1. Has FDA provided ‘sufficient guidance’ to guide development and registration of prescription diet medications? If you agree, provide examples of what you consider ‘sufficient advice’ (including date of publication). I believe the FDA does provide sufficient guidance on the development and registration of prescription diet medications. In 2007, FDA issued draft guidance that clearly defines their expectations to judge effectiveness (weight reduction and maintenance of weight loss after 1 year’s treatment). It also indicates an effective product should provide improvements in blood pressure, lipids, and glycaemia therefore changes in common weight-related comorbidities need factored into clinical trial to assess efficacy. FDA also states it expects to see drug-mediated weight reduction demonstrated to result from a loss of body fat verified through advance screening tools. From a safety perspective, the FDA states the drug should not adversely affect cardiovascular function particularly highlighting cardiac valvulopathy. 2. Has FDA’s grounds for rejecting the NDAs of prescription diet pills in the last 10 years been based on safety/efficacy concerns? In 2010 alone, three drugs reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) have failed to gain approval. EMDAC felt each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had unacceptable safety issues (particularly cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide enough convincing evidence of efficacy and safety to gain approval. EMDAC cite lack of diversity in the phase 3 trial population might result in efficacy of the drug being overstated while potential safety risks understated. Whi... ... middle of paper ... ... FDA. (2010). FDA Briefing Document: NDA 22529 Lorqess (lorcaserin hydrochloride) Tablets, 10 mg. Sponsor: Arena Pharmaceuticals Advisory Committee. Retrieved from http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinlogicalandmetabolicdrugsadvisorycommittee/ucm225631.pdf FDA. (2007). Guidance for Industry. Developing Products for Weight Management. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071612.pdf FDA. (2011).Predictive Safety Testing Consortium (PSTC). Retrieved from http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm231132.html McCallister, E. (2011). BioCentury, Obesity Reset. Retrieved from http://www.biocentury.com/promotions/obesity/next-generation-of-obesity-drugs-unlikely-to-reach-regulators-before-2014.html
...is still research to be done, but for now it is up to the individual to decide if he or she is healthy enough to take these products safely or if it is even worth taking,given the long-term effects.
Obesity has reached epidemic proportions in the United States: more than 20% of adults are clinically obese as defined by a body mass index of 30 kg/m2 or higher, and an additional 30% are ov...
and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicinemedical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Some of the committee's recommendations have been incorporated into drafts of the PDUFA IV bill, which was signed into law in 2007.
Ever since the turn of the twenty first century, the urge to keep a trim, slim figure has become increasingly desired. Pressure from beauty campaigns and other societal influences have drawn a picture of what it means to be beautiful; The picture is a thin, flawless girl sporting a yellow polka dot bikini whose diet consists of strictly salad. As a result, tons of insane, unrealistic dieting plans have emerged, most of which are just fancy and expensive ways of starving yourself. While most of these are highly unethical, a couple have persevered to be quite successful, not only with keeping the number on your scale down, but also with keeping down the numbers of your cholesterol and blood pressure. The Mediterranean Diet, Pescetarianism, and
Losing weight and getting in shape is not a logically simple task. According to research studies it is estimated that 40-50 percent of U.S. households purchase supplements costing Americans over 40 billion dollars per year (SNAC). There are numerous objectives that individuals do not take into consideration like proper diet, training regimens, and even quality sleep. Some understand the importance of combining all elements to have great success while others are searching for the “miracle” pill. In recent years weight loss supplements have exploded into the market of fitness. Some of the supplements like ephedra and yohimbine have been used for weight loss and other purposes. Ephedra is a drug used traditionally in ...
Since 1916, the United States Department of Agriculture (the government agency responsible for all U.S. policy regarding agriculture, food, and farming) has revised their recommendations several times. Unfortunately, money talks and the USDA’s recommendations are based on outdated science and are influenced by people with business interest. Even so, its recommendations are considered almost “holy” by physicians, nutritionists, and dieters, but in reality, they are the root cause of the problem. A single visit to our local public school cafeteria and it will become clear that they do not have the best interests of the children at heart. What they are feeding our innocent children is preposterous. Doctors, the people we trust and expect to be “the experts”, do not know much about the subject of nutrition. A vast majority of medical schools in the U.S. require just 25-30 hours or less of nutrition training, and some do not require at all. So doctors must rely on the ...
As a health care professional it is our position statement that obesity should be considered as a disease. Overweight and obese adults are considered at risk for developing diseases such as type II diabetes, hypertension, high blood cholesterol, coronary heart disease, and certain type of cancers. An average of 300,000 deaths is associated with obesity and the total economic cost of obesity in U.S. was about $ 117 billion in 2000. As health care professionals it is our responsibility to increase public awareness of health consequences of over weight and obesity. Obesity as a disease: Obesity fits all the definitions of ‘disease’, that is, interruption in bodily function.
... some diet supplements out to people who qualify to use a diet supplement. Then why are many diet products still sold over the counter? These fad supplements are still sold over the counter because they are there for people who want to try out these diets and see if they work. Also they are still being sold because their advertisement tricks customers that if they want to lose those extra few pounds that they cannot get rid of. Fad diets do not work for those people. There is a big debate to whether these fad diets should only be prescribed. If these diets were only to be prescribed by doctors to patients with weight problems many of the dietary supplement companies would suffer and jobs would be lost. However, if the diet supplements were to only prescribed by doctors, many people wouldn’t be putting their health at risk with using over the counter diet products.
With the average weight of Americans continuously rising, fad diets seem to appear everywhere, each claiming that their participants will lose weight faster with their healthier option; however, diets are not at all, what they claim to be and without caution, they too will cause health problems. From high-fat, low-calorie, very low-fat, high protein, and everything else in between these trendy diets seem to cause enough confusion that they make sense, even if the dieter has no idea what he will be cutting from his diet or how any of the restrictions and requirements will affect his health overtime. Therefore, if careful research and close monitoring does not take place, diets like The Pritikin Program can be detrimental to a dieter’s health.
The FDA offers programs called clinical trials where a new drug is tested in patients, but the patients are only considered when every other treatment option has been exhausted (Falloon 4). Clinical trials are also selective, as only people of certain ages, sexes, and types or stages of disease with previous treatment are even considered to participate (Inside Clinical Trials 2). This causes almost ninety seven percent of terminally ill patients to be ineligible for a trial (Corieri 3). Also, clinical trials only allow a small amount of people, with only between 20 and 80 people chosen to participate in phase 1 (Inside Clinical Trials 2). With this margin, even ...
Janssens, Cecile. "How FDA and 23andMe Dance Around Evidence That Is Not There." The Huffington Post. TheHuffingtonPost.com, 27 Jan. 2014. Web. 22 Mar. 2014.
Aside from including all of the statistical facts in this section, Satagru sends the loud and clear message that doctors in the U.S. are not particularly educated in nutrition. This is a sad fact that more people should consciously realize. Living in a “magic pill” society is indeed magical until you realize that every pill has an adverse reaction. There isn’t much magical about that.
Every day people are becoming more and more concerned with their health and their appearance. Thanks to scientific research there are many remedies to improve the human body. As far as weight loss there is exercise, diets, pills, and different surgical procedures. Diet pills have become a very popular supplement to assist in weight loss, but with diet pills come many questions; are they safe, do they really work, and mainly if they are a good product or not. In order to know whether or not something a quality product, is to know how it works. The ingredients are very important and unfortunately not every diet pill has the same ingredients. There are multiple types of pills, with different effects, and conditions. There are three popular types of pills. There are appetite suppressors, metabolism regulators, and fat absorbing pills. Combining these effects into one pill with the correct usage creates positive results.
With the use of newly experimental drugs the possibility for side effects to appear, causing uninformed health risks, adds an element of danger not often brought to the forefront until a legal case is brought to court. Fen-fen, the prescription diet drug is probably the most notorious in this sense in that the manufacturers lost a settlement for millions due to the fact that the drug was found to weaken heart muscles in some users.