Vitamin D Deficiency: A Major Epidemic In the US

Theories connecting vitamin D deficiency to a number of cancers have not only been tested, but established as correct, in over 250 epidemiological studies. A grasping of its foundation from a physiological standpoint has stemmed from over two thousand lab studies, as stated by doctor Ced Garland, who is also a professor at the medicinal department of UCSD. Presented below are a few of the salient points that establish the need for greater vitamin D intake:

  • Some 610,000 instances of breast & colon cancers could have been stopped every year had vitamin D levels been upped world-wide. This is only taking account of the number of deaths for 2 kinds of cancer!
  • When you optimize vitamin D levels, that can actually help you to stop at least a whopping sixteen different kinds of cancer, some of which include: cancer of the pancrease, the lungs, the ovaries, the prostate, and skin cancers.
  • A massive study on vitamin D & cancer indicated that vitamin D can slash one’s risk of getting cancer by up to 60%! When this came out, it became such groundbreaking news that the Canadian Cancer Society had actually told everyone that taking more vitamin D was the cure for cancer.
  • According to the Mercola archives, Doctor Bill Grant’s study showed that close to 30% of cancer-related deaths – which amounts to 2,000,000 all over the world and 235,000 in America – could be stopped every single year with greater vitamin D intake.
  • According to the Mercola archives, Vitamin D protects against cancer in a great many ways:

    • It can cause cells with some sort of a mutation to self-destruct
    • Reduce the spread & reproduction of cancer cells
    • Cause cells the unhealthy cells to actually begin to appear different from the healthy noes (a great many cancer cells are hard to spot out, because they don’t look abnormal)
    • Reduce the growth of newer blood vessels from ones that already exist – a step in the transition of dormant tumors that turn malignant

Getting past cancer, researchers have pointed out that increasing levels of vitamin D3 could prevent other chronic diseases that claim nearly one million lives throughout the world each year! Vitamin D also fights colds and the flu, as it modulates and improves the expression of genes that foment your immune system to defeat deadly pathogens. In fact, it is very rare for someone with optimized vitamin D levels to come down with the flu.

A Great Many Are Vitamin D Deficient

In winter time in the US, the typical vitamin D levels is only at about 15-18 ng/ml, an extremely serious deficiency state. Additionally, it is thought more than a whopping 95 percent of senior citizens in America may be vitamin D deficient. That’s not the only whopping statistic: 85 percent of the American public is considered vitamin D deficient as well! Further, the Mercola archives claim that:

  • Being deficient in vitamn D is a major problem in adults, young or old, with darker skin, like folks whose progenitors are Africans, the Middle Easterners, or Indians, who constantly wear sunscreen, or who don’t partake in very many outdoor activities.
  • Black people and other people with darker skin, and also the folks residing in northern latitudes make much less vitamin D than other groups.
  • Sixty-five percent of people with type-2 diabetes have vitamin D deficiency.
  • Studies made clear that very low levels of vitamin D has become an epidemic among young kids, the old, and vast majority of the female population.
  • A study done in America revealed that almost one in two black women of fourteen and up may have a vitamin D deficiency.

Consumer Awareness for Health Care

For the most part, Americans are champ consumers. But we’re not such good shoppers when it comes to our own health. Studies show that Americans spend more time researching car purchases and new appliances than they do choosing doctors and health plans.

We’re not even sure we have options. Over half of all Americans said in a recent survey they did not feel confident that they could reduce the cost of health care by shopping around. And many of us are shy about negotiating with our doctors, or asking if an expensive test is really necessary.

Meanwhile, escalating health care costs have burdened both employees and employers. The average cost of a visit to the doctor is about $199; a visit to the ER costs about $922, according to AHRQ. About 25% of those visits are unnecessary. You can imagine how many billions of dollars this costs everyone every year.

You can start researching NOW to get coverage before the OPEN ENROLLMENT IS UP!!! 

APPLICATION DEADLINE FOR COVERAGE STARTING APRIL 1st, 2014 IS MARCH 15!

health-insurance-marketplace-highlight  

OPEN ENROLLMENT ENDS MARCH 31ST

Diet Pill Supplement OxyElite Linked to Liver Failure

OxyElite Pro

Health officials are asking stores to pull a fat-burning supplement from shelves after officials linked it to cases of liver failure and acute hepatitis in 29 people.

Two people have undergone liver transplants and one person has died, according to the Hawaii State Department of Health. Twenty-four of the people who fell ill reported using OxyElite Pro before being diagnosed; the patients had no other medication or supplement in common.

While the investigation is ongoing, health officials advised people to “discontinue use of the product at this time.” Hawaii investigators are working with the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.

“Anyone who develops symptoms such as abdominal pain or discomfort, fatigue, loss of appetite, nausea and/or vomiting, and yellow skin or eyes should consult their doctor immediately,” Health Director Loretta Fuddy said in a statement.

OxyElite Pro is sold nationwide. Because it is a dietary supplement, it did not have to be approved by the FDA before going to market.

USPlabs, the company that produces OxyElite Pro, said it stands by the safety of all its products, but “out of an abundance of caution,” the company is stopping domestic distribution of OxyElite Pro with the purple top and OxyElite Pro Super Thermo Powder.

“The company continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii,” USPlabs said in a statement.

USPlabs informed the FDA that counterfeit versions of OxyElite Pro have been circulating in the United States, according to an advisory issued by the FDA. The agency is investigating whether counterfeit products are linked to any of the hepatitis cases.

USPlabs once also produced a product called OxyElite Pro with DMAA, but that has not been manufactured or distributed since earlier this year, the company said.

In April, the FDA said it was using “all available tools at its disposal” to eliminate supplements containing the stimulant dimethylamylamine, or DMAA, from the market. The agency said DMAA can cause increased blood pressure, shortness of breath, chest tightening, cardiovascular problems and even heart attacks.

FDA spokeswoman Tamara Ward told CNN at the time that 11 companies had received warning letters from the FDA over the past year asking them to stop marketing products that contain DMAA. All but one — USPlabs — agreed to stop using DMAA in supplements.

– CNN Health update

CDC Sounds Alarm on Antibiotic-Resistant Bacteria

Report cites overuse of antibiotics as key to the life-threatening problem.

info by Dennis Thompson, HealthDay News
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MONDAY, Sept. 16 (HealthDay News)  More than 2 million people come down with infections from antibiotic-resistant bacteria every year in the United States, leading to at least 23,000 deaths, according to a report released Monday by federal health officials.

The report marks the first time that the U.S. Centers for Disease Control and Prevention has performed a comprehensive analysis of the impact on society from antibiotic-resistant bacteria, said Dr. Steve Solomon, director of the agency’s Office of Antimicrobial Resistance.

“This is scary stuff, and we want people to know about it,” he said.

The report outlines how antibiotic resistance occurs in patients and spreads through the community. It also lists medical procedures that have become more dangerous because of these bacteria. Those procedures include dialysis, chemotherapy, complex surgery and organ transplants.

Antibiotic overuse is the single most important factor leading to antibiotic resistance, according to the report. Antibiotics are among the most commonly prescribed drugs, but as many as half of those prescriptions are either not needed or not the best course of treatment for the patient, the report said.

“Patients need to understand that antibiotics are not the solution for every illness,” Solomon said. “It’s important that people not take antibiotics when they aren’t necessary. It contributes to resistance, and it also has consequences to the patient in the form of side effects.”

The CDC also faulted the use of antibiotics in food animals to prevent, control and treat disease, and to promote their growth. “The use of antibiotics for promoting growth is not necessary, and the practice should be phased out,” the report stated.

The centerpiece of the CDC report is a threat-level assessment for 18 bacteria- and antibiotic-related illnesses, broken down into three categories: urgent, serious and concerning.

Three antibiotic-related illnesses are ranked as urgent threats demanding immediate attention:

  • Carbapenem-resistant Enterobacteriaceae , or CRE, are a family of bacteria that have developed remarkable drug resistance in recent years. Half the people who get bloodstream infections from CRE die. About 9,300 hospital infections of CRE occur each year. “A lot of those bacteria are becoming resistant to every antibiotic we have,” Solomon said of CRE. “We are very concerned about significant spread over the next few years.”
  • Neisseria gonorrhoeae — the bacteria that causes gonorrhea — are showing signs of resistance to the cephalosporin family of antibiotics. The CDC estimated that about one-third of the 820,000 annual gonorrhea infections involve strains that have become antibiotic-resistant. “The cephalosporins are really the last line of defense we have against gonorrhea,” Solomon said. “It has shown its ability to become resistant to every antibiotic we throw at it. If we lost those — if this cephalosporin-resistant gonorrhea spreads — that disease is going to be untreatable.”
  • Clostridium difficile is bacteria that, although not antibiotic resistant, poses an urgent threat because it causes diarrhea linked to at least 250,000 hospitalizations and 14,000 American deaths each year. C. difficile infections occur because of antibiotic use that destroys the good bacteria in people’s bodies that protect against illness. “Because there has not been as much success in addressing the problem of antibiotic overuse, we are flagging that as an urgent problem because it has to be brought under control,” Solomon said.

Twelve infections from antibiotic-resistant bacteria are listed as serious, and three as concerning. For each bacteria threat, the CDC offers guidance for what healthcare industry officials, medical professionals and the general public can do to limit its spread.

Infections by antibiotic-resistant bacteria add as much as $20 billion in excess direct health-care costs, with additional costs for lost productivity as high as $35 billion a year, according to the report.

In its report, the CDC outlined a four-pronged strategy for combating antibiotic-resistant bacteria:

  • Preventing infections and preventing the spread of resistance.
  • Tracking resistant bacteria.
  • Improving the use of existing antibiotics.
  • Promoting the development of new antibiotics and new diagnostic tests for resistant bacteria.

“As different as these problems are, the same strategies to address them are shared in common,” Solomon said. “By helping people understand that those four core strategies are shared among the ways we address all of these antibiotic-resistant bacteria, we put it all in context and provide a glimpse of the big picture.”

Dr. Georges Benjamin, executive director of the American Public Health Association, said he appreciates the report’s frank, down-to-earth manner.

“[The report] gives us a handle. Something we can use to talk with the public,” he said. “Obviously, there is an enormous risk to the health of the public by antibiotic resistance, and it’s going to take a multiple-sector response to resolving it.”

Woman Disfigured by Generic Drug Loses $21 Million Award

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Eight years after she was burned and blinded by a prescription drug, Karen Bartlett feels numb.

This week the Supreme Court ruled that Mutual Pharmaceutical Co., the maker of the drug Bartlett took for shoulder pain, should not be held responsible for her injuries because the company had copied the brand drug’s formula and warning label.

“I was numb,” Bartlett said of the moment her lawyer delivered the news. “I don’t even have words to describe it because I can’t believe that they would do that.”

In a five-four decision, the court ruled Monday that generic drug makers could not be sued by patients over defective drug design because they’re required by federal law to copy their brand-name counterparts. The ruling overturns the verdict from Bartlett’s 2010 New Hampshire Superior Court trial in which a jury awarded her $21 million in damages, as well as the decision by an appeals court to uphold the verdict.

“I can’t believe the Supreme Court can just say, ‘I’m sorry, you guys are wrong,'” said Bartlett, whose body is scarred from the fierce reaction to sulindac, a generic version of the nonsteroidal anti-inflammatory drug Clinoril. “It boggles my mind. I just don’t get it.”

Bartlett remembers little from the three months she spent at Massachusetts General Hospital in 2004, “wrapped up like a mummy” as the skin eroded two-thirds of her body. She was diagnosed with Stevens-Johnson syndrome, a rare and sometimes fatal reaction triggered by certain medications, including NSAIDS like Clinoril and sulindac.

The ordeal left her disfigured and legally blind. She also has lung damage and difficulty swallowing.

“I have no independence,” said Bartlett, 53, who lives off disability checks for a fraction of the salary she once earned as a secretary at an insurance company in Plaistow, N.H. “This ruined my life, basically.”‘

Motrin Lawsuit: Jury Awards Girl $10 Million for Burns and Blindness

In a lawsuit against Mutual Pharmaceutical Co., Bartlett’s lawyer argued that the company “failed to adequately warn users” about Stevens-Johnson syndrome, one of sulindac’s more serious, albeit very rare side effects. A jury in New Hampshire Superior Court agreed, awarding Bartlett the $21 million payout to cover medical and legal costs, and compensate her for “physical and mental pain and suffering” as well as “loss of enjoyment of life,” according to the complaint.

At the time of Bartlett’s reaction, sulindac’s label did not specifically warn about Stevens-Johnson Syndrome, the Supreme Court acknowledged, though it did warn that the drug could cause “severe skin reactions” and “fatalities.” But under federal law, generic drugs must be chemically identical to the FDA-approved brand-name drug and don the same warning label.

“Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac’s label or composition and its state-law duty to either strengthen the warnings on sulindac’s label or change sulindac’s design,” Supreme Court Justice Samuel Anthony Alito Jr. wrote in the majority opinion of the court.

In 2005, one year after Bartlett’s reaction, the Food and Drug Administration recommended changes to the labeling of all NSAIDs, including Clinoril and sulindac, to more explicitly warn about Stevens-Johnson syndrome.

Alito noted that Bartlett’s case “arises out of tragic circumstances” and “evokes deep sympathy.

“But sympathy for [Bartlett] does not relieve us of the responsibility of following the law,” he wrote.

Jay P. Lefkowitz, the lawyer who represented Mutual Pharmaceutical Co., said the ruling “vindicates the authority” of the FDA, the federal agency charged with assessing drug safety.

“The FDA has the scientific and medical expertise to make decisions about the safety and efficacy of drugs based on all of the data,” said Lefkowitz, whose office is based in New York City. “State court juries that are only looking at one example of a tragic side effect don’t have the ability to make an assessment about the safety and efficacy of a drug that millions of people use with good results.”

Lefkowitz said his “heart was filled with sympathy” for Bartlett.

“Every one of us takes prescription drugs. We give them to our kids, and this can happen to anyone,” he said. “But I think the court got it right, even though it’s obviously a tragic set of circumstances.”

Supreme Court Justice NSAIDS disagreed with the court’s decision, writing in her dissent that it “leaves consumers like Karen Bartlett to bear enormous losses on their own.”

Bartlett said, “I walk away with nothing except disability checks. They don’t seem to care that this has affected me for rest of life.”

 

ABC News Story: health

By 

FDA Changes for Sunscreen Labels

 

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The United States Food and Drug Administration has announced significant changes to sunscreen product labels that will help consumers decide how to buy and use sunscreen, and allow them to protect themselves and their families from sun-induced damage more effectively.

How sunscreen works. Most sun protection products work by absorbing, reflecting, or scattering sunlight. They contain chemicals that interact with the skin to protect it from UV rays. All products do not have the same ingredients; if your skin reacts badly to one product, try another one or call a doctor.

 

SPF. Sunscreens are assigned a sun protection factor (SPF) number that rates their effectiveness in blocking UV rays. Higher numbers indicate more protection. You should use a sunscreen with at least SPF 15.

 

Reapplication. Sunscreen wears off. Put it on again if you stay out in the sun for more than two hours, and after you swim or do things that make you sweat.

 

Expiration date. Check the sunscreen’s expiration date. Sunscreen without an expiration date has a shelf life of no more than three years, but its shelf life is shorter if it has been exposed to high temperatures.

 

Cosmetics. Some make-up and lip balms contain some of the same chemicals used in sunscreens. If they do not have at least SPF 15, don’t use them by themselves.

 

Avoid Indoor Tanning

Using a tanning bed, booth, or sunlamp to get tan is called “indoor tanning.” Indoor tanning has been linked with skin cancers including melanoma (the deadliest type of skin cancer), squamous cell carcinoma, and cancers of the eye (ocular melanoma).

 

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Source: CDC & FDA

‘Low-T’ Ads Cause Major Jump in Prescriptions

 

Researchers sounded  an alarm today on ads touting the wonders of testosterone treatments.

Testosterone is billed by some as a virtual fountain of youth — a miracle drug for middle-aged men looking for a boost from the boardroom to the bedroom.

CEO Chris Running, 57, told ABC News “low-T” was a wonder drug that had helped him lose weight, gain muscle and generally feel young again.

“When I get out of the shower, and look in the mirror, I’m impressed,” Running said. “I really mean that. I mean like looking at myself in the mirror, I look freaking awesome!”

 

gty low t drug nt 130603 wblog Low T Testosterone Ads Leading to Increase in Prescriptions, Experts Warn

Researchers in Texas, however, said that all those ads may be driving a potentially worrisome amount of overtreatment.

Between 2001 and 2011, they said testosterone prescriptions tripled among men older than 40.

But they said  a full quarter of those men had been put on testosterone without even having had their levels checked first to see whether they needed it.

“It’s become a near-epidemic proportions, what we’re seeing in our clinics,” said Dr. Edmund Sabanegh, the chairman of urology at the Cleveland Clinic.

The New England Journal of Medicine warned that only about 2 percent of men older than 40 should be getting a boost at all.

That’s because while added testosterone can lead to increased muscle mass and sex drive, some doctors said too much raises the risk of prostate cancer and liver damage.

In an interview with ABC News, Greg Miley of AbbVie, the makers of AndroGel, a popular low-T treatment, said: “The prescribing of topical testosterone replacement therapies can only be prescribed by a physician after taking the patient’s complete medical condition into consideration.”

Eli Lilly, the makers of another low-T treatment called Axiron, told ABC News:  ”We encourage patients to talk to their physicians to weigh the benefits and risks before taking any prescription. … Axiron is a prescription medication, approved by the FDA, for men with certain conditions associated with a deficiency or absence of testosterone. Lilly does not condone the use of our medicines for off-label purposes. ”

The red flags raised by researchers, however, don’t seem to be having any effect on the business of low-T.

Walk-in clinics have sprung up across the country. And according to Bloomberg, sales are expected to triple from $1.6 billion in 2011 to $5 billion by 2017.

Jun 3, 2013
Read story here: http://abcnews.go.com/blogs/health/2013/06/03/low-t-testosterone-ads-leading-to-increase-in-prescriptions-experts-warn/

Compounding Pharmacists Await Changes After Fungal Meningitis Scandal

The International Academy of Compounding Pharmacists, or the IACP, includes more than 2,700 pharmacists, most of them in the United States, and Miller said many shouldn’t need to adhere to the same standards as drug manufactures because they are so small. The compounding pharmacists have answered primarily to state pharmacy boards — rather than the U.S. Food and Drug Administration — for decades. As such, FDA inspections have been met with unease and confusion.

“One thing we know is that FDA’s inspectors are not often familiar with pharmacy law,” Miller said. “The pharmacy could be legally compliant, following all the laws of the state. They’re not NECC in any way, and they could actually be found out of compliance by the FDA because agencies inspect using manufacturing standards.”

FDA spokeswoman Sarah Clark-Lynn said the FDA has been coordinating with state officials to conduct 30 risk-based inspections at compounding pharmacies known to mix large quantities of sterile drugs. It is also conducting inspections following complaints about “serious adverse events,” or when states have requested assistance.

So far, 14 inspections have yielded deficiency findings, which the FDA has published online. Although inspectors haven’t found “greenish black foreign matter,” as they found at NECC, the New England Compounding Pharmacy, in October, they posted findings, including how pharmacies had been deficient in practices to maintain sterility, which included keeping skin covered and maintaining proper air flow.

RELATED: NECC Blames Cleaners

“The FDA’s authority over compounding companies is limited but not nonexistent,” Clark-Lynn said. “While the current FDA oversight over compounding pharmacies is limited, the agency continues to use its existing authorities to protect consumers.”

But how limited is it?

Bernardi, who has not been visited by the FDA, said he wondered whether compounding pharmacists could refuse an FDA inspection if a state inspector wasn’t present.

The International Academy of Compounding Pharmacists, or the IACP, includes more than 2,700 pharmacists, most of them in the United States, and Miller said many shouldn’t need to adhere to the same standards as drug manufactures because they are so small. The compounding pharmacists have answered primarily to state pharmacy boards — rather than the U.S. Food and Drug Administration — for decades. As such, FDA inspections have been met with unease and confusion.

“One thing we know is that FDA’s inspectors are not often familiar with pharmacy law,” Miller said. “The pharmacy could be legally compliant, following all the laws of the state. They’re not NECC in any way, and they could actually be found out of compliance by the FDA because agencies inspect using manufacturing standards.”

FDA spokeswoman Sarah Clark-Lynn said the FDA has been coordinating with state officials to conduct 30 risk-based inspections at compounding pharmacies known to mix large quantities of sterile drugs. It is also conducting inspections following complaints about “serious adverse events,” or when states have requested assistance.

So far, 14 inspections have yielded deficiency findings, which the FDA has published online. Although inspectors haven’t found “greenish black foreign matter,” as they found at NECC, the New England Compounding Pharmacy, in October, they posted findings, including how pharmacies had been deficient in practices to maintain sterility, which included keeping skin covered and maintaining proper air flow.

RELATED: NECC Blames Cleaners

“The FDA’s authority over compounding companies is limited but not nonexistent,” Clark-Lynn said. “While the current FDA oversight over compounding pharmacies is limited, the agency continues to use its existing authorities to protect consumers.”

But how limited is it?

Bernardi, who has not been visited by the FDA, said he wondered whether compounding pharmacists could refuse an FDA inspection if a state inspector wasn’t present.

Although FDA officials normally work with state pharmacy boards, FDApolicy states that it should “seriously consider” independent “enforcement action” against compounding pharmacists in certain scenarios, such as when they are compounding large amounts of drugs without a prescription, compounding drugs for third parties for resale or compounding drugs that are copies of existing FDA-approved drugs typically made by drug manufacturers.

However, a 2011 federal court ruling in Texas “prohibited” the FDA from inspecting compounding pharmacies beyond the U.S. Food, Drug, and Cosmetic Act, which specifies that FDA inspectors cannot demand research, financial or sales data from pharmacists who are in compliance with state law unless those pharmacists are manufacturing a new drug.

The 2011 ruling trumped a 2008 ruling that determined the FDA actually did have additional authority over compounding pharmacists because all compounded drugs are new drugs. As such, the 2011 ruling was considered a win for compounding companies and a loss for the FDA.

And those are just the two most recent battles regarding how much authority the FDA has over compounding pharmacists. There are several others.

Chuck Leiter, the third generation president of Leiter’s Compounding Pharmacy in San Jose, Calif., said more FDA regulation would be a good thing, and he’d like to see one clear law across the board.

“I think you need one law across the country,” Leiter said. “While people are arguing jurisdictions, people are dying.”

Clark-Lynn said Congress would have to pass new legislation to expand the FDA’s power and allow it to oversee compounding pharmacists more efficiently.

“There should be appropriate federal standards for these products that are consistently enforced across all 50 states,” Clark-Lynn said. “Until such legislation is enacted, the agency will continue to apply its existing legal authority to protect public health.”

Since the revelations of NECC’s business practices surfaced and continue to be exposed, notably in the March 10 episode of “60 Minutes,” Leiter said compounding pharmacies and clients who were acting wrongly began to right themselves, but the industry still wasn’t guilt-free.

RELATED: Compounding Pharmacists Defend Their Trade After Meningitis Outbreak

Leiter said that despite continued pressure from clinics or doctors’ offices, he still refused to fill prescriptions for patients with fake names. He said, in his experience, fake names had become an industry practice as large-scale compounding pharmacies, such NECC, began acting more like drug manufacturers.

“It’s changing, but some people are still trying to mess with the system,” Leiter said.

Though Bernardi said he had not received requests for prescriptions for patients with fake names, he said he began receiving calls for bulk compounded drug orders once NECC and its sister company, Ameridose, closed. In Massachusetts, compounding drugs for “office use,” meaning they aren’t made specifically for one patient with a prescription, is not allowed.

“The answer is, ‘We need a prescription for a patient,'” Bernardi said.”That’s usually where the conversation ends.”

Both Leiter’s and Bernardi’s pharmacies are accredited by the Pharmacy Compounding Accreditation Board, or PCAB, which is considered the gold standard of compounding pharmacy safety and efficiency.

“I like to sleep at night,” Leiter said. He intends for his daughter to follow in his footsteps and take over the family business, but she has to pass freshman chemistry first.

Since last fall, PCAB has received an increase of “300 or 400 times” its usual number of applicants, said Joe Cabaleiro, the board’s executive director, and he takes that as an encouraging sign.

“I see a lot of our colleagues have also taken a second really hard look at their operations,” Cabaleiro said, “and asked ‘how can we improve as far as what we learned here.'”

Source: ABC News by Sydney Lumpkin

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