If you didn't catch this last night, check out my blog post on the big#NoWaySubway scandal and the commonly used bread-making chemical azodicarbonamide. You'll learn all sorts of amazing stuff you didn't know (and some you didn't want to know) about bread! And please share with your friends! #Subway http://wp.me/p2yVpy-W6
Showing posts with label Research. Show all posts
Showing posts with label Research. Show all posts
Rewind the Future -- Stop the Cycle
We want to thank Strong4Life.com for enlightening us about the growing obesity in the United States and the world.
The video touches on the point that obesity doesn't happen overnight. It's a lifetime worth of bad habits, bad choices, and bad nutrition.
This video is not to promote any one product, but to promote free thought about getting healthy! There's still time to change all that by making better choices!
“Drug Shortages: The Scary Reality of a World Without Meds,” Reader’s Digest Link to original article
Link to original article
Jennifer LaCognata, 40, a booking agent for United Airlines from Safety Harbor, Florida, first suffered an attack of night blindness in early 2011. It took months to properly diagnose her. She was vitamin A deficient, due to a shortened bowel that made her body unable to absorb fat. The good news: The problem was totally fixable with injections of a basic medicine called Aquasol A, made by Hospira, an American generic drug company.
Dan Winters for Reader’s Digest
But bad news quickly followed. LaCognata learned that manufacturing challenges had forced Hospira to stop selling the drug, effectively plunging the entire world into a shortage. Without Aquasol A, LaCognata is going blind. United Airlines placed her on unpaid medical leave because she could no longer look at a computer screen. She is forced to wear an eye patch and can see only kaleidoscopic fragments out of one eye. “My kids call me Pirate now,” she says, “instead of Mom.”
LaCognata and her husband canvassed the world for Aquasol A. They contacted the Food and Drug Administration (FDA), the State Department, and every major eye hospital in America. (They found two vials, but they were expired, so hospitals wouldn’t release them.) The couple wrote and called hospitals and organizations in Israel, China, Canada, and Brazil. LaCognata contacted charities, including the Red Cross and the Helen Keller Foundation, that serve foreign populations prone to vitamin A deficiency, without luck.
A Hospira spokesperson said that the company recognized the “critical need” for Aquasol A and had contracted with a separate manufacturing company to “accelerate the product’s return to market.” But years later, the company has yet to resume its production.
It is listed on Hospira’s website as “out of stock.”
“I can’t believe this could happen in America,” LaCognata says.
Dan Winters for Reader’s Digest
A Shocking Epidemic
It seems unfathomable in our high-tech medical system, but in 2007, 154 drugs were in shortage, a number that almost tripled to 456 in 2012, according to the U.S. Government Accountability Office.
Threatening medical-care options and patients’ lives, drug shortages have occurred in almost every pharmaceutical category. Antibiotics, cancer drugs, anesthesia, pain control, reproductive and gynecological drugs, cardiac medicine, psychiatric drugs, and intravenous-feeding solutions have all been in varying degrees of short supply or not available at all. Recently, nitroglycerin, an emergency room staple used to treat heart attack patients, has been in such severe scarcity that its sole U.S. manufacturer has restricted hospitals to 40 percent of their usual orders. A study published this March in the Mayo Clinic Proceedings attributed more than 15 documented deaths since 2010 to either lack of treatment or the switch to an inferior drug as a result of medication shortages.
Though the FDA has scrambled to alleviate the crisis and physicians have become deft at juggling or substituting treatments, there is no comprehensive solution to this drug-supply breakdown, which has persisted for a complex array of reasons.
The first is all about money. As generic drug prices have dropped, so have manufacturers’ profits. As a result, some manufacturers have failed to invest in infrastructure and quality control. To ensure safety, the FDA has taken regulatory actions that have halted supplies, with sterile injectable drugs, such as pain meds and chemotherapy, dominating the shortage list. (These are the most complex and costly generics to make.) The business model of just-in-time manufacturing—in which companies make drugs as patients need them but do not stockpile extra—leaves no margin for unexpected events.
Noting that there are no shortages of big profit-generators, like Viagra, many practitioners and patients suspect less-than-honorable motives by drugmakers. Some experts suggest that manufacturers may have financial incentive to temporarily stop production of a drug. Medicare reform imposed certain price controls on generic drugs, but, due to a loophole, these controls are lifted if a manufacturer stops making the drug for six months.
Limited manufacturing capacity is an important factor too. Over half the drugs on the FDA shortage list had only one or two manufacturers, according to a report by the IMS Institute for Healthcare Informatics. Some blame hospital buying groups, middlemen that purchase drugs and supplies for many of the nation’s hospitals, which have awarded contracts to some manufacturers and not others, thereby suppressing competition and innovation. The result is that for any given drug, there may be only one or two generic manufacturers left to produce it, which can lead to shortages.
Predatory middlemen are making the situation even worse. A congressional investigation led by Rep. Elijah Cummings, a Baltimore Democrat, has found that shady secondary wholesalers buy up drugs in shortage and resell them, often at exorbitant prices. This explains, in part, the haphazard ebb and flow of the shortages that makes them particularly hard to handle: One day the medicine is just gone, but there’s plenty the next.
But as experts debate the cause of the shortages, there is no disagreement over their devastating impact. They’ve turned pharmacists into professional beggars and have forced doctors to change treatment protocols on the fly—in some cases, turning routine care into a roll of the dice. They’ve stopped clinical trials and have led to the suspension of the death penalty in some states that use lethal injection.
Shortages are leading hospitals and patients to get drugs from less regulated and potentially less safe sources, such as drug compounders, specialty pharmacies that mix medications for individual patients. Some compounding pharmacies, which are not subject to regulation as stringent as that for drug manufacturers, have taken advantage of this and started churning out large volumes of drugs. But this can lead to safety issues. Such dangers became vividly clear in 2012, after contaminated steroids from the New England Compounding Center led to an outbreak of meningitis that killed 64 patients. A 2013 report by the Health and Human Services inspector general found that drug shortages have led 68 percent of U.S. hospitals to turn to compounders to make versions of medicine in short supply.
Patients today have to cope not only with being sick or choosing between treatment options but also with the possibility that the drug they need may be available solely from a risky source—or not at all.
A Scary Reality for Cancer Patients
Those with life-threatening diseases have been hit hardest by shortages, in part because many of their medications have no substitute and their exacting treatment regimens cannot be delayed.
Justine Zirbes, 33, a TV producer in Minneapolis, was seven months pregnant with twins in October 2010 when she learned that her three-year-old, Axel, had leukemia. The distressing news sent her into early labor, and she was confined to bed.
As her son embarked on grueling chemotherapy for a disease that can often be cured if treated—but is almost certainly fatal if not—Zirbes learned that a national shortage of the chemotherapy drug cytarabine would affect his regimen. Doctors offered a drug called clofarabine, which was not standard treatment. Though still pregnant and on bed rest, Zirbes flatly refused. “How is this possible, in this country in 2011, that these lifesaving drugs are not widely available?” Zirbes recalls. “I was beside myself with disbelief.”
Zirbes was justified in her concern. According to a 2012 study in the New England Journal of Medicine, drug substitutions due to shortages led to higher relapse rates among children with an otherwise curable form of lymphoma.
Like Jennifer LaCognata, Zirbes embarked on a quest to find the right medicine. She contacted her senator Amy Klobuchar (D-MN), who took up the cause with proposed legislation. Zirbes produced two news segments on children affected by drug shortages. She worked every connection she had and looked as far away as Europe to find her son’s drug. Ultimately, the day before Axel was due for treatment, the hospital got enough cytarabine to treat him and another child.
Axel was reasonably lucky. Other patients, like Carey Fitzmaurice of Bethesda, Maryland, almost certainly suffered recurrence of their cancer because of drug shortages.
In 2006, Fitzmaurice, 37, was happily married with two young children and a job she loved as a policy analyst at the Environmental Protection Agency, when she learned that she had ovarian cancer and a BRCA1 genetic mutation that had likely caused it.
Over five years, she bravely underwent debilitating treatment, a recurrence of her ovarian cancer, an additional diagnosis of breast cancer, and a radical mastectomy. In the middle of 2011, things finally seemed to be breaking her way. Her breast cancer was in remission, and a chemotherapy drug called Doxil, made by a contractor for the Johnson & Johnson subsidiary Janssen, Inc., appeared to be vanquishing a recurrence of the ovarian cancer. But in August 2011, she learned there was not enough Doxil to complete her treatment.
Fitzmaurice assumed that she would be able to find some on her own. “I work for the federal government,” she says. “A lot of what I do is help people cut through red tape and find solutions. That’s how I tackled cancer to begin with: find out who the right doctor is, where to get surgery.”
But the shortage of Doxil thwarted her every effort. After four months without the medication, her ovarian cancer returned.
In a recent study from the University of Pennsylvania presented at the 2013 annual meeting of the American Society of Clinical Oncology, 83 percent of oncologists and hematologists said they’ve faced cancer drug shortages, and of those, nearly all said their patients’ treatment had been affected by drug shortages.
At the Ohio State University Comprehensive Cancer Center in Columbus, Ohio, Ryan Forrey, associate director for pharmacy and infusion services, says that in 2012, of the 60,000 doses of chemotherapy administered intravenously at his facility, almost 35 percent were affected by shortages. Treatment was interrupted or canceled, patients were switched to alternative drugs, or an alternative supply for the needed drug had to be found. His overwhelmed staff “was forced to beg, borrow, plead to get drugs for patients,” he says.
Now, whenever a patient begins chemotherapy, Forrey’s hospital sequesters the entire treatment regimen, which can be months of medication, to ensure that it is available. But Forrey is not optimistic that the drug shortages will ease.
“Every time I think it can’t get worse, it does get worse,” he says.
Are Drug Shortages a New Normal?
Shortages are not limited to drugs for cancer or uncommon diseases. Experts fear that scarcity of the heart attack drug nitroglycerin is endangering patients’ lives. Last spring, the most basic of antibiotics, doxycycline, used for everything from acne to Lyme disease, disappeared from pharmacies. Even intravenous saline solution, a hospital staple, has been in short supply, leading some hospitals to ration their use. In fact, almost every U.S. hospital has faced a lack of basic medicine, found an American Hospital Association survey. Many have even hired a full-time staff person specifically to navigate shortages.
Hospitals have developed complex formulas to help ration existing drug supplies—essentially, to determine which patients get medication and which don’t.
“No doctor wants to prioritize,” says Richard Schilsky, MD, chief medical officer of the American Society of Clinical Oncology. “But if you have five patients and only three vials, that’s a very real problem.”
A significant shortage creep is affecting mainstays of reproductive and sexual-health medicine, from anesthetics used in gynecologic surgery to antinausea drugs for pregnancy to antibiotics for sexually transmitted diseases, says Michele Curtis, MD, an ob-gyn in Houston. “I work in the most expensive health-care system in the world, and I am being asked to do it in third world conditions,” she says.
Thirty-seven of the 38 different components used in intravenous nutrition bags have been in fluctuating shortage since spring 2009, which is a serious threat to our country’s youngest and most fragile children. Insufficient zinc, for example, has led to raw blistering sores on the tiny hands of premature infants.
“We have been compromising what we feel is optimal care for close to three years now, and we don’t really see any end in sight,” says Jay M. Mirtallo, immediate past president of the American Society for Parenteral and Enteral Nutrition.
Rolling the Dice
Doctors, patients, and regulators have jury-rigged fixes with their own hazards, using drugs that may have worse side effects or less favorable outcomes or come from unsavory wholesalers or less regulated drugmakers.
The shortages have forced Susan Agrawal, in Chicago, to make difficult decisions as she struggles to keep her nine-year-old daughter, Karuna, alive. Karuna was born with cerebral palsy due to a ruptured umbilical cord. She has since developed an autoimmune disease that causes her organs to fail. She survives by getting her nutrients intravenously and needs bags of liquid nutrition with 14 components, which Agrawal gets from a specialized sterile infusion facility.
Agrawal has had to canvass local pharmacies and drug compounders to find the ingredients that the facility can’t get. In fact, she’s even purchased drug components from a compounding pharmacy that has had repeated run-ins with state regulators for unsanitary conditions. Then she must reconstitute the components, from powder to liquid, at her dining room table, with no guarantee of sterility, and add them to her daughter’s IV bags. “It’s like, ‘Cross your fingers,’ ” she says.
Although Karuna is very sick, the fact that her IV nutrition—which shouldn’t be this complicated—is so fraught may be compromising the quality of life she has left. Agrawal fears that given her daughter’s fragile health and immune system, the shortages “will surely cause her death.”
In a survey of 1,800 health-care practitioners, about 25 percent reported errors due to shortages. Among the 1,000 incidents: a patient who died from an infection that could have been treated had the antibiotic amikacin been available, accidental overdoses of alternative drugs, and prolonged hospitalizations due to side effects from alternative drugs.
A medicine substitution sickened Sharon Brown, who was being treated for stage 2 breast cancer at Ohio State University. She was suffering relatively few side effects from her chemotherapy drug, Taxol, but then in June 2011, her doctors were unable to procure her next dose and switched her to a similar drug, Taxotere.
Two days after her first dose, she suffered a devastating reaction, an uncommon but known side effect: She grew dizzy, broke into a cold sweat, and could not lift her arms over her head. She was so dehydrated that hospital staff could not even draw blood from her veins. For the next two weeks, she needed IV fluids every other day just to treat her dehydration. She was too sick to resume chemotherapy for another month.
Even the FDA has been boxed into a corner. After the cancer drug Doxil became unavailable in late 2011, the FDA made an emergency provision to allow an Indian generic-drug company, Sun Pharma Global, to temporarily export a similar generic drug, Lipodox, which is not approved in the United States. Although patients and doctors applauded the move, Sun Pharma has faced repeated past FDA sanctions for poor quality. (In 2009, U.S. marshals raided its U.S. manufacturing plant and shut down production.)
Patients say that drugmakers have forced them into unacceptable treatment. Sufferers of Fabry disease, a rare life-threatening enzyme disorder that dangerously slows blood supply, have only the drug Fabrazyme, made by the company Genzyme, to treat their disease. But in 2009, Genzyme was forced to shut down its manufacturing plant in Allston, Massachusetts, after a viral contamination was discovered.
As Genzyme entered into a consent decree with the FDA and struggled to open a new plant, it established a rationing program. Patients would be required to take a reduced dose instead of their whole dose. If they refused, they would be given no medicine and placed at the bottom of the waiting list. A spokesperson for Genzyme says the company imposed this condition after it consulted with a working group that included doctors and patient advocates. However, patients say that the FDA did not study the impact of the diminished dose, and—more shocking—the European Medicines Agency, Europe’s main drug regulator, found that a reduced dose accelerated disease in some patients. (Genzyme spokeswoman Lori Gorski says that during the shortage, the FDA did permit patients to take an alternative drug, Replagal, made by Shire.)
In February 2012, a Pittsburgh patent lawyer, Allen Black, PhD, who had worked as a drug developer, filed a lawsuit against the FDA on behalf of patients affected by drug shortages. Those included patients with Fabry disease as well as Jennifer LaCognata, who needs Aquasol A. The lawsuit alleged that by allowing drug companies to stop making a drug, the FDA effectively allows them to make life-or-death decisions for patients. As Black says, “There’s no appeals process. You get denied a drug? Tough.” The FDA’s response offered little comfort to patients expecting help. In a motion to dismiss the lawsuit, the FDA stated that while it “works with manufacturers to help prevent and mitigate these shortages, the FDA’s authority to address potential and actual drug shortages is limited.” Last November, the court dismissed the case.
For Real Solutions, We Need Big Reform
In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which included provisions originally spearheaded by Justine Zirbes’s senator Amy Klobuchar. The law requires that drugmakers give the FDA early notification of any manufacturing issues or business decisions that may lead to shortages. It requires the FDA to expedite inspections and reviews of manufacturing sites that could help resolve shortages.
There is some evidence that the FDA has been successful in holding back the tide. In 2013, the number of new drugs added to the shortage list was far less than the number added in 2012. But in the first quarter of 2014, active shortages remained close to the highest level ever. The situation, which was the subject of a congressional hearing in February, remains “very critical,” says Erin Fox, director of the University of Utah’s drug information service.
Critics say the FDA’s response is mere window dressing that has done little to change underlying problems. “It’s fine to say that the FDA should have six months’ advance notice,” says Dr. Schilsky. But he views the new legislation as “doing nothing to address the root causes” of the problem.
Meanwhile, doctors and patients have little information about when they can expect shortages to be resolved. Despite planning and promises from drugmakers, “many resolution dates are unknown or unmet,” says Ryan Roux, chief pharmacy officer at the Harris County Hospital District in Texas.
Companies aren’t penalized for drug shortages or incentivized to avoid them, experts say. The only real solution, say a number of health-care professionals, is to require drug manufacturers to stockpile medicine and to ensure that more than one drugmaker produces it. “There needs to be a way to obligate multiple manufacturers to make these lifesaving medications,” says Ohio State’s Forrey.
The FDA would have to require that manufacturers change their just-in-time manufacturing model and set aside reserves of lifesaving drugs, which the FDA has claimed is impossible. But one executive at a pharmacy benefit-management company, who asked to remain anonymous, says the FDA could easily mandate this: “Don’t give me this stuff: ‘We can’t tell the drug companies what to do,’” he says. “Yes, you can; you do it all the time.” The FDA, with all its leverage, “could probably solve 90 percent of the problem.”
Some vital industries, such as technology and defense, encourage what is called second sourcing, in which manufacturers may sublease at least one fifth of production to backup companies to avoid supply-chain disruptions in the event of natural or other disasters. Justine Zirbes, who faced the prospect that her son Axel could have died from leukemia without cytarabine, says that manufacturers who “stop making a lifesaving drug” should be subject to criminal prosecution.
In a separate proceeding, Jennifer LaCognata sued Hospira on the grounds that the company failed to plan for contingencies in its shortage of Aquasol A. Last June, Florida’s 11th Circuit Court of Appeals dismissed the suit. Her lawyer, Allen Black, then petitioned the U.S. Supreme Court, which declined to take the case. LaCognata, whose vision continues to deteriorate and who lost her house in a foreclosure proceeding, says she has to remain strong for her kids. “I have to have a very upbeat attitude,” she says, “or it would just consume [me].”
Just recently, her lawyer was staggered to learn from a friend who works for Doctors Without Borders that a version of the vitamin A drug that LaCognata needs is being manufactured in France, sold under the name Nepalm Vitamin A. But with her financial resources depleted, her doctor reluctant to prescribe it, and her need to get a compassionate-use exemption from the FDA (so the drug can get through customs), LaCognata just has to figure out how to obtain it.
Jennifer LaCognata, 40, a booking agent for United Airlines from Safety Harbor, Florida, first suffered an attack of night blindness in early 2011. It took months to properly diagnose her. She was vitamin A deficient, due to a shortened bowel that made her body unable to absorb fat. The good news: The problem was totally fixable with injections of a basic medicine called Aquasol A, made by Hospira, an American generic drug company.
Dan Winters for Reader’s Digest
But bad news quickly followed. LaCognata learned that manufacturing challenges had forced Hospira to stop selling the drug, effectively plunging the entire world into a shortage. Without Aquasol A, LaCognata is going blind. United Airlines placed her on unpaid medical leave because she could no longer look at a computer screen. She is forced to wear an eye patch and can see only kaleidoscopic fragments out of one eye. “My kids call me Pirate now,” she says, “instead of Mom.”
LaCognata and her husband canvassed the world for Aquasol A. They contacted the Food and Drug Administration (FDA), the State Department, and every major eye hospital in America. (They found two vials, but they were expired, so hospitals wouldn’t release them.) The couple wrote and called hospitals and organizations in Israel, China, Canada, and Brazil. LaCognata contacted charities, including the Red Cross and the Helen Keller Foundation, that serve foreign populations prone to vitamin A deficiency, without luck.
A Hospira spokesperson said that the company recognized the “critical need” for Aquasol A and had contracted with a separate manufacturing company to “accelerate the product’s return to market.” But years later, the company has yet to resume its production.
It is listed on Hospira’s website as “out of stock.”
“I can’t believe this could happen in America,” LaCognata says.
Dan Winters for Reader’s Digest
A Shocking Epidemic
It seems unfathomable in our high-tech medical system, but in 2007, 154 drugs were in shortage, a number that almost tripled to 456 in 2012, according to the U.S. Government Accountability Office.
Threatening medical-care options and patients’ lives, drug shortages have occurred in almost every pharmaceutical category. Antibiotics, cancer drugs, anesthesia, pain control, reproductive and gynecological drugs, cardiac medicine, psychiatric drugs, and intravenous-feeding solutions have all been in varying degrees of short supply or not available at all. Recently, nitroglycerin, an emergency room staple used to treat heart attack patients, has been in such severe scarcity that its sole U.S. manufacturer has restricted hospitals to 40 percent of their usual orders. A study published this March in the Mayo Clinic Proceedings attributed more than 15 documented deaths since 2010 to either lack of treatment or the switch to an inferior drug as a result of medication shortages.
Though the FDA has scrambled to alleviate the crisis and physicians have become deft at juggling or substituting treatments, there is no comprehensive solution to this drug-supply breakdown, which has persisted for a complex array of reasons.
The first is all about money. As generic drug prices have dropped, so have manufacturers’ profits. As a result, some manufacturers have failed to invest in infrastructure and quality control. To ensure safety, the FDA has taken regulatory actions that have halted supplies, with sterile injectable drugs, such as pain meds and chemotherapy, dominating the shortage list. (These are the most complex and costly generics to make.) The business model of just-in-time manufacturing—in which companies make drugs as patients need them but do not stockpile extra—leaves no margin for unexpected events.
Noting that there are no shortages of big profit-generators, like Viagra, many practitioners and patients suspect less-than-honorable motives by drugmakers. Some experts suggest that manufacturers may have financial incentive to temporarily stop production of a drug. Medicare reform imposed certain price controls on generic drugs, but, due to a loophole, these controls are lifted if a manufacturer stops making the drug for six months.
Limited manufacturing capacity is an important factor too. Over half the drugs on the FDA shortage list had only one or two manufacturers, according to a report by the IMS Institute for Healthcare Informatics. Some blame hospital buying groups, middlemen that purchase drugs and supplies for many of the nation’s hospitals, which have awarded contracts to some manufacturers and not others, thereby suppressing competition and innovation. The result is that for any given drug, there may be only one or two generic manufacturers left to produce it, which can lead to shortages.
Predatory middlemen are making the situation even worse. A congressional investigation led by Rep. Elijah Cummings, a Baltimore Democrat, has found that shady secondary wholesalers buy up drugs in shortage and resell them, often at exorbitant prices. This explains, in part, the haphazard ebb and flow of the shortages that makes them particularly hard to handle: One day the medicine is just gone, but there’s plenty the next.
But as experts debate the cause of the shortages, there is no disagreement over their devastating impact. They’ve turned pharmacists into professional beggars and have forced doctors to change treatment protocols on the fly—in some cases, turning routine care into a roll of the dice. They’ve stopped clinical trials and have led to the suspension of the death penalty in some states that use lethal injection.
Shortages are leading hospitals and patients to get drugs from less regulated and potentially less safe sources, such as drug compounders, specialty pharmacies that mix medications for individual patients. Some compounding pharmacies, which are not subject to regulation as stringent as that for drug manufacturers, have taken advantage of this and started churning out large volumes of drugs. But this can lead to safety issues. Such dangers became vividly clear in 2012, after contaminated steroids from the New England Compounding Center led to an outbreak of meningitis that killed 64 patients. A 2013 report by the Health and Human Services inspector general found that drug shortages have led 68 percent of U.S. hospitals to turn to compounders to make versions of medicine in short supply.
Patients today have to cope not only with being sick or choosing between treatment options but also with the possibility that the drug they need may be available solely from a risky source—or not at all.
A Scary Reality for Cancer Patients
Those with life-threatening diseases have been hit hardest by shortages, in part because many of their medications have no substitute and their exacting treatment regimens cannot be delayed.
Justine Zirbes, 33, a TV producer in Minneapolis, was seven months pregnant with twins in October 2010 when she learned that her three-year-old, Axel, had leukemia. The distressing news sent her into early labor, and she was confined to bed.
As her son embarked on grueling chemotherapy for a disease that can often be cured if treated—but is almost certainly fatal if not—Zirbes learned that a national shortage of the chemotherapy drug cytarabine would affect his regimen. Doctors offered a drug called clofarabine, which was not standard treatment. Though still pregnant and on bed rest, Zirbes flatly refused. “How is this possible, in this country in 2011, that these lifesaving drugs are not widely available?” Zirbes recalls. “I was beside myself with disbelief.”
Zirbes was justified in her concern. According to a 2012 study in the New England Journal of Medicine, drug substitutions due to shortages led to higher relapse rates among children with an otherwise curable form of lymphoma.
Like Jennifer LaCognata, Zirbes embarked on a quest to find the right medicine. She contacted her senator Amy Klobuchar (D-MN), who took up the cause with proposed legislation. Zirbes produced two news segments on children affected by drug shortages. She worked every connection she had and looked as far away as Europe to find her son’s drug. Ultimately, the day before Axel was due for treatment, the hospital got enough cytarabine to treat him and another child.
Axel was reasonably lucky. Other patients, like Carey Fitzmaurice of Bethesda, Maryland, almost certainly suffered recurrence of their cancer because of drug shortages.
In 2006, Fitzmaurice, 37, was happily married with two young children and a job she loved as a policy analyst at the Environmental Protection Agency, when she learned that she had ovarian cancer and a BRCA1 genetic mutation that had likely caused it.
Over five years, she bravely underwent debilitating treatment, a recurrence of her ovarian cancer, an additional diagnosis of breast cancer, and a radical mastectomy. In the middle of 2011, things finally seemed to be breaking her way. Her breast cancer was in remission, and a chemotherapy drug called Doxil, made by a contractor for the Johnson & Johnson subsidiary Janssen, Inc., appeared to be vanquishing a recurrence of the ovarian cancer. But in August 2011, she learned there was not enough Doxil to complete her treatment.
Fitzmaurice assumed that she would be able to find some on her own. “I work for the federal government,” she says. “A lot of what I do is help people cut through red tape and find solutions. That’s how I tackled cancer to begin with: find out who the right doctor is, where to get surgery.”
But the shortage of Doxil thwarted her every effort. After four months without the medication, her ovarian cancer returned.
In a recent study from the University of Pennsylvania presented at the 2013 annual meeting of the American Society of Clinical Oncology, 83 percent of oncologists and hematologists said they’ve faced cancer drug shortages, and of those, nearly all said their patients’ treatment had been affected by drug shortages.
At the Ohio State University Comprehensive Cancer Center in Columbus, Ohio, Ryan Forrey, associate director for pharmacy and infusion services, says that in 2012, of the 60,000 doses of chemotherapy administered intravenously at his facility, almost 35 percent were affected by shortages. Treatment was interrupted or canceled, patients were switched to alternative drugs, or an alternative supply for the needed drug had to be found. His overwhelmed staff “was forced to beg, borrow, plead to get drugs for patients,” he says.
Now, whenever a patient begins chemotherapy, Forrey’s hospital sequesters the entire treatment regimen, which can be months of medication, to ensure that it is available. But Forrey is not optimistic that the drug shortages will ease.
“Every time I think it can’t get worse, it does get worse,” he says.
Are Drug Shortages a New Normal?
Shortages are not limited to drugs for cancer or uncommon diseases. Experts fear that scarcity of the heart attack drug nitroglycerin is endangering patients’ lives. Last spring, the most basic of antibiotics, doxycycline, used for everything from acne to Lyme disease, disappeared from pharmacies. Even intravenous saline solution, a hospital staple, has been in short supply, leading some hospitals to ration their use. In fact, almost every U.S. hospital has faced a lack of basic medicine, found an American Hospital Association survey. Many have even hired a full-time staff person specifically to navigate shortages.
Hospitals have developed complex formulas to help ration existing drug supplies—essentially, to determine which patients get medication and which don’t.
“No doctor wants to prioritize,” says Richard Schilsky, MD, chief medical officer of the American Society of Clinical Oncology. “But if you have five patients and only three vials, that’s a very real problem.”
A significant shortage creep is affecting mainstays of reproductive and sexual-health medicine, from anesthetics used in gynecologic surgery to antinausea drugs for pregnancy to antibiotics for sexually transmitted diseases, says Michele Curtis, MD, an ob-gyn in Houston. “I work in the most expensive health-care system in the world, and I am being asked to do it in third world conditions,” she says.
Thirty-seven of the 38 different components used in intravenous nutrition bags have been in fluctuating shortage since spring 2009, which is a serious threat to our country’s youngest and most fragile children. Insufficient zinc, for example, has led to raw blistering sores on the tiny hands of premature infants.
“We have been compromising what we feel is optimal care for close to three years now, and we don’t really see any end in sight,” says Jay M. Mirtallo, immediate past president of the American Society for Parenteral and Enteral Nutrition.
Rolling the Dice
Doctors, patients, and regulators have jury-rigged fixes with their own hazards, using drugs that may have worse side effects or less favorable outcomes or come from unsavory wholesalers or less regulated drugmakers.
The shortages have forced Susan Agrawal, in Chicago, to make difficult decisions as she struggles to keep her nine-year-old daughter, Karuna, alive. Karuna was born with cerebral palsy due to a ruptured umbilical cord. She has since developed an autoimmune disease that causes her organs to fail. She survives by getting her nutrients intravenously and needs bags of liquid nutrition with 14 components, which Agrawal gets from a specialized sterile infusion facility.
Agrawal has had to canvass local pharmacies and drug compounders to find the ingredients that the facility can’t get. In fact, she’s even purchased drug components from a compounding pharmacy that has had repeated run-ins with state regulators for unsanitary conditions. Then she must reconstitute the components, from powder to liquid, at her dining room table, with no guarantee of sterility, and add them to her daughter’s IV bags. “It’s like, ‘Cross your fingers,’ ” she says.
Although Karuna is very sick, the fact that her IV nutrition—which shouldn’t be this complicated—is so fraught may be compromising the quality of life she has left. Agrawal fears that given her daughter’s fragile health and immune system, the shortages “will surely cause her death.”
In a survey of 1,800 health-care practitioners, about 25 percent reported errors due to shortages. Among the 1,000 incidents: a patient who died from an infection that could have been treated had the antibiotic amikacin been available, accidental overdoses of alternative drugs, and prolonged hospitalizations due to side effects from alternative drugs.
A medicine substitution sickened Sharon Brown, who was being treated for stage 2 breast cancer at Ohio State University. She was suffering relatively few side effects from her chemotherapy drug, Taxol, but then in June 2011, her doctors were unable to procure her next dose and switched her to a similar drug, Taxotere.
Two days after her first dose, she suffered a devastating reaction, an uncommon but known side effect: She grew dizzy, broke into a cold sweat, and could not lift her arms over her head. She was so dehydrated that hospital staff could not even draw blood from her veins. For the next two weeks, she needed IV fluids every other day just to treat her dehydration. She was too sick to resume chemotherapy for another month.
Even the FDA has been boxed into a corner. After the cancer drug Doxil became unavailable in late 2011, the FDA made an emergency provision to allow an Indian generic-drug company, Sun Pharma Global, to temporarily export a similar generic drug, Lipodox, which is not approved in the United States. Although patients and doctors applauded the move, Sun Pharma has faced repeated past FDA sanctions for poor quality. (In 2009, U.S. marshals raided its U.S. manufacturing plant and shut down production.)
Patients say that drugmakers have forced them into unacceptable treatment. Sufferers of Fabry disease, a rare life-threatening enzyme disorder that dangerously slows blood supply, have only the drug Fabrazyme, made by the company Genzyme, to treat their disease. But in 2009, Genzyme was forced to shut down its manufacturing plant in Allston, Massachusetts, after a viral contamination was discovered.
As Genzyme entered into a consent decree with the FDA and struggled to open a new plant, it established a rationing program. Patients would be required to take a reduced dose instead of their whole dose. If they refused, they would be given no medicine and placed at the bottom of the waiting list. A spokesperson for Genzyme says the company imposed this condition after it consulted with a working group that included doctors and patient advocates. However, patients say that the FDA did not study the impact of the diminished dose, and—more shocking—the European Medicines Agency, Europe’s main drug regulator, found that a reduced dose accelerated disease in some patients. (Genzyme spokeswoman Lori Gorski says that during the shortage, the FDA did permit patients to take an alternative drug, Replagal, made by Shire.)
In February 2012, a Pittsburgh patent lawyer, Allen Black, PhD, who had worked as a drug developer, filed a lawsuit against the FDA on behalf of patients affected by drug shortages. Those included patients with Fabry disease as well as Jennifer LaCognata, who needs Aquasol A. The lawsuit alleged that by allowing drug companies to stop making a drug, the FDA effectively allows them to make life-or-death decisions for patients. As Black says, “There’s no appeals process. You get denied a drug? Tough.” The FDA’s response offered little comfort to patients expecting help. In a motion to dismiss the lawsuit, the FDA stated that while it “works with manufacturers to help prevent and mitigate these shortages, the FDA’s authority to address potential and actual drug shortages is limited.” Last November, the court dismissed the case.
For Real Solutions, We Need Big Reform
In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which included provisions originally spearheaded by Justine Zirbes’s senator Amy Klobuchar. The law requires that drugmakers give the FDA early notification of any manufacturing issues or business decisions that may lead to shortages. It requires the FDA to expedite inspections and reviews of manufacturing sites that could help resolve shortages.
There is some evidence that the FDA has been successful in holding back the tide. In 2013, the number of new drugs added to the shortage list was far less than the number added in 2012. But in the first quarter of 2014, active shortages remained close to the highest level ever. The situation, which was the subject of a congressional hearing in February, remains “very critical,” says Erin Fox, director of the University of Utah’s drug information service.
Critics say the FDA’s response is mere window dressing that has done little to change underlying problems. “It’s fine to say that the FDA should have six months’ advance notice,” says Dr. Schilsky. But he views the new legislation as “doing nothing to address the root causes” of the problem.
Meanwhile, doctors and patients have little information about when they can expect shortages to be resolved. Despite planning and promises from drugmakers, “many resolution dates are unknown or unmet,” says Ryan Roux, chief pharmacy officer at the Harris County Hospital District in Texas.
Companies aren’t penalized for drug shortages or incentivized to avoid them, experts say. The only real solution, say a number of health-care professionals, is to require drug manufacturers to stockpile medicine and to ensure that more than one drugmaker produces it. “There needs to be a way to obligate multiple manufacturers to make these lifesaving medications,” says Ohio State’s Forrey.
The FDA would have to require that manufacturers change their just-in-time manufacturing model and set aside reserves of lifesaving drugs, which the FDA has claimed is impossible. But one executive at a pharmacy benefit-management company, who asked to remain anonymous, says the FDA could easily mandate this: “Don’t give me this stuff: ‘We can’t tell the drug companies what to do,’” he says. “Yes, you can; you do it all the time.” The FDA, with all its leverage, “could probably solve 90 percent of the problem.”
Some vital industries, such as technology and defense, encourage what is called second sourcing, in which manufacturers may sublease at least one fifth of production to backup companies to avoid supply-chain disruptions in the event of natural or other disasters. Justine Zirbes, who faced the prospect that her son Axel could have died from leukemia without cytarabine, says that manufacturers who “stop making a lifesaving drug” should be subject to criminal prosecution.
In a separate proceeding, Jennifer LaCognata sued Hospira on the grounds that the company failed to plan for contingencies in its shortage of Aquasol A. Last June, Florida’s 11th Circuit Court of Appeals dismissed the suit. Her lawyer, Allen Black, then petitioned the U.S. Supreme Court, which declined to take the case. LaCognata, whose vision continues to deteriorate and who lost her house in a foreclosure proceeding, says she has to remain strong for her kids. “I have to have a very upbeat attitude,” she says, “or it would just consume [me].”
Just recently, her lawyer was staggered to learn from a friend who works for Doctors Without Borders that a version of the vitamin A drug that LaCognata needs is being manufactured in France, sold under the name Nepalm Vitamin A. But with her financial resources depleted, her doctor reluctant to prescribe it, and her need to get a compassionate-use exemption from the FDA (so the drug can get through customs), LaCognata just has to figure out how to obtain it.
Poppy Seed Drug Test?? Just From Eating A Bagel, What?
5 Protein Rich Foods You Didn’t Know About
Protein is an important nutrient for our body, it almost helps in every part and process of our body, from nails and hairs to skin and bones. Everything involves proteins in one way or another.
So it is very important to include such a beneficial nutrient in your daily diet plan and then eat accordingly. While many of you know meat and eggs as the protein rich foods, but there are more alternatives than these two, and this article is about sharing those alternatives with you.
#1: Beans
Beans have a good amount of proteins in them. You can have beans in many forms, like with different vegetable and you can also cook them in soup. This option is also very good for the vegans, they can have their fair share of protein by adding beans to their diet.
#2: Green Peas
Many people hate green vegetable (Even though most of them are green), but hating green peas means declining yourself a great source of protein.
There is another benefit of these green peas, along with being a good protein source, they are very cheap and almost anyone can afford to add green peas in their diet. They are not so hard and difficult to cook also. In short, this is a budget friendly, healthy and delicious protein source.
#3: Chia Peas
No one thought that these peas can be such a source of protein that we would have added them in our list. They are a great protein source, and helps you in digestion process also. Uniqueness of this alternative is that you can use them with any food, mostly with fruit salad and similar foods.
Chia peas can be taken after food as a desert, so even if you didn’t ate healthy dinner, you can have chia peas to get the required protein as a dessert. Cool and Healthy.
#4: Greek Yogurt
Yummy. #4 source of protein in our list is Greek yogurt. Because it is also a great source of protein and you can have it on the go also, you can also have it to dip your snacks in It and then eat this yummy Greek Yogurt.
About 15 to 20 grams of Greek yogurt per 6-ounce container will provide you the amount of protein for a full day.
#5: Cottage Cheese
Cottage cheese is not as exciting a source of protein as other sources mentioned above, but do not think that it is a bad source of protein.
Cottage cheese is an amazing source of protein, and it is also a low fat food, which means that you can have it without any tension. Enjoy cottage cheese with spinach and use it as a comfort food.
Are You Being Tricked By These Food Industry Marketing Tactics?
The countless commercials touting Subway’s new “Fritos Chicken Enchilada Melt” have gotten so ridiculous, I am about to lose my mind. A member of the Food Babe Army sent me leaked photos of the ingredient list of this highly processed sandwich. The full ingredient list is below – you don’t want to miss this. Read More: http://foodbabe.com/2014/03/05/are-you-being-tricked-by-these-food-industry-marketing-tactics/
A Little Girl’s Project Shows Us Why We Need To Choose Organic Produce
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As part of a simple school project a young student by the name of Elise was tasked with discovering how long it would take for a fully grown sweet potato to grow vines. The project itself is quite simple, and is a regular part of many elementary school curriculum’s since all that it involves is the sticking of toothpicks into the sweet potato and the suspension of it into a glass of water. If left near a window that receives sunlight the sweet potato should grow vines, which is the exact process that Elise was looking to monitor. (Click HERE for an exact step-by-step guide on how to do this)
Elise’s discovery however went a lot further than this when she initially purchased sweet potato failed to grow vines after three weeks of following the given instructions. Here is the full video featuring Elise’s discovery:
What initially started as a simple science experiment quickly evolved into a potent and unintentional piece of evidence in support of the purchase of organic rather than conventional produce. As Elise so adorably mentioned as a part of her explanation, the conventional sweet potato was sprayed with bud nip, alternatively known as Chlorpropham. Bud nip is just one of the many chemicals widely used in non-organic farming and agriculture.
What initially started as a simple science experiment quickly evolved into a potent and unintentional piece of evidence in support of the purchase of organic rather than conventional produce. As Elise so adorably mentioned as a part of her explanation, the conventional sweet potato was sprayed with bud nip, alternatively known as Chlorpropham. Bud nip is just one of the many chemicals widely used in non-organic farming and agriculture.
What Is Bud Nip?
Bud Nip is a plant growth regulator used for the control of grass weeds on several fruit and vegetable plants. In potatoes, such as the sweet potatoes that we conventionally purchase, bud nip is used primarily to inhibit potato sprouting -the exact process that Elise was looking to create as a part of her experiment. On the surface bud nip seems relatively harmless, however certain studies show that it also comes with a fair level of potential side effects -many of which Elise mentions -that do more than an adequate job at justifying the ‘caution’ warning that it is labelled with. Bud nip is considered moderately toxic for ingestion, an irritant for the eyes and skin and was responsible for a number of side effects and even death of several of the animals that it was tested on. Despite this, bud nip is regularly used directly on an abundance of non-organic produce, and indirectly on other produce due to its highly soluble nature in both soil and groundwater. This could potentially explain how even the organic sweet potato that Elise had purchased from the conventional grocery store did not sprout nearly as impressive as the final one that she had purchased from the organic food market. Elise’s experiment serves as a simple yet profound reminder of the option that we have to grow or purchase organic produce. It may currently be the more expensive of the two product options that exists, but when it involves our health it certainly cannot be overlooked.
Read more about fruits and vegetables you should always buy organic...
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Top 10 Most Common GMO Foods
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Support Local Food! Please Share...
Genetically Modified Organisms (referred to as GM or GMO) are found in up to 80% of the food sold in American supermarkets. GM plants are much more common than many people realize too. Here is a list of the 10 most common GMO foods so you can be more aware while grocery shopping.
1. Soy
Up to 90% of soybeans in the market have been genetically modified to be resistant to an herbicide called, RoundUp. This increased resistance to the herbicide allows farmers to use more RoundUp to kill weeds. However, this results not only in a genetically modified food product, but also a food product loaded with more chemicals.
2. Corn
Half of the US farms growing corn to sell to the conglomerate, Monsanto, are growing GMO corn. Most of this corn is going to be used for human consumption. Genetically modified corn has been linked to health problems, including weight gain and organ disruption.
3. Canola oil
Canola oil is derived from rapeseed oil. It is considered one of the most chemically altered oils sold in the US.
4. Cotton
Even cotton has been genetically modified to increase yield and resistance to disease. Most concern relates to the cotton oil which is a is a high-value cooking or frying oil and is sometimes used to make margarine. Cotton originates from India, and China, in particular, is considered higher risk for personal health.
5. Milk
One fifth of the dairy cows in the United States has been given growth hormones to help them grow faster and increase their yield. These hormones can be found in some of the milk produced by these cows. These growth hormones have been shown to act in the human body.
6. Sugar
Genetically modified sugar beets were introduced to the US market in 2009. These sugar beets are modified to resist Roundup, like corn.
7. Aspartame
Aspartame is an artificial sweetener used instead of sugar by many people. There is some question concerning the safety of aspartame in the body, including its possible link to certain cancers. Aspartame is manufactured from genetically modified bacteria.
8. Zucchini
Genetically modified zucchini contains a toxic protein that helps make it more resistant to insects. This introduced insecticide, has recently been found in human blood, including that of pregnant women and fetuses. This indicates that some of the insecticide is making its way into our bodies rather than being broken down and excreted.
9. Yellow squash
Yellow squash has also been modified with the toxic proteins to make it insect resistant. This plant is very similar to zucchini, and both have also been modified to resist viruses.
10. Papaya
Genetically modified papaya trees have been grown in Hawaii since 1999. These Papayas are sold in the United States and Canada for human consumption. These papayas have been modified to be naturally resistant to the Papaya Ringspot virus, and also to delay the maturity of the fruit. Delaying maturity gives suppliers more time to ship the fruit to supermarkets.
These are just 10 of the most prevalent GMO foods found in the supermarket. There are many others currently for sale and being grown for the market. If you want to stay away from GMOs, always keep an eye out for a label that indicates food is organic or non-GMO.
DISCLAIMER
Last ingredient on any cooking spray - propellant
What exactly is propellant? According to the Times it includes “petroleum gas, propane, and butane.” How about a little side of that with your pancakes! It pays to read labels!
Homemade nonstick cooking spray. Healthy and get rid of all the chemicals that are in Pam! Have to make this since I just discovered there is propane in Pam!!!!!
HOMEMADE COOKING SPRAY
Ingredients
1 part olive oil (or your choice of oil)
5 parts water
1 misting spray bottle
Instructions
Mix in your spray bottle 1 part olive oil to 5 parts water. In a 12 ounce bottle, pour in 2 ounces of olive oil and add 10 ounces of water. Shake well and you’re done. That’s it. Store in a cool, dark place.
Source: www.onegoodthingbyjillee.com
☆ HAVE A BLESSED Day ☆
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PLEASE SHARE
To SAVE this recipe so that you can find it later, be sure to click SHARE. It will store on your personal page and make it easier for you to find it again later!!!!
For more healthy recipes, weight management advice, tips, motivation, fun and support join us here: Thin and Healthy with Darrell
We are always sourcing and creating great recipes (such as Vegan, Diabetic, Gluten Free, Weight Watchers, Low Carb, Low Fat, Low Calorie, Vegan, Heart Healthy and many more) so click the join button and come on in!!
Homemade nonstick cooking spray. Healthy and get rid of all the chemicals that are in Pam! Have to make this since I just discovered there is propane in Pam!!!!!
HOMEMADE COOKING SPRAY
Ingredients
1 part olive oil (or your choice of oil)
5 parts water
1 misting spray bottle
Instructions
Mix in your spray bottle 1 part olive oil to 5 parts water. In a 12 ounce bottle, pour in 2 ounces of olive oil and add 10 ounces of water. Shake well and you’re done. That’s it. Store in a cool, dark place.
Source: www.onegoodthingbyjillee.com
☆ HAVE A BLESSED Day ☆
¯¯¯¯¯¯¯¯ ღ☆ღ ¯¯¯¯¯¯¯¯¯
PLEASE SHARE
To SAVE this recipe so that you can find it later, be sure to click SHARE. It will store on your personal page and make it easier for you to find it again later!!!!
For more healthy recipes, weight management advice, tips, motivation, fun and support join us here: Thin and Healthy with Darrell
We are always sourcing and creating great recipes (such as Vegan, Diabetic, Gluten Free, Weight Watchers, Low Carb, Low Fat, Low Calorie, Vegan, Heart Healthy and many more) so click the join button and come on in!!
What's In Our Food
Easy Ways to Change the Food System
Find organic, local foods
Find locally grown produce, Community Supported Agriculture programs, and even great organic restaurants with the Eat Well Guide. Type in your zip code and find out what’s in season near you. Find out more at EatWellGuide.org.
Factory Farming
Nearly all of the approximately 10 billion animals raised and killed in the US annually suffer inhumane conditions at industrial farms. Not to mention the workers and surrounding communities that are affected by the unsafe conditions. Find out more at HumaneSociety.org.
Pesticides
Cancers, autism and neurological disorders have all been associated with the use of pesticides. Learn about what pesticides are in your food and their effects. Find out more at WhatsOnMyFood.org.
Environmental Impact
Did you know that the average food product travels about 1,500 miles to get to your grocery store? And that transporting food accounts for 30,800 tons of greenhouse gas emissions every year? Find out more at CoolFoodsCampaign.org.
For more actions you can take to fix our food system, click on the gallery below.
9 Ways to Fix the Food System
Be A Conscious Consumer
Conventional farming uses engineered fertilizers and pesticides that pollute drinking water, contaminate animal and human habitats, and diminish the nutrients from the soil.
Organic farming uses no engineered products so it produces no harmful run off and organic soil allows plants to sustain themselves more successfully in a drought than conventionally sprayed plants. Organic farming utilizes fertilizers such as cow manure and compost, these fertilizers actually add minerals and can, over time, help damaged soil become healthy again. A more complete eco system can thrive around an organic farm.
The quality of the Earth’s water supply is diminishing as global population rises to over seven billion people. Conventional farming methods are contaminating precious water supplies via run off of concentrated fertilizers and pesticides. These chemicals are seeping into human and animal water supplies and infecting our bodies. Organic farming is a water saving grace. No concentrated chemicals are used to spray crops and water sources around the farms are allowed to flourish with plant and animal life. By switching from conventional to organic it may be possible to reverse the damage done by the engineered framing. In an era of where global population is steadily increasing and the quality fresh water supply is steadily decreasing it is critical time to make organic farming the standard. 
These harmful substances are on the conventionally grown foods we eat, are fed to the conventionally raised livestock we eat, and seeping into the earth. Organic farming utilizes fertilizers that occur naturally from human, animal, and plant waste. Organic fertilizers do not contain concentrated amounts of chemicals proven to cause health problems.
The elements that harm our bodies and water are also harming the soil. Soils that are continuously sprayed with fertilizers and pesticides used in conventional farming are depleted in minerals and lack the ability to sustain plants in a drought. A healthy soil contains over 50 essential vitamins and minerals that are absorbed by a plant growing in the soil, those vitamins and minerals are then transferred to a human or animal body when they eat the produce. Since spray agriculture has become the standard in America, American people are seriously lacking essential vitamins and minerals. A conventionally grown piece of produce will not contain more than 10 essential vitamins and minerals. These are called essential vitamins and minerals because humans need to consume all of them in order to stay healthy.
Submitted Article From Ashley Lauren Heil
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