Kids and Research

Kathy Hann — Sat, 22 May 2010 17:26:37 +0000

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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Will lower drug prices jeopardize drug research?

Kathy Hann — Tue, 08 Dec 2009 18:08:36 +0000

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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Kids and Research

Will lower drug prices jeopardize drug research?