Chapter 15 Homework 1. You have developed a new type gold nanoparticle to improve a physician’s ability to detect cancer at the earliest possible stages. Many internet based health food stores sell solutions of identical gold nanoparticles to “lift your body's performance, and fight off germs, viruses, bacteria, allergens, pathogens and pollution”. Yet, it will be several years before you can begin clinical trials to determine whether this same nanoparticle can improve early cancer detection. http://alchemistsworkshop.com/_wsn/page8.html a. Describe the current differences in FDA regulation of this particle when it is used as a dietary supplement vs as a drug. b. Briefly summarize the history of government regulation of drugs in the US, noting the year of major changes in legislation and the primary changes in regulation associated with these laws. c. Consider the differences in regulation of drugs and dietary supplements. d. If I wish to market a new dietary supplement which I claim will improve immune function, am I obligated to provide scientific data to the FDA indicating that it is safe and/or effective before I can sell it? e. If I wish to market a new drug to treat pancreatic cancer, am I obligated to provide scientific data to the FDA indicating that it is safe and/or effective before I can sell it? f. The following is an actual internet ad for an herbal supplement. If you were employed by the FDA to monitor and investigate these ads please indicate statements you see that may not follow legal guidelines in the United States. Explain why you chose each of your selections. If you did not identify anything, explain why. There's a new nutritional supplement available for people suffering from Type 2 diabetes. It's called The Body Rejuvenator, marketed by Lafayette Miracle Solutions. It contains two key ingredients -- green tea extract and cinnamon. The first thing to realize is that nutritional supplements can very successfully control blood sugar in diabetics. Both green tea and cinnamon are well-known to help control blood sugar so that you don't have such wild blood sugar swings (and potentially don't need as much insulin either). Also, there are many other benefits documented from taking both green tea and cinnamon. Green tea is noted for its anti-cancer effects, as well as its ability to aid in weight-loss, which is something that diabetics are typically concerned with. 3. I wish to market a new dietary supplement. Indicate which of the statements in the list below that I am legally allowed to put on the product label. If a statement would not be allowed, indicate why not. a. Acidophilus, Bifidus & Bulfaricus promote the health of the digestive tract. b. Black Currant Oil contains essential fatty acids that provide dietary support for normal healthy blood lipids and helps to support the cardiovascular system. c. SkinAnswer, a glycoalkaloid skin cream, as a treatment for skin cancer. d. Ephedra-free Total Lean™ helps dieters increase their metabolism and boost their energy. e. MGN-3, a rice-bran extract, a treatment for HIV, the virus that causes AIDS. f. ZantrexTM-3 promises 546% more weight loss than the leading ephedra-based diet pill and that's a fact. Here's another fact: Zantrex-3 is way beyond ephedra,way beyond fat-burners, way beyond everything on the market today. Zantrex-3 is a new category of bifurcated weight loss compounds providing both rapid weight loss and incredible energy combined into a single power-packed Super Pill. New Zantrex-3 is so powerful you won't find it in some Wal-Mart next to some "Flintrock" vitamin for kiddies. g. BeneFin, which is produced from shark cartilage, as a treatment for cancer. 4. Over the last 100 years, the role of the FDA in regulating drugs has changed significantly. Briefly describe the history of these changes. Contrast changes over time in the history of FDA regulation of medical devices. 5. Read the following article. Explain how, after passing all the safeguards of preclinical testing, phases I-III of clinical trials, and required scrutiny of an FDA panel, problems such as these could occur. F.D.A. Seeks Reports of Stent Problems April 23, 2004 By GINA KOLATA The Food and Drug Administration is actively seeking reports of possible problems with a stent that came on the market last month, saying it has heard of serious medical complications in some cases. But Dr. Daniel G. Schultz, director of the agency's office of device evaluation, said in a telephone interview on Tuesday that it was too soon to say whether there was a problem with the stent and, if so, what was causing it and what advice to give doctors and patients. The F.D.A. knows of 20 to 25 incidents, Dr. Schultz said, but the reports range from sketchy to highly detailed. "We're fairly early in the process" of assessing the reports, Dr. Schultz said. "At this stage, our main goal is to gather more information." The device's maker, Boston Scientific, says that its stent is safe and is performing excellently and that any problems are extraordinarily rare. Paul LaViolette, senior vice president at the company, said more than 70,000 of the stents had been used in the United States since the device went on sale in March. "We have to conclude, and I will say this with a lot of experience, that this product is performing extremely well," Mr. LaViolette said. But a few cardiologists reported in telephone interviews that they got into trouble after the stent, a small wire tube used to hold open arteries, was slipped into place. Like all stents, Boston Scientific's stent, the Taxus Express2, comes packaged with a deflated balloon inside. A cardiologist threads the stent with its balloon into an artery. When the site of the blockage is reached, the doctor inflates the balloon, pressing the stent against the artery wall. Then the balloon is deflated and the catheter and balloon withdrawn, leaving the stent flush against the artery, holding the vessel open. Some doctors said the balloon stuck on the stent when they were removing it. Some were able to free the balloon; some were not. Dr. William Campbell, director of the cardiac catheterization laboratory at Borgess Heart Institute in Kalamazoo, Mich., said a patient was rushed into emergency open heart surgery to remove the balloon and stent. Others, like Dr. Alejandro Prieto of Michigan State University, said that the balloon did not deflate and that he had to use a
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