The R&D Tax Credit Aspects of Pediatric Hypertension



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Pediatric-Hypertension
        Often thought of as a disease of the middle-aged and elderly, hypertension is increasingly observed amongst children. The present article will discuss the many challenges surrounding pediatric high blood pressure as well as the innovative efforts aimed at developing more effective, child-specific treatments. It will also present the R&D tax credit opportunity available to support companies engaged in overcoming this growing yet often neglected health problem.


The R&D Tax Credit

        Enacted in 1981, the Federal Research and Development (R&D) Tax Credit allows a credit of up to 13 percent of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

  • New or improved products, processes, or software
  • Technological in nature
  • Elimination of uncertainty
  • Process of experimentation

        Eligible costs include employee wages, cost of supplies, cost of testing, contract research expenses, and costs associated with developing a patent.  On December 18, 2015, President Obama signed the bill making the R&D Tax Credit permanent.  Beginning in 2016, the R&D credit can be used to offset Alternative Minimum tax and startup businesses can utilize the credit against payroll taxes.


High Blood Pressure in the U.S.

        Hypertension is a condition in which the force of the blood against the blood vessels is higher than it should be. This pressure is determined by both the amount of blood pumped and the levels of resistance to blood flow.

        There two main types of high blood pressure: 1) essential hypertension, also known as primary or idiopathic hypertension, which has no identifiable cause; and 2) secondary hypertension, which is caused by other medical conditions, such as abnormalities in the arteries that supply blood to the kidneys, adrenal gland disorders, sleep apnea, thyroid and parathyroid problems, amongst others. In 95 percent of high blood pressure cases no apparent cause can be found.  

        In the U.S., about 1 in every 3 adults, or nearly 70 million people have hypertension and are, therefore, at greater risk for heart diseases and stroke, two of the leading causes of death in the country, as well as end-stage kidney disease.
    
        Also referred to as the “silent killer” hypertension often goes unnoticed, due to the absence of symptoms. According to the Centers for Disease Control and Prevention, only 52 percent of the American adults who have high blood pressure have their condition under control.
Hypertension has an annual economic impact of $46 billion in the U.S., which includes healthcare services, medications, and missed days of work. In 2013, the condition was listed as the primary or contributing cause to over 360,000 American deaths, or almost 1,000 per day.  


Pediatric Hypertension

        Even though high blood pressure is more commonly observed in adults, it does affect children, which can suffer from both essential and secondary hypertension. According to the International Pediatric Hypertension Association (IPHA), as many as 5 percent of children and adolescents may have essential hypertension.

        The recent rise of high blood pressure rates amongst children has been linked to the growing prevalence of childhood obesity. However, even newborn babies can suffer from hypertension, which is often caused by the exposure to illegal drugs or inherited predispositions.

        There are many challenges and unanswered questions surrounding pediatric hypertension. However, it is already known that children who have high blood pressure tend to become hypertensive adults. It has also been observed that children with high blood pressure tend to suffer from other medical conditions, including obesity, high blood lipids, and diabetes.  

        Difficulties in diagnosing and monitoring pediatric hypertension include the absence of a single cut-off above which a child’s blood pressure is considered high. Instead, diagnosis is conceived in relative terms – if a patient’s blood pressure is higher than 95 percent of children of the same gender, age, and height he is considered hypertensive.  

        The unreliability of clinic measures, which fail to provide a comprehensive assessment of different 24-hour blood pressure patterns, is also a challenge to detecting childhood hypertension. It frequently overlooks important aspects such as white coat, nocturnal, diurnal, high-amplitude, and stress-induced hypertension.


Recent Findings

        Pediatric high blood pressure has been recently linked to rapid weight gain in infants and preschoolers. In a study that tracked the weight and height of more than nine hundred babies up to age four, researchers from the Brigham and Women’s Hospital in Boston found that those who underwent unusual surges in body mass index before 6 months and between the ages of 2 and 3 had higher blood pressure in mid-childhood then the ones who experienced steadier growth.

        Though further research would be necessary to assess direct causality, the findings support the importance of a healthy diet, particularly breastfeeding, which is linked to a more linear weight gain than formula feeding.  

        Another recent study unveiled a connection between allergies, such as asthma and hay fever, and a greater risk for high blood pressure and high cholesterol in children. Researchers from Northwestern University Feinberg School of Medicine discovered that the cardiovascular risk factors of children who suffer from these allergic diseases are about twice the rate of healthy kids.

        This finding should encourage parents and doctors to perform regular screenings of patients with severe allergic conditions. In the words of Dr. Jonathan Silverberg, an associate professor of dermatology at Northwestern University:

        “Given how common these allergic diseases are in childhood, it suggests we need to screen these children more aggressively to make sure we are not missing high cholesterol and high blood pressure. (…) There may be an opportunity to modify their lifestyles and turn this risk around."  


Child-Specific Medication

        Most guidelines for treatment of pediatric hypertension recommend lifestyle modifications, such as weight reduction, regular physical activity, and healthy habits. However, some cases require the use of medications, particularly in children with symptomatic or secondary hypertension, target organ damage, diabetes, or persistent hypertension.

        The absence of comprehensive clinical trials assessing the patient-oriented, long-term outcomes of antihypertensive medications in children remains a major challenge when it comes to determining the best course of treatment. Most recommendations extrapolate from adult studies, even though age differences may influence how people respond to therapy.

        In this scenario, there is an indisputable necessity of innovative antihypertensive drugs, specially tailored for the age, weight, and physical condition of the child taking them. This advancement is key to promoting safer and more effective treatments as well as to avoiding harmful overdosing, which can lead to significant health complications.

        Examples of innovation in this domain include the collaboration between the Institute for Pediatric Innovation, Beckloff Associates, Children’s Mercy Hospital, Silvergate Pharmaceuticals, and the University of Kansas, which led to the development of Epaned, the first oral medicine approved by the U.S. Food and Drug Administration for use in children with high blood pressure. Introduced to the market in 2013, the flavored liquid medicine is specifically designed for small children aged one month and older. In addition to providing accurate dosing levels for children, Epaned is easy to swallow and can, thus, improve adherence to treatment.  

        The development of safe and effective medicines for children is an often-neglected area of research. The World Health Organization stresses the importance of innovative efforts that take into account the fact that “…children metabolize medicines differently from adults [and] therefore need different dosage forms. (…)[also] child-specific medicines need to be in a format that is palatable to children.”

        The growing prevalence of pediatric high blood pressure makes this especially true for antihypertensive drugs.  


Big Data and Hypertension Research

        Technological innovations can open the way for more effective diagnosis, monitoring, and treatment of pediatric hypertension. This is particularly true for big data analytics and the use of electronic health record (HER) information, which allow for larger and more comprehensive studies that can potentially shed light on previously unknown connections.  

        In 2015, researchers at the Regenstrief Institute and Indiana University analyzed big data from EHRs between 2004 and 2012 and discovered that the combination of triamterene, a drug prescribed to conserve potassium in the blood, and hydrochlorothiazide, a common diuretic, can help lower the blood pressure in hypertensive patients. According to the first author, Wanzhu Tu, Ph.D.: “This study is a perfect example of how we can learn about the previously unknown therapeutic effects of drugs from big data [and] answer questions that may otherwise be unanswerable.”

        Access to big data is particularly valuable for pediatric hypertension. Published in 2004, the National Heart, Lung, and Blood Institute’s Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children underlines the importance of developing a large national database on blood pressure levels throughout childhood as a means to improve the ability to detect hypertension. Over a decade later, the emergence of EHRs and big data analytics promises to take this ability to an unprecedented level.


Hypertension Self-Management Applications

        Mobile technology is empowering hypertensive patients to manage their conditions and allowing them to establish more effective communication with their physicians. The number of hypertension self-management apps has recently surged along with their usage.

        According to the website iMedical Apps, common features include: 1) a medication reminder function, which can contribute to greater adherence to medical therapy; 2) a measurement reminder function, which encourages users to perform regular home blood pressure monitoring; 3) self-care messages, designed to respond to self-monitoring information and educate users as to how they could improve their lifestyle; and 4) automated sharing with the user’s physician.  

        Some apps also incorporate additional user information, such as patient’s weight, diet, physical activities, and medication. By analyzing this data, they help identify patterns in blood pressure readings and their potential relation to changes in any one of these aspects.

        Smart devices can make hypertension management even easier.   Connected blood pressure monitors automatically feed data into mobile applications that use it as basis for the analysis of trends and patterns. Examples include QardioArm, a clinically validated, wireless monitor that measures systolic and diastolic blood pressure and detects irregular heartbeat. Created by San Francisco, California-based Qardio, Inc., the device is connected to a mobile application that stores data and use additional information, such as location, to provide insights on potential lifestyle choices that could affect the user’s condition.  

        Hypertension self-management applications and smart measuring devices can be particularly helpful for parents willing to track their children’s blood pressure. The creation of child-friendly applications for both monitoring and educational purposes is an emerging trend. Researchers at the University of California, Los Angeles and the University of Southern California, for instance, have recently been awarded $6 million by the National Institute of Biomedical Imaging and Bioengineering to develop a mobile application for predicting asthma attacks in children.  Though the creation of an easy-to-use interface for children may be challenging, this sort of effort can greatly contribute to managing a variety of pediatric conditions.


Conclusion

        Often associated with adult life, hypertension in children has often been overlooked. The indisputable growth in prevalence, however, has shed light on the importance of creating child-specific treatments and monitoring tools. Companies investing in new drugs and technology targeted at pediatric high blood pressure should take advantage of R&D tax credits to increase their chances of success.

Article Citation List

   


Authors

Charles R Goulding Attorney/CPA, is the President of R&D Tax Savers.

Andressa Bonafé is a Tax Analyst with R&D Tax Savers.


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