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Kids and Research

As a parent have you ever thought about the medicines that you give your children?  Have they been proven as safe and effective?  In reality, only about a quarter of all approved drugs marketed in the United States have had clinical trials performed involving pediatric patients.  Doses for children are often merely adjusted for their smaller weight, but there are many other differences in children that can affect how drugs act in the body. The lack of pediatric testing and labeling can place children at risk of under- or over-dosing, and the lack of age-appropriate formulations, such as liquids or chewable tablets, can result in improper administration of drugs.

In the past ten years, however, studies have increased; and they are reporting important data.  For instance, Ibuprofen which is commonly used to reduce fever and swelling had no dosing information for children less than 2 years of age, but studies in thousands of infants established a safe and effective dose in infants and children from 6 months to 2 years.

Studies with a marketed sedative, led to a new oral formulation for use in infants and children. In addition, the study results showed that this drug has a high risk for an adverse event in children with congenital heart disease and pulmonary hypertension.  In the controlled setting offered by clinical research, it is possible to identify these side effects before they become life-threatening to the participants and that knowledge is applied for future labeling.

It may seem like a scary proposition to put your child on an “investigational medication” but most of the studies that are being done are testing medications currently approved at adult doses – and being given to children anyway!

Many physicians agree that the care received during a clinical study is higher than the normal standard of care because data is being collected that requires more extensive studies and more frequent visits.  Of course, that translates to a little extra time and effort for the parents and the children, but your sacrifice could save a child’s life.

If your child has a serious condition, you may be more willing to consider a study in hopes of finding a cure.  Even a healthy child can have an emergency or develop a disease requiring medication.  Knowing that the proper measures had been taken to determine the safety and effectiveness in children would be comforting.

If you decide to consider taking part in a research study, always remember that you are a volunteer.  Make sure that all your questions are answered before you agree to participate.  Several sources on the internet tell you exactly what to ask;  if you don’t feel comfortable, realize that you may withdraw at any time.

If you participate in a study, share with your child the importance of compliance and make them proud of the responsibility that they have taken on.  Most importantly,  let them know how proud you are that they are helping children in the future.  Personally, I think it calls for ice cream!

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High Fructose Corn Syrup to Blame?

I spend hours a week exercising and trying to trick my not so young body into returning to the body of a few decades ago.  It’s not like I’m asking for the body of college years.  That would be a miracle and a whole different blog topic.

As a researcher and scientist I read a lot of  studies.  As someone who also love s to garden and cook and someone who loves to eat I also read articles about healthy eating and raising my own vegetables.  I’ve seen that reasonable eating can reduce my body weight.

I’ve also seen an apparent link between genetics and the health issues that I am trying to avoid like high cholesterol and high blood pressure.  After all, my husband and I both eat the same things for the most part but his cholesterol is 50 points less than mine.  Granted I am not taking into account ratio of good to bad cholesterol which is important but just to keep it simple I’m talking about total cholesterol.  On the other hand he has high blood pressure and I have low blood pressure.

His idea of exercise is watching me do P90X.  He does drink wine more regularly than I and doesn’t skimp when it comes to dipping that whole grain bread in olive oil but he just doesn’t seem to struggle with those few extra pounds the way that I do…. and he is a decade ahead of me.

So today I stumbled across an article that I saved to read “some day” – now I remember why I put it aside for some day.  The article is about the link between soft drinks and weight gain.  Now we could be on to something.  One major difference in our diets is my addiction to the soda in the red can. (gasp)  I do have 20 ounces a day of it.  I occasionally try to quit and I have been successful for brief periods of time- usually until a migraine comes along and I fall off the wagon.

Basically the article is looking at the studies that have been published relating the link in soda consumption to the obesity problem in America.  I know that the acid in sodas in not good for me.  It blocks the absorption of calcium which lowers bone mass.  Luckily my bones so far are healthy although age and hormones, another topic for later, may start taking a toll on that.  The article states that there aren’t enough definitive studies yet to be sure of the link but they do note that the increase in high fructose corn syrup consumption over the last several decades exceeds the increase in intake of any other food or food group. And they do show data that indicates a link between soda consumption and weight gain.

Now I have been trying to cut the HFCS from my diet and I have been amazed at the number of foods that list it high on the label when listing contents.  I’ve managed to eliminate many of the sources of HFCS in my diet just by reading labels and being aware of what I buy.

It is time to take a action on what is now probably the major source of HFCS in my diet as well.  After all, the exercise that I do can add muscles but if that layer of fat is surrounding them it will only hide all my hard work.  Time to start working that other organ in my body and overcome the soft drink habit.

I know that the people at the office don’t want to see this happen.  Not because of the stock prices dropping but they seem to think there is a change in my behavior when we go through this process.  So let’s not tell them.  Anyone want to join me and we can do our own research and see if we can lose some weight, specifically fat, by giving up soft drinks?  It may not be scientific but anecdotal info sometimes leads to good research.  Remember that artificial sweeteners are bad so we have to give them up completely not trade this sin for a different one.  OK, so who’s in?

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Stroke Risk Associated with Migraines and Aura

I recently read an article that links  Migraines with aura as well as the use of estrogen with increased stroke risk. As a scientist I know to use caution with studies that are published without regard to the source of the data, the size of the sample pool or who was funding the data.   I once read a study that Hershey funded that said that chocolate prevented tooth decay.   If you know me at all you can be certain that I am willing to subscribe to prohylactic chocolate  no matter who funded the study.  One more reason for me to eat dark chocolate. Anyway, if the relationship with migraines with aura is linked to increased risk of stroke this is just another opportunity for me to remind all my dear women friends to eat right, exercise regularly and avoid estrogen supplements. Depending on what you read and believe that means we should also be looking at soy products carefully. Perhaps more on that later. Meanwhile, take control of your health!

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Kids and Migraines

Headache is the most frequent neurological symptom and the most common manifestation of pain in children.  Because children are less likely to articulate their problem or seek help their needs are often unmet.  Children who suffer from headaches may have difficulty concentrating on their school work and often experience more missed days and more frequent doctor visits.

As a child, you know when teradactyls flew around, I had headaches almost daily.  They were diagnosed as vision problems and resolved with glasses so that is a great place to start.  As an adult I developed serious migraines with my cycle.  Unfortunately I must have passed that on to my daughter.  In her adolescent years she started with spots in front of her eyes referred to as “aura” followed by nausea and vomiting.  Most children do not experience aura but they will often have a headache preceded by mood changes or withdrawal from activity.

If your child suffers from headaches and complains about sensitivity to light or sound or the headache is accompanied by nausea or vomiting they are probably experiencing migraines.  In one study of over 48,000 children with headache 80% of the primary headaches were migraines.

As a mother we always worry about our children and the concern with headaches in children is often that there is something serious causing it.  The goods news is that the risk of a malignant tumor in pediatric migraine patients is very minimal.  In the study mentioned above the risk of malignant tumor was 0.03% compared to 0.004% in the control group.

Realizing that the pain, although unpleasant, is not life-threatening often allows for healthier coping strategies.  Sleep, darkness, and a quiet room are essential in managing acute migraine and tension-type headache. Scheduled times for meals, bedtime, relaxation, and exercise should be encouraged as well as relaxation techniques.  Sometimes even the focus of a video game can provide relief,

The role of diet in headaches remains controversial. However, if a given food or beverage is associated with headaches, its avoidance has an obvious and significantly positive impact.  Alcohol, drugs, or caffeine may trigger headaches and appropriate lifestyle changes should be encouraged.  If stress or family situations are causing the migraines consider therapy to learn healthy coping mechanisms.

  • Factors that precipitate migraine
    • Common factors
      • Stress/anxiety
      • Menstruation
      • Oral contraceptives
      • Physical exertion/fatigue
      • Lack of sleep (sleep apnea may also be a primary cause of headache)
      • Glare
      • Hunger
      • Foods/beverages with nitrates, glutamate, caffeine, tyramine, salt
    • Less common factors
      • Reading/refractive error
      • Cold foods
      • High altitude
      • Drugs – Nitroglycerin, indomethacin, hydralazine

The bad news is that there is no approved medication for pediatric migraine.  There are studies currently underway that are investigating the affect of new medications on migraines in the pediatric population.  If your child suffers from migraines you know how important this research is.  Look on –line for information about migraine studies in your area.  If you are in the Tampa Bay area go to www.dmiresearch.com for a pediatric migraine study.

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Will lower drug prices jeopardize drug research?

Anyone who has filled a prescription lately was probably astonished at the cost and would agree that we have to find a way to lower prescription drug prices.  So will lower drug prices jeopardize drug research?

Understandably the pharmaceutical companies have to be able to recoup the cost of bringing new drugs to market.  At an average of 10 years and billions of dollars, I suppose that it is tough to fund that on an on-going basis especially if you are expected to do this on lower profits.

Yes, lower drug prices would decrease the available funds to bring drugs to the market.  Many people don’t realize how important the clinical research process is and, while it is not a perfect process, it is designed to protect the American public.  Clinical research provides a method of testing investigational medications in humans under a controlled environment with oversight by Review Boards whose primary purpose is to protect the research volunteer.

While lower drug prices could jeopardize drug research it doesn’t have to stifle it all together.  America will continue to be a leader in development of new medications.  Despite our current economic climate and the challenges that we face we will continue to be a great nation.  While there is great concern about our healthcare system, we will overcome these issues.  It won’t happen quickly, it will certainly be controversial and it will probably be painful;  they don’t make a drug for that.

Every American could make a difference though.  The cost of developing new drugs could be drastically reduced, if the rate of enrollment in clinical studies was increased.  One of the biggest delays in the process is the recruitment of people into studies.  In order to better test the medications, it has to be tested in a statistically significant number of people.  The more volunteers, the better the data.  The quicker the data is collected the lower the cost of the data.

Many people think that people who volunteer for studies are risk takers or that they are only doing it because they are looking for a cure for their own disease but many people volunteer because it will help others.  Many diseases are hereditary so perhaps they are paying forward … even without their knowledge.

Many people are adverse to taking any medications.  While I subscribe to the philosophy that prevention is the best medicine and that anything should be done in moderation I bet that if you check a burn center or a veteran’s hospital you would find any number of people who never thought that they would take medication.  They would now doubt be grateful for the fact that the medication has been tested for safety and effectiveness.

Increasing participation in clinical studies is one way to lower the cost of research resulting in lower drug prices.  So, will lower drug prices jeopardize drug research?   Only if we let it!

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Welcome to DMI Research

Recently we were on a TV special about H1N1.  It was an interactive news program that looked at H1N1 from many perspectives.  Viewers had an opportunity to chat on-line with 4 experts including DMI Research’s Kathy Hann, an expert from the Health Department of Hillsborough County, a school board official and a local physician.  There were  lots of questions and there were 70 people on line during most of the hour long show.

One writer asked about getting the flu vaccine if they have an egg allergy.  Since the vaccine is cultured in eggs people who have egg allergies should not get the vaccine.

Many people had issues with finding the vaccine especially in Pinellas County and a couple of experts were able to help out with availability.  It seems that the health department in Hillsborough County has vaccine available to whoever requests it.

The staff here at DMI Research are conducting a flu treatment study for people who have compromised immune systems and get flu symptoms. Preventing spread of the disease is a key in preventing deaths from complications as well.

Unfortunately the lack of availability of the vaccine left people on high doses of steroids and certain medications for autoimmune disorders as well as organ transplant patients and people undergoing treatment for cancer at risk.

If anyone that you know get symptoms which include a fever check our website to find out how to participate in the study.  H1N1 could be the seasonal flu next year so medications developed this year will help prevent a pandemic next year.

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