model year 2013-2014 ILX Hybrids,
• model year 2003-2006 MDXs,
• model year 2007-2016 RDXs,
• model year 2002-2003 3.2TLs,
• model year 2004-2006, and 2009-2014 TLs,
• model year 2010-2013 ZDXs,
• model year 2001-2007 and 2009 Honda Accords,
• model year 2001-2005 Civics,
• model year 2003-2005 Civic Hybrids,
• model year 2001-2005 Civic GX NGVs,
• model year 2002-2007 and 2010-2011 CR-Vs,
• model year 2003-2011 Elements,
• model year 2007 Fits,
• model year 2002-2004 Odysseys,
• model year 2003-2008 Pilots, and
• model year2006-2014 Ridgelines.

The vehicles received a replacement driver airbag inflator as part of a previous Takata inflator recall remedy or a replacement driver air bag module containing the same inflator type as a service part.

Due to a manufacturing error, in the event of a crash necessitating deployment of the driver front airbag, these inflators may explode.

An explosion of an inflator within the driver front airbag module may result in sharp metal fragments striking occupants resulting in serious injury or death.

What to do

Honda will notify owners, and dealers will replace the driver's airbag inflator free of charge.

Owners will be notified of the recall beginning on April 17, 2019; however, dealers are ready to begin repairs immediately.

Honda owners may contact customer service at (888) 234-2138. Honda's number for this recall is O41. Acura owners may contact customer service at the same number. Acura's number for this recall is U40.

Washington Beef of Toppenish, Wash., is recalling approximately 30,260 pounds of ground beef chubs.

The products may be contaminated with extraneous materials -- specifically hard plastic and metal.

There are no confirmed reports of adverse reactions due to consumption of these products.

The list of items being recalled, produced on December 27, 2018, with a “Use or Freeze by” date of 01/20/19, can be found here:

The products subject to recall bear establishment number “EST. 235” inside the USDA mark of inspection.

The recalled products were shipped nationwide.

What to do

Customers who purchased the recalled products should not consume them, but discard them or return them to the place of purchase.

Consumers with questions about the recall may contact Jay Theiler at (855) 472-6455.

After nearly a year of testing out its service and emotional support animal program, American Airlines is refashioning its policies and procedures.

“The goal of these changes is to protect customers who have a legitimate need as well as the team members who work every day to keep all customers safe,” the airline said in a news release. The new changes will be effective for travel starting on April 1.

Complaints about service and emotional support animals have doubled in the last three years. The extremes of in-flight situations -- biting, urinating, or defecating -- set off a maelstrom of policy changes as major U.S. airlines wrestled with finding the perfect way to handle the situation. Even airports got on the bandwagon, going to the extent of creating pet-relief stations and roaming space for pets to frolic.

Miniature horses?

American laid out its new credo -- some with direct consumer implications:

1. American supports the rights of customers, from veterans to people with disabilities, with a legitimate need for a trained service or support animal. Unfortunately, untrained animals can lead to safety issues for team members, customers and working service and support animals onboard aircraft.

2. American surveyed 10,400 team members and 18,000 customers about these issues and used their feedback to enact these new policies. The results of this survey, along with additional comments from the airline, were submitted to the U.S. Department of Transportation. The airline’s comments focus on a variety of pet-centric issues ranging from the limitation of species to how it will handle itineraries that include “code-share” partners.

3. Effective for travel on or after April 1, a traditional service animal may be a dog, a cat or, in some limited circumstances, a miniature horse. Emotional support animals are limited to either a dog or cat only; a customer may only bring one emotional support animal onboard aircraft.

4. American will require a Veterinary Health Form, along with immunization details, for emotional support animals. Details regarding all of these updated changes and forms, as well as the advanced notice and pre-clearance policy, are available here.

5. Animals under four months of age will no longer be permitted to travel as service or support animals. Animals under this age usually have not received the necessary vaccinations that protect team members and customers.

What’s next?

It’s too early for consensus on whether American’s new plan will stick or if it’s just another step in toward finding the perfect groove.

If the last year is any indication, other major airlines are likely to follow suit and implement changes from the experiences they’ve encountered with their new policies.

If the question of service or emotional support animals impacts you as a consumer, it’s always smart to get caught up on the current policy of the airline you’re flying with. If you’re flying internationally, policies and the required paperwork can vary greatly from what domestic carriers and the U.S. requires. As an example, foreign airlines are only required to recognize service and support dogs at the present time. One good resource ConsumerAffairs found for international pet travel policies is BringFido.com.

Fliers with pets are always wise to check with the Federal Aviation Administration’s (FAA) to review its latest updates on the matter. You can find the FAA’s current stance on the situation by clicking here. The agency has also produced this video to give consumers a broad overview.

An Ethiopian Airlines jet crashed on takeoff Sunday from Addis Ababa and all 157 people on board were killed.

Air crashes have become a rarity in recent years, but the crash of the Ethiopian Airlines plane follows the October crash of a Lion Air jet that killed 189 passengers and crew. The fact that both planes were Boeing 737 Max 8s may be a coincidence -- after all, the Boeing 737 is the most widely used aircraft type for commercial aviation.

Even so, both recent crashes occurred shortly after the planes took off so investigators may take a closer look at the aircraft and its safety features.

‘Almost unheard of’

In both recent crashes, the jets were fairly new, having been placed into service just months before. John Cox, a senior crash investigator and former airline pilot, told CNBC that “it’s almost unheard of” for two new airliners to have fatal crashes so close together. He points out, however, that there doesn’t appear to be any evidence the two planes suffered the same failure.

Boeing says it has assembled a crew that will travel to Ethiopia to assist in the crash investigation.

“Boeing is deeply saddened to learn of the passing of the passengers and crew on Ethiopian Airlines Flight 302, a 737 MAX 8 airplane,” the company said in a statement. “We extend our heartfelt sympathies to the families and loved ones of the passengers and crew on board and stand ready to support the Ethiopian Airlines team.”

While plane crashes were tragic but regular occurrences in the past, they seem almost shocking now. Commercial aviation safety hit an all-time high in 2017 when the Aviation Safety Network (ASN) reported just 10 fatal commercial aircraft accidents resulting in 79 deaths. None of the accidents occurred in the U.S. or involved U.S. airlines.

At the time, ASN President Harro Ranter told ConsumerAffairs that years of learning from accidents and worldwide knowledge-sharing likely contributed to the improved safety record.

Nearly two decades without a major crash

The U.S. has been at the forefront of improved flight safety. Since November 12, 2001, when American Airlines flight 571 crashed on takeoff in a Queens, N.Y. neighborhood, there has been no major passenger jet crash among U.S.-chartered airlines.

During that time there were fatal crashes involving commuter aircraft in Charlotte, N.C., Lexington, Ky., and Clarence, N.Y. In 2013, an Asiana Airlines jet crash-landed at San Francisco International Airport, killing two passengers.

Last year, a passenger aboard a Southwest Airlines Boeing 737 was killed when an engine exploded and flying metal broke a window. The woman sitting next to the window died after the loss of pressurization nearly pulling her out of the aircraft. An investigation attributed the engine failure to metal fatigue.

Southwest Airlines’ fleet is mostly made up of Boeing 737 aircraft.

In case you had any optism left that vaping could be a healthy alternative to smoking, a new study of nearly 100,000 Americans adds to the growing pile of evidence that e-cigarettes hurt smokers more than they help.

The new research, set to be presented next week at the American College of Cardiology's 68th Annual Scientific Session, is based on data about 96,467 people that was collected by the National Health Interview Survey, a federal government program that falls under the Centers for Disease Control and Prevention (CDC).

According to the findings, Americans who reported smoking e-cigarettes in the survey were 56 percent more likely to have a heart attack, 30 percent more likely to suffer a stroke, 10 percent more likely to suffer from coronary artery disease, and twice as likely to report depression or anxiety.

"These data are a real wake-up call and should prompt more action and awareness about the dangers of e-cigarettes," author Dr. Mohinder Vindhyal, a professor at the University of Kansas School of Medicine Wichita, told Environmental Health News in a statement.

“When the risk of heart attack increases by as much as 55 percent among e-cigarettes users compared to nonsmokers, I wouldn't want any of my patients nor my family members to vape," he added.

Mounting evidence

Experts say that the synthetic chemicals that create the seemingly harmless “puff” of fake smoke are the likely culprit.

The study follows three others published in recent years suggesting a link between e-cigs and cardiovascular problems and strokes. This particular report is significant because it also detected a link between e-cigs and circulatory problems, according to Dr. Stanton Glantz, a University of California, San Francisco researcher who has studied the dangers of smoking regular old cigarettes for decades, as well as e-cigarettes more recently.

On his website, Glantz writes that e-cigarettes are also harmful because they don’t actually encourage people to quit their cigarette addictions.

“Of course, most smokers who use e-cigs continue to be dual users, he writes, (i.e., continue using both products at the same time),” he writes, “which is substantially more dangerous than using either product alone.”

The U.S. Attorney for the Southern District of New York has charged Konstantin Ignatov and his older sister Ruja Ignatova with running “a multibillion-dollar pyramid scheme” through OneCoin, a cryptocurrency they helped found in 2014.

Ignatov has been arrested, but his sister remains at large. The pair is accused of orchestrating a multi-level marketing network that persuaded consumers to buy OneCoin packages that had no real value.

Bulgaria-based OneCoin allegedly rigged prices, sold nonexistent coins, and didn’t even have a true, verifiable blockchain to manage the virtual currency.  

"As alleged, these defendants created a multibillion-dollar 'cryptocurrency' company based completely on lies and deceit," Manhattan U.S. Attorney Geoffrey S. Berman said in a statement. "They promised big returns and minimal risk, but, as alleged, this business was a pyramid scheme based on smoke and mirrors more than zeroes and ones. Investors were victimized while the defendants got rich."

Defrauding investors

Investigators say OneCoin, which is still running, was created with the sole purpose of defrauding investors. Between 2014 and 2016, OneCoin made about €2.2 billion ($2.5 billion) in profit, according to the US Justice Department.

“This is an old scam with a virtual twist,” IRS Special Agent in Charge John R. Tafur said in a statement. “IGNATOV and IGNATOVA allegedly convinced victims to invest in OneCoin based on complete lies about the virtual currency.”

“IRS Criminal Investigation is committed to investigating cryptocurrency scams in an effort to protect the American public and bring cryptocurrency crooks to justice,” Tafur said.

The uncovering of the alleged scheme serves as a reminder to consumers that multi-level marketing and tiered referral systems are red flags, especially during a time when officials are still trying to figure out how to regulate virtual currencies.