Herbal supplements should be regulated as prescription drugs - Essay Example

? Dis about the Regulation of Herbal Supplements The dis about the need of regulating herbal supplements is getting momentum along with the increasing and preferred use of the herbal products by the people. This paper put forwards the argument about the regulation of the herbal supplements like prescribe drugs. It argues that herbal supplements are the pure natural products having lots of benefits for the human health but at the same time there are possibilities of side effects of herbal supplements as well. Physicians and other healthcare experts have identified several potential harms of using herbal supplements without proper guidance and instructions that indicate the need of regulating herbal supplements like prescription drugs. This paper also stresses upon the need of providing more awareness to the people regarding the possible harmful effects of herbal supplements so that they could use these supplements only when suggested by their physicians or other healthcare experts. Discourse about the Regulation of Herbal Supplements An athlete came in the emergency of the hospital. He reported intense pain in his liver. The medical staff conducted all the tests and examinations to diagnose the root of the problem and it was unveiled from the test reports and examination that his lever was failed and was not working properly. The doctor diagnosed that the liver was failed mainly due to the use of illicit steroid. When asked from the athlete, he informed that has been using performance supplements that were considered legal with no side effects. However, his health conditions revealed that the use of the herbal supplement has destroyed his liver. He was admitted for treatment in the hospital and the doctor strictly instructed him to stop the use of the self-selected supplement. Also a Georgia woman took a memory booster herbal supplement and developed diarrhea, joint pain, hair loss and lung problem. These examples show the potential effects of herbal supplements upon the health of the human beings. Herbal supplements are the natural products that are made from the plant extracts. These could be used for the treatment and prevention of wide array of diseases and health problems. The trend of using the herbal medicines and supplements has considerably increased over the last few decades (Dennis 2009). People commonly take the herbal supplements as a measure of self-medication in case of any minor illness and health problem. This is because the herbal products have proved their significance and effectiveness in dealing with the health issues without causing negative side effects in the human body. As the interest of the people in the herbal medicines is growing, the concerns of the common people and health scientists are also increasing in identifying the potential side effects of the herbal supplements upon the human health. The evolving debate about the regulation of herbal drugs has also got momentum as the medical practitioners and health science experts are convincingly pointing towards the potential negative and adverse effects of herbal medicines and need to regulate them like other prescribed drugs. It is now widely demanded by the physicians and other healthcare experts that the herbal supplements should also be regulated like the other prescribed rungs. Currently, the United States Food and Drug Administration (FDA) considers the herbal supplements as food due to which these are not subjected to same regulations like the other prescribed drugs (Aronson, 2009). Herbal supplements are defined by the Dietary Supplements Health and Education Act of 1994 (DSHEA) as products (other than tobacco) intended to supplement the diet containing one or more of the following: vitamins, minerals, herbs or other botanicals, amino acids, or any combination of the above ingredients. Herbal supplements could be taken in form of tablet, capsule, powder, soft gel, cap, or liquid. They are not supposed to be used as conventional food or as a sole item of a meal or diet but these are just dietary supplement taken along with the regular diet (United States Government Accountability Office, 2009). Food and Drug Administration (FDA) regulates herbal supplements under foods not drug as amended by DSHEA. Herbal supplements contain great health value. These natural products could significantly improve the health quality. People all over the world and in United Stated are increasing turning towards the herbal supplements as self-medication tool without knowing much about their potential negative impacts upon the human health. There is lack of awareness among people about harmful effects of herbal supplements and currently there are not regulated by the FDA. The paper stresses upon the importance and critical need of regulating the herbal medicines and argues that there is essential need of regulating the herbal supplements like the prescribed drugs because these products could also negatively react upon the human body about which people are widely unaware. The herbal supplements are currently regulated by FDA as dietary supplement and they only comply with the FDA standards meant for the food regulation. Although the herbal supplements are not simply food but require to be carefully scrutinised like other drugs to limit the possibilities of their misuse and harmful effects upon the health of the people. Herbal products are mostly self-selected because the physicians generally do not prescribe the herbal products and the people start the use of these medicines at their own without knowing much about their potential negative impacts upon their health. There is growing body of evidences ascertaining the benefits of herbal supplement for the health however, at the same time there is a school of thought arguing about the need of regulating the herbal supplements while stressing upon the potential harmful effects of herbal supplements. As a result of their arguments and concerns, it is now commonly demanded by the general public and health specialists that FDA should also consider the regulation of the herbal supplements because these products could also cause some harmful side effects to the health of the people (Dennis, 2009). Herbal supplements should be regulated as prescription drugs because they can several cause side effects to the human body. FDA estimates that almost 50,000 safety problems a year are related to herbal or dietary supplements use. It means that millions of Americans are taking supplements every day without knowing that these are harmful for their health and could lead them towards deaths and life threating health problems. A recent study shows that 12 widely used supplements ingredients including Comfrey, kava and bitter orange are linked to serious health risks like cardiovascular, liver and kidney problems (Mister, 2010a). In 2002, a patient who had liver transplant died after the hepatic failure due to the use of Kava containing products (Aronson, 2009). Herbal supplements have also caused several deaths. In 2008, FDA received 596 mandatory report of adverse event such as cardiac and respiratory disorders among the users of the herbal supplements. Out of the 596 adverse events, 9 deaths were reported by the United States Government Accountability Office (USGAO, 2009).in 2009 also 2,500 cases of herbal supplement side effects were reported and 79 deaths are also caused by the use of different herbal supplements. Some dietary supplements like the GMP herbal weight loss supplement Pai You Guo was also recalled in 2008 because it was found that the supplement contains sibutramine that increases the blood pressure and heart beat rate. It can also cause serious health problems for consumers with cardiovascular illness history (More dietary supplements, 2009). The herbal supplements required to be carefully regulated because some herbal supplements can interact with the consumer prescribe drugs and cause death or serious health problems among the users. According to Izzo and Ernst (2009), Ginkgo interacts with aspirin and ibuprofen and warfarin will decrease the plasma concentration of omeprazole and ritonavir (Izzo and Ernst, 2009). Other supplements including garlic, ginseng and vitamin K can also cause bleeding or clotting problems if taken with certain other medications or before surgery. In addition, these supplements could also promote depression and affect the metabolism of more than half of all prescription drugs and can also undermine the birth control pills (Marchione, 2009). Regulation of the herbal supplements having the potential to cause health problems to innocent consumers will not only save the citizens’ lives but could also reduce the unwanted health problems resulting from the herbal supplements side effects. The regulation will allow FDA to identify and react upon the concerns and questions about the safety of herbal supplements (USGAO, 2009). FDA would have more control over the herbal supplements industrial and it would be able to assure the benefits of herbal supplements before they get into the market. The regulation could also increases consumers’ confidence upon the safety of herbal supplements and FDA. It is very important that the proposed food safety bill should ask the supplements manufacture to register annually with FDA and permit FDA to recall potentially dangerous supplements. The side effects of herbal supplements are commonly reported however, it doesn’t imply that all the herbal supplements cause harmful side effects. The herbal supplements like omega-3 fat and fish oil and coenzyme (CoQ10) have proved to be safe and beneficial for the human health. The fish oil is very useful for treating allergies, asthma and eczema and CoQ10 has the potential to protect and strengthen the heart and lower blood pressure (Mindell and Hopkins, 2009). A California pediatrician Dr. Claudia Morris shares her experience that her son partially recovered from apraxia after she gave him herbal supplements. According to Dr. Morris verbal apraxia also called apraxia of speech is a neurologically based disorder in which a person has difficulty speaking correctly and consistently. She pointed out towards several important benefits of herbal supplements and informs that the children with verbal apraxia showed dramatic improvement in their speech after taking omega-3 and vitamin E (Shelton, 2010). While it could be said that not all herbal supplements have side effects, it still remains a facts that herbal supplements are causes behind some health problems and deaths in America. Until and unless these supplements fall under the same umbrella as prescription drugs they are harmful to consumers. Through proper regulation of these supplements FDA can keep track of benefits and harmful effects of herbal supplements and several health problems and deaths could be prevented. The American Journal of pharmaceutical education (2009) reported that only 15% out 50 % of Americans used herbal supplements that were guided by a health professional whereas more than $4 billion supplements are purchased without the supervision of a doctor and over 50% of these purchases are made either at supermarket, GNC, or Vitamin Shoppe. 70% of patients who use herbals supplements do not report it to their primary care doctor (Bonafede, et al, 2009). The opponents of herbal supplements regulations also argue that even though herbal supplements are regulated as foods instead of drugs there is still no need to regulate herbal supplements as drugs because they are not drugs but natural products that offer wide range of benefit to the health of human beings. These natural products possess great health value and sensible use of these supplements could not cause any harmful effects to health. Furthermore, there is a growing demand of regulation of herbal supplements because the health professionals generally lack proper training and skills to assess the safety and effectiveness of the herbal supplements and they oppose their usage and stress upon their regulation (Aronson, 2009). The situation demands that FDA needs to provide consumers with helpful tips to identify false and misleading claims. Some supplements claim they can cure diseases like cancer, which manufacturers are not permitted label on herbal products. But the fact is that the significance of herbal supplements cannot be denied because they are very beneficial to human health. Dr. Wolff mentioned in an interview that the supplements like flax seed oil, ginger, green Tea and fish oil taken on the daily basic help to live healthy and extension life (Voker, 2011). He also stated that the “herbal supplements should not be regulated as pharmaceuticals but instead there is need to increase research on both the positive and negative effects of the herbs.  If the research will prove the danger then regulation or banning should occur” (Voker, 2011). The FDA is the responsible body that needs to provide consumers with helpful tips to identify false and misleading claims. Some supplements label claim they can cure diseases like cancer but the consumers should also watch carefully for any symptoms that start after they take a new supplement. There are many consumers who are not doing the right things to protect their health so the best thing for Americans is to regulate herbal supplement as prescription drugs. Changing the law will help the healthcare professionals to keep track of their patient’s intakes of drugs and health history. Contrary to this argument physicians and other healthcare experts may lack proper training but at the same time herbal supplements are still effective and the manufactures are not compelling with FDA to save the lives of innocent citizens. FDA do cited warring signs in its public- health advisory on the products that may contain steroids could cause nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, yellow corneas and skin, and discoloured urine (Wilde, 2009). In the same way, the warning signs should be cited on the herbal supplements to make people aware of the potential side effects of these supplements. The consumers must be well aware and informed about the fact that the herbs could be harmful as they can even change consumer’s skin color. For example, an Oklahoma woman bought an herbal treatment for Lyme disease that turned her skin blue (High risk of supplements, 2010). Health professionals are just concerns about their patients because many patients do not tell their primary doctors that they are taking some kind of supplements. Consumers are lacking awareness about the side effects herbal supplements. The regulation of herbal supplements is not a simple task but involves several complications. Changing the law will harm many Americans because it will limit access to consumers by driving up costs and delaying the supplement’s entry into the marketplace (Shelton, 2010). However, the benefits of regulating the herbal supplements are much important as compared with these complications The new law will harm elderly Americans that do not have insurance and money to buy their prescribe drugs and they usually turn to herbal supplements because they are cheap then other prescribed drugs. For example, the drugs Celebrex used to treat arthritis costs more than $4 per day while a ginger supplements that could also be used for inflammation cost about $0.38 per day (Keiley and Bloyd, 2007). Most of the prescribed drugs are very expensive causing many Americans to prefer the use of herbal supplements. As a result lots of patients will their doses of their prescribed drugs and use the herbal supplements. It was reported in 2001 that nearly one in four senior citizens skip doses or leave the prescriptions unfilled (Keiley and Bloyd, 2007). It has to be clearly understood that changing the law will not harm many Americans. Instead it will improve their life and health quality and will help them save money. A recent study shows that every year Americans spend millions of dollars on supplements for self-treatment of diseases they diagnosed by themselves. FDA received about 596 cases every year that involve herbals supplements use (USGAO, 2009). It is true that it would take long time for herbal supplements to reache the markets for consumers to purchase but it is for the best of the consumers. The scientific studies will be involved in the process to assure that every herb is safe to use. Right now there is no scientific study showing that the herbal or dietary supplements are free of side effects. The change in law will give FDA more power over the manufactures process of supplements. The manufactures would also be required to provide information about their products such as product name and ingredients to the FDA. At the same time, FDA will have the authority to require herbal supplements to be approved for safety and efficacy before they enter the market (USGAO, 2009). FDA issued their first advisory on the issue before 10 years. Since then FDA has not banned any other dietary or herbal supplements (USGAO, 2009). Right now, the FDA do not have the ability to require supplements industries to report moderate or mild adverse events such as headaches, or gastrointestinal distress except in a serious events says the United States Governments Accountability Office (USGAO, 2009), which make it even worse. In the meantime the FDA should do what they can to educate consumers about safety. They should provide tips on the websites like nih.com, NCCAM.com, and FDA.com that include the information about identifying the misleading claims like products is natural, safe, quick and can cure or treat a disease. The significance of herbal supplements could not be denied because these are among the oldest healthcare tool of the human beings and several modern day medicines are based upon them. They offer wide array of benefits to the health of the human beings and contain great medical value but still the need of regulating them is very important to preserve the human health from their possible negative effects (Dennis 2009). The regulation of herbal supplements as prescription drugs is necessary and immediate actions should be taken by the authorities to assure the regulation of the herbal supplements like the prescribed drugs. References Aronson, J. K. ( Ed.) (2009). Meyler’s side effects of herbal medicines. San Diego, CA: Elsevier. Awang V. C. D. (2009). Tyler’s herbs of choice: The therapeutic use of phytomedicinals, (3rd ed). Boca Raton, FL: CRC Press. Bonafede, Caron, and Zeolla. (2009). Evidence- based elective on dietary supplements. American Journal of Pharmaceutical Education, 73(5), 80. Retrieved from http://search.proquest.com.southuniversity.libproxy.edmc.edu./docview/211315080?accou tid=87314 Dennis V.C. Awang (2009). Tyler's Herbs of Choice the therapeutic use of phytomedicinals, USA: CRC Press, Taylor & Francis Group High risk of supplements gets exposed-yet again. (2010). USA Today. A. 10. Retrieved from http://sks.sirs.com.southuniversity.libproxy.edmc.edu/cgi-bin/hst-clean-copy?id=SSTHPR Izzo, A.A., & Ernst, E. (2009, February). Interactions between herbal medicines and prescribed drugs: An updated systematic review. Journal of Medical Science, pharmacy and Pharmacology, 69(13), 1777-1798. doi:10.2165/11317010-000000000-00000 Keiley, L., & Bloyd, S. (2007). What you should know about drug vs. herbs. Mother earth, (219), and 101+. Retrieved from http://sks.sirs.com/cgi-bin/hst-clean-copy?=SSTHCOLUM-05308&type=ART&artno Marchione, M. (2009). Test show many supplements have quality problems. Gainesville Times, n.d. Retrieved from http://sks.sirs.com/cgi/hst-clean-copy?id=SSTHCOLUMB-0-6978&type=ART&artno= Mindell, E. L., & Hopkins, V. (2009). Drugs for the heart disease and their natural alternative. Prescription Alternatives: Hundreds of safe, natural, prescriptions free remedies to restore & maintain your health, (4th ed). New York, NY: McGraw Hill. Mister, S. (2010a). Risk is grossly overstated. USA Today, pp. A.1. Retrieved from http://sks.sirs.com.southuniversity.libproxy.edmc.edu/cgi-bin/hst-article-display?id=SSTHPROXY-0-7631&artno=0000305929&type=ART Mister, S. (2010b). Existing law works. USA Today, p. A. 10. Retrieved from http://sks.sirs.com.southuniversity.libproxy.edmc.edu/cgi-bin/hst-article-display?id=SSTHPROXY-0-7631&artno=0000304019&type=ART More dietary supplements recalled (2009). Reactions Weekly. 1279. P.2. Retrieved from http://search.proquest.com/docprintview/375431848/12F268D1FDC853C/15?accountid Shelton, D. L. (2010). A promise of help, but does it delivers? Chicago Tribune, 1. Retrieved from http://www.sirs.com United States Government Accountability Office (2009). FDA should take further actions to improve oversight and consumer understanding. GAO-09-250 Dietary supplements. Washington, DC. Wilde, M. A., (2009). What’s really in supplements? Wall Street Journal. B7. Retrieved from http://sks.sirs.com.southuniversity.libproxy.edmc.educ/cgi-bin/hst-article-didplay?id= Read More