Pills and medicine

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.

Don't Let Motion Sickness Get You Down

Planning a getaway this summer? Maybe you’re contemplating a little cruise on the Atlantic, a cross-country car trip, or maybe your plans involve a long international plane ride. You packed some snacks, put together a CD playlist, the kids have their iPod, and you even googled travel games on the computer in case the Wi-Fi goes out. You’ve done everything you can to make sure the trip goes off without a hitch. But, as they say, it’s all fun and games, until someone gets motion sickness.

What is Motion Sickness?
Motion sickness may go right up there with deja vu when it comes to examples of the human brain working in mysterious ways. While exact causes of the sickness, known medically as ketosis, are not fully understood, most experts agree that it occurs when the brain receives conflicting messages from different parts of the body that respond to motions. The sensory confusion creates dizziness, which activates the brain’s ‘vomiting control center,’ and the result of this is probably not going to be one of the more pleasant memories from your vacation.

Symptoms
The most common symptoms of motion sickness are; a general feeling of illness, nausea, vomiting, headache and sweating. Symptoms tend to go away after the movement stops.

Different medicines thrown on top of a table.

How Is It Treated?
If you want to prepare for motion sickness, you may want to put some pharmaceuticals on your packing list. Some of these medications require a prescription and should be taken before traveling for best results. The best medicines for reduction of nausea and vomiting are:

  • Scopolamine
    This comes in the form of a patch which can be placed behind the ear
  • Antiemetic
    This reduces nausea. Examples include ondansetron, or Zofran, and prochlorperazine, or Compazine.
  • Antihistamine
    Some antihistamines, like dimenhydrinate, Dramamine, and meclizine, Antivert or Bonine, relieve nausea, but they also may cause drowsiness.

If You Find Yourself in The Throes of Motion Sickness, You May Want To Try The Following:

  • Eat some dry soda crackers
  • Drink something clear and fizzy, like ginger ale
  • Get some fresh air
  • Lie down, or try not to move your head

Avoiding Motion System
Of course prevention is the best medication. If you know you are prone to motion sickness:

  • Keep your head as still as possible
  • Avoid alcohol and heavy meals before traveling
  • Avoid eating and drinking during short trips
  • Avoid strong smells and spicy foods

Couple in a car.

In The Car
If motion sickness hits you while you’re in a car, try and sit in the front seat and avoid reading and watching TV.

In A Plane
If the plane travel triggers your motion sickness, eat small easy to digest meals before and during a long flight to reduce nausea and vomiting and request a seat near the wings.

On A Ship
Sea sickness is the most common form of seasickness. If you’re planning sea travel, your best strategy is to book a cabin near the middle of the ship near the waterline. Try and sit in the middle of the boat, get as much fresh air as possible and keep your eyes focussed on a fixed point on the horizon.

Other Methods
You may hear of the efficacy of taking powdered ginger capsules or wearing acupressure wristbands to prevent motion sickness. Although they are safe to use, there is no evidence of their helpfulness.

Do you suffer motion sickness? Let us know what you do to prevent it from turning your dream destination into a travel nightmare.

Woman checking pills

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.

Woman with the flu

Prepping For Cold and Flu Season

During her highly anticipated Diamond Tour, Rihanna contracted laryngitis and a cold after a Buffalo, New York appearance and was forced to cancel her upcoming shows. And little wonder! How can a girl from the tropical Barbados possibly be prepared for the unforgiving climate of Buffalo, New York?

And, while most people would agree that colds are inconvenient, uncomfortable, and unnerving when Rihanna contracts laryngitis, it is nothing short of a national disaster; after all, what is Rhi-Rhi without her voice? Not to mention all these gorgeous outfits hanging unworn in the closet. How sad! If only Rhi-Rhi had been prepped for cold and flu season!

Now, maybe your cold or flu is not likely to garner the attention on social media, but it is still distressing and does not come without costs. Here are some things you can do to avoid getting sick this year.

Load Up the Medicine Cabinet
The next time you’re at the market make sure to add a few extra items to your list. You’ll want to stock up on decongestants, cough medicines, antihistamines, pain relief meds, and vitamins. You may not need them now, but better safe than sorry.

Make Sure you Have the Right Equipment
Besides medicine, it’s always a food idea to have a thermometer with fresh batteries, a humidifier, hand sanitizer, tissues, and anti bacterial soap. Remember, you won’t feel like going out and getting them when your sick.

Bring On the Chicken Soup
Make sure your kitchen is ready to handle your cold. Make sure you have lots of fluids, including water and herbal tea, and Vitamin C loaded fruit juices. Also, be prepared with heat and serve comfort foods that can soothe sore throats and keep away chills.

Get a Flu Shot
Flus are extremely contagious and, unlike colds, can spread a day before its symptoms how up. The flu vaccine is the best way to protect yourself from the common flu strains and is updated each year according to predictions about the coming season.

Wash Your Hands Properly
Begin with anti-bacterial soap and warm water. Spend about 20 seconds lathering up, concentration on jewelry and fingernails. To track the time, you can sing “Happy Birthday” twice, but, be warned, the woman next to you may turn around and say,”How did you know?” Rinse and dry hands and use a disposable towel when touching the faucet.

Keep Household Surfaces Clean
Yes, even your house is not a safe haven. Cold and flu viruses can thrive on surfaces outside the body form between a few seconds to a few days. Clean surfaces with products containing alcohol, sodium hypochlorite, hydrogen peroxide, citric acid or bleach. There should be an EPA number on the label informing you whether or not the products meets the guidelines for disinfectants.

Have you done enough this season to fight off the cold and flu? What do you think? Did you get your flu shot this year? Let us know and tell us what you do to keep the germs away. Inquiring minds want to know.

Human neuron

The Cell Transformation that Could Transform Medicine

The treatment and management of diseases and conditions is one of the most heavily studied areas of science. New discoveries are made every day, some of which have the power to transform medical practices. A recent study by molecular and cellular biologists indicates that the way in which personalized medicine is practiced may truly transform. Scientists have been able to use gene insertion to transform one type of cell into another type of cell. Adding genes into the original cells is a highly intricate process that involves a significant time investment. Additionally, when using gene insertion to transform cells, there is the possibility one of the genes meant for insertion could end up on a chromosome and activate a cancer-causing gene. New studies published online by Cell Stem Cell states that scientists have successfully transformed skin cells into neurons without the use of gene insertion.

The Study
The studies published online by Cell Stem Cell assert that scientists have been able to transform one type of cell into another type of cell with a less invasive and time consuming process. The new transforming technique involves the addition of a specific set of chemicals to the cells. Gang Pei, a co-author of one of the studies and a biochemist at the Shanghai Institutes for Biological Sciences in China explains that the crucial element in this new way of transforming cells is the use of small molecule chemicals. These small molecule chemicals go into the cell and enter the nucleus of the cell, the part that contains DNA. From here, the small molecule chemicals are able to alter the activity of a gene. Pei, and the team he led, spent enormous amounts of time researching the exact chemical concoction that can transform cells; in the study they transformed skin cells into neurons. The specific group of chemicals used by Pei and his team are labeled VCRFSGY and these chemicals work in stages. VCRF, the first four chemicals, begin the process by altering physical traits on a gene known as Tuj1 (a gene that is specifically active in neurons). Without the last three chemicals, the altered cell exists in an ambiguous state being neither a skin cell nor a neuron. The SGY chemicals amplify the neurological development that VCRF initiated which results in cells that looked, and acted like, neurons.In a second study, researchers in China were able to achieve the same results in mice using different chemicals.

Why it Matters
With two separate studies, and two sets of chemicals, producing the same results, molecular and cell biologists believe that this process could compete with gene insertion in order to reprogram and transform cells. They believe that the process of using small molecule chemicals will especially benefit the field of personalized medicine. These study is exciting because with these processes, a patient’s own cells can be used to treat illnesses and other conditions. Pei’s team was able to transform skin cells from an Alzheimer’s patient into neurons that exhibited markers of Alzheimer’s disease. With this process, researchers would be able to safely and accurately research the disease and perform drug tests on the transformed cells without endangering the patient.

These studies indicate that medical research and development continues to reach new and exciting heights constantly, which provides the scientific community with hope that disease study will advance to the point where cures are possible. These studies are just the beginning of the powers of cell-transforming technology and only time will tell what will be possible in the future.