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FDA

 by Victoria Santalesa

FDA Aims To Reduce Death From Nicotine

It seems that everything we buy these days has been revamped in some way. Our cereal has less sugar, our cheese has less fat, our juice has more vitamins, what about our cigarettes? Cigarettes have never been the healthiest item on our shopping list, should we try and make them healthier? It wouldn’t be the first such attempt, there are herbal cigarettes on the markets, as well as E-Cigs aimed at maintaining the elements of cool without the element of danger. Now it seems the FDA is stepping in with its own attempt at making cigarettes healthier. Could this be a show of some much needed serious muscle? Here’s a look at reduced nicotine cigarettes and their long term implications.

Reduced Nicotine
There is reduced fat, we reduced calories, why not reduce nicotine?The US Food and Drug Administration is aiming to lower the nicotine content in cigarettes in the years to come in an effort that health officials believe may reduce the amount of tobacco related disease and illness.

The FDA announced the plan targeting nicotine as an ingredient responsible for causing dependence and health complications, and hope that lowering the nicotine levels in cigarettes will lead to a decrease in dependence on cigarettes, and lower the rates of tobacco related disease.

vine vera banner presents FDA Aims To Reduce Death From Nicotine

Less Nicotine Means Less Addiction
FDA Commissioner Scott Gottlieb explains the move. “The overwhelming amount of death and disease attributable to tobacco is caused by the addiction to cigarettes, the only legal consumer product that, when used as intended, will kill half of all long term users. Unless we change course, 5.6 million young people alive today will prematurely die later in life from tobacco use. Envisioning the world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources needs to be the cornerstone of our efforts-and we believe it’s vital that we pursue this common ground.”

Although the change will effect people of all ages, the FDA notes a particular focus on young people. Most people begin the smoking habit before the age of 18, it is especially crucial that the lowering of nicotine levels in cigarettes prevent a dependance on cigarettes from forming at an early age and lasting into later life.

The Facts On Tobacco
On the bright side, it seems that some of the anti tobacco strategies seem to be working. Tobacco has reached all time lows in teens and adults. However, it still remains the leading cause of preventable death in the United States, resulting in 480,000 deaths a year. The Centers for Disease Control Prevention blame smoking as a cause of cancer, diabetes, heart and lung disease, stoke and chronic obstructive pulmonary diseases, such as chronic bronchitis and emphysema. The FDA believes and hope reducing the level of nicotine in cigarettes will be an effective way in reduction dependence.

What’s your take? Do you think this new strategy can work? Let us know what you think of the kinder, gentler cigarette.

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Pills and medicine on wooden table
 by Victoria Santalesa

What It Takes To Get A New Drug Approved

How many of us trust our federal government? According to Pew Research, only 19% of Americans today say they can trust our government to do what is right “just about always.” So, if we don’t know it we can trust our government, how do we know we can trust our government agencies? Take, for example, the FDA. While we’d like to think that the agency responsible for approving the drugs that we bring into our home and give to ourselves and our family holds itself to higher standards than the government for which it works, how can we be sure? Let’s take a look at the prescription drug approval process in the US to see just how trustworthy it is.

The Lowdown
According to a report published in the medical journal JAMA, 32% or FDA approved drugs already in use between 2001 and 2010 “were affected by a postmarket safety event,” meaning the safety of these drugs was questionable even though they had already been placed on the market. Events varied between announcements about recently discovered side effects to outright withdrawal of drugs due to reports of fatalities. In tandem with the release of this report comes the consideration by the Trump administration to streamline and shorten the approval process. According to internist Joseph Ross, one of the study’s authors, ” Our data show that there are some cautionary predictors of increased likelihood of the FDA taking a safety action in the postmarket setting. This information should be taken into account as the FDA considers conditions of approval and when further clinical trials should be required to better understand drug safety.”

Researcher working in lab

Revelations of the JAMA Investigation

  • Of the 222 FDA approved drugs 71 led to a safety event with three resulting in outright withdrawals. Sixty-one of these drugs qualified for “black-box warnings,” or warning labels posted on the packaging of the drug framed in black rule “designed to call attention to serious of life-threatening risks.”
  • Psychiatric treatment drugs and biologics that were given accelerated approval and drugs that got approval around the time of a regulatory deadline were most likely to require warnings after hitting the market.
  • These events highlight “the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.”

Especially affected by these findings are older Americans, as many of the drugs spotlighted in the study have potential risks that won’t come to light for years. For example, revolutionary treatments of ailments such as rheumatoid arthritis, cancer, and Crohn’s disease are among those currently being researched for the long-term impact on the population because accelerated approval drugs are considered more urgently needed, research about these drugs often takes a backseat and may not qualify for approval in time to meet the needs of more mature patients.

Implications
President Barack Obama signed the 21st Century Cures Act last December to speed up the approval process for certain drugs, a process President Donald Trump referred to as “slow and burdensome,” claiming it was hindering medical advances from reaching needy patients. According to Ross, “Speeding up approval even further will not be without consequence. There will be more uncertainty at the time of approval, endless that is known about a new therapy’s safety as well as its anticipated benefits.

Are you shocked by these findings? Not surprised? Let us know what you think and what you think should be done. We want to hear from you.

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Woman checking pills
 by Victoria Santalesa

A List Of Items To Toss From Your Medicine Cabinet ASAP

Humorist and author Erma Bombeck once famously wrote, “My theory on housework is, if the item doesn’t multiply, smell, catch fire, or block the refrigerator door, let it be.” Operating on this logic, one could make a case for neglecting to clean out the medicine cabinet. After all, it’s highly unlikely you’ll find your antibiotics overrun with germs, right? Although there may be some attractive qualities to this theory, there may be some detriments to leaving your medicine cabinet unexamined for too long. The AMA recommends that you clean out your medicine cabinet once a year, and with spring cleaning upon us, this may be an ideal time. Here are some guidelines on doing just that.

What to Discard
Sara Bingel, PharmD, clinical pharmacist at Mount Sinai Hospital says, “In general, I would say many oral medications are safe to take a year or two beyond their marked expiration date.”

Items to save after expiration include pain relievers, allergy medications, like Benadryl, aspirins, stomach medications, like Tums, headache pills, and cold and flu pills.

Items to toss include itroglycerine for chest pain, life saving medications, antibiotics, liquid/suspension medications, and children’s meds.

Life-saving Drugs
When it comes to lifesaving drugs, it is crucial to heed expiration dates. The FDA requires medication manufacturers to find out how long it takes for drugs to reach a potency of 95%; after that, it is expired. That means that, when it comes to life saving meds, it’s all about getting the right amount into your body. Says Michael J. Negrete, PharmD., “I might be willing to roll the dice with cough syrup. It’s no big deal if the potency is down and it doesn’t help my cough. But imagine, with an Epi-pen, which keeps people from going into anaphylactic shock, not working.”

Woman at medicine cabinet

Store Meds Well
Expiration dates operate on the assumption that the unopened package is being kept in a cool, dry, dark place. While an untampered with package of Benedryl stored in a dark drawer in dry conditions is likely to be effective for years after its expiration date, one stored in a humid bathroom may be a very different story.

Take Visual Cues
When it comes to determining what to throw out of your medicine cabinet, there are some things you can judge for yourself. You don’t want to take a pill that crumbles in your hand and ineffective aspirin tends to smell like vinegar. Negrete advises that you, “Be suspicious of anything that looks out of the ordinary.”

Hold On To Solids, Lose the Liquids
Liquids, gels, and suspensions (in which the active ingredients is suspended in a liquid) tend to lose their potency more easily than pills and are also at risk of bacteria contamination, Bingel says, “Think rancid milk.”

Toss Children’s Meds
Paul Langevin, MD., director of cardiac anesthesiology at Waterbury Hospital comments, “Because children are smaller and their metabolic systems aren’t fully developed, I wouldn’t hang on to kids’ meds past the expiration date. Plus, a lot of medications for children are prepared in suspensions so the kids will take them and those flavored liquids can decompose and acquire bacterial growth.”

Are you cleaning out your medicine cabinet once a year? When the last time you went through your meds was.

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Roast chicken and toast on table
 by Victoria Santalesa

Your Chicken Should Be Antibiotic Free

The dating world can be scary these days. Everyone is looking to have Fun Ways To Move Morefun, but when it comes to starting long term relationships, you need to know some vital information about your partner’s past. After all, if your going to be putting parts of a person’s body into your body, you need to know where those body parts have been. The same can be said of your chicken. If that chicken is going to be in your mouth and stomach, you should know a little about this chicken, especially whether of not this chicken is antibiotic free. Why? Read on to find out.

Harmful to Human Health
The use of antibiotic on farm animals have been amped up in recent years. Fifteen to seventeen million pounds go the drug are freely administered on a yearly basis. The goal of this is not only to keep animal healthy in general, but also to prevent sickness in animals raised in unsanitary conditions. The results have been anything but healthful. The overuse of antibiotics has resulted in the evolution of antibiotic resistant bacteria strains, superbugs, if you will, and, since poultry products usually carry more than one bacterial strain, it is becoming more likely the meat you buy is contaminated.

In fact, a recent study from the Environmental working group found that 81% of ground turkey, 69% of pork chops, 55 % of ground beef, and 39% of chicken wings and thighs are tainted with antibiotic-resistant strains of bacteria like E. coli and salmonella.

Add to that the fact that the antibiotics used to treat chicken are similar to those that are used on humans and the threat to public health increases. Dr. Glenn Morris says that humans who ingest the resistant bacteria may not respond to antibiotic treatment. The risk for children is higher due to less mature immune systems.

Happy hens

Government Response
It would not be an exaggeration to say our government’s response to this danger was underwhelming. In 2013, the FDA declared a “voluntary strategy” asking that drug companies limit the amount of antibiotics in animal feed. While the association released a statement acknowledging the use of antimicrobial drugs as “an important health concern,” and recommended “judicious use of the drugs, the call carries no penalty for failure to comply and is open to ambiguous interpretation.

Antibiotic Chicken
Despite the weak response from the FDA, consumers can be proactive in avoiding the consumption of contaminated chicken. A 2012 Consumer Reports studies found antibiotic free products at 119 stores, including, Whole Foods, and Trader Joe’s. The “no antibiotics” chickens were reasonably priced and, in some cases, actually cost less than the average price of chicken breasts nation-wide. Panera Bread is a leading restaurant in the increasing availability of antibiotic-free products, including chicken, pork. and turkeys, a trend that we will hopefully be seeing more of in the near future. Until then, you can keep yourself informed at RealTimeFarms.com.

What are you doing to avoid eating unhealthy foods? Let us know! We want to hear your recommendations and suggestions!

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Grilled cod fish and vegetables
 by Victoria Santalesa

Updated Advice For Eating Fish While Pregnant

Fans of Lucille Ball may remember episodes of “I Love Lucy” in which Lucy was pregnant with “Little Ricky.” One such episode played on the stereotypical craving of the pregnant women, with Lucy sending Ricky out in the middle of the night to find a store that makes a papaya milkshake, sardines to mix in and a pickle to dip in the concoction. The episode ends with Lucy switching the recipe to sardines with pistachio ice cream and hot fudge. (Take that, Ben and Jerry.) Apparently, Lucille Ball never ate sardines again.

Over the years, there has been a lot of debate about the sagacity of eating fish while pregnant. Recently the Federal government has issued new advice that may have made Lucy think twice before she gave up on the sardines.

New Findings
You may be familiar with the guidelines issued by the FDA recommending maximum amounts of fish that pregnant and breastfeeding women should consume, but you may not be aware, that the groups are now promoting a minimum amount as well. Apparently, new scientific findings uncovered evidence that the importance of pregnant and breastfeeding women and young children eating appropriate amounts of fish needs to be underscored.

According to Stephen Ostroff, MD, and acting chief scientist for the FDA, “Emerging science now tells us that limiting or avoiding fish during pregnancy and early childhood can mean missing out on important nutrients that can have a positive impact on growth and development as well as on our general health.”

Woman on sofa

How Much Is Enough?
An FDA analysis of over 1,000 women revealed that 21% ate no fish in the previous month and that those who did ate far less than is recommended by the Dietary Guidelines for Americans. The updated draft recommends that pregnant women eat between 8-12 ounces per week of a variety of low-mercury fish for healthy fetal development.

Nancy Stoner, the EPA’s acting administrator for the Office of Water says, “Eating fish with lower levels of mercury provides numerous health and dietary benefits. This updated advice will help pregnant women and mothers make informed decisions about the right amount and right kinds of fish to eat during important times in their lives and their children’s lives.”

What Kind Of Fish Is Best? Worst?
Included in the draft is advice cautioning breastfeeding and pregnant women against fish known to contain high mercury levels. Such fish include swordfish, shark, king mackerel, and tilefish from the Gulf of Mexico. The women are also advised to limit consumption of white tuna to 6 ounces a week. Less mercurial and recommended options include pollock, salmon, shrimp, canned light tuna, catfish, cod, and tialpia. Women are also instructed to follow fish advisories from local authorities, if available. If such information is not available, women are advised to limit intake of fish to 6 ounces a week for themselves and 1 to 3 ounces for children.

What do you think about the new guidelines? Let us know! Do you know something we don’t?

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