Recently in pharmaceuticals Category
Becky Huting, MJLST Articles Editor
While recently home in Chicago on spring break, I offered to make my dad a spinach-packed smoothie. My dad (a good sport) agreed, but asked me to make it light on the spinach as he understood men at his age (60) should be taking it easy on the iron intake. I had heard this principle before, and knew that men's and women's vitamin supplements were different in part due to the additional iron needs of women. My dad was right about one thing: he needs a lot less iron than me. His recommended dietary allowance for iron is 8 mg/day whereas mine is a lofty 18 mg/day. In actuality, men rarely suffer from iron deficiency so supplements are usually unnecessary, and in fact too much iron can indeed be harmful. There are possible links with excessive iron consumption to diabetes as well as neurodegenerative disease.
But where his concerns are unfounded are in the nutritional numbers. One cup of uncooked spinach contains only .8 mg of iron. That is only one-tenth of his daily iron needs. Three ounces of ground beef containing 15% fat contains 2.2 mg of iron. What about his daily serving of canned, drained clams, you ask? Fine, you have me there: if my father actually consumed such item, he'd have gone over at 23.8 mg of iron. It is very hard though for a human to overdose on iron from food, because an adult body has systems in place to regulate the amount of iron it absorbs. In short, my dad need not be concerned about spinach in his smoothie, except for reasons of palatability.
So given the different nutritional needs of men, women, and also children, what entity is telling consumers whether a vitamin is for them by way of labels? The Food and Drug Administration (FDA) relinquished that duty back in October of 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. This law created a new regulatory framework for the safety and labeling of dietary supplement that places the responsibility on the product manufacturers rather than the FDA. The DSHEA was a response to lobbying by health food companies to vote down several bills that would have had the effect of increasing the FDA's powers over supplement labeling. Celebrities even got involved. In one commercial, Mel Gibson portrayed a citizen being raided and arrested by FDA agents for possessing a bottle of Vitamin C.
This mentality that too much government oversight is a bad thing is a popular ideal. After all, it's only a vitamin. Perhaps a label signifying use by pregnant and nursing moms is enough, but consider the 60-year-old guy grabbing this supplement in haste. He is now getting 27 mg iron per day from the vitamin alone, perfect for a pregnant woman, but over 3X his nutritional needs. Are a few words on a label enough to signify safety to a consumer? Certainly there is an argument that too much information will lead to a cluttered, confused label. So where do you come down, bring the FDA back in or leave it to the companies? And do you feel like a green smoothie? I promise you the banana masks the spinach flavor.
Thomas Hale-Kupiec, MJLST Staff Member
In Volume 11, Issue 1 of the Minnesota Journal of Law, Science, & Technology, Eagleman, et al. conclude that "the neuroscientific community should continue to develop rehabilitative strategies so that the legal community can take advantage of those strategies for a rational, customized approach" in Why Neuroscience Matters for Rational Drug Policy. Though perhaps this assertion is valid in the context of Drug Addiction, I believe it is necessary to limit this assertion to solely rehabilitative drug addiction studies; to allow a further extension of this conclusion would be sociologically detrimental. I postulate that beyond ideas of who we define as a "Neuroscientist," legal experts need to be at the forefront of this debate in order to better define and formulate ideas of "rehabilitation."
In a related reflection entitled 'Smart Drugs': Do they work? Are they ethical? Will they be legal?, researcher Stephen Rose poses a number of ethical and neurological impacts of mind enhancing substances. The author posits an interesting question: what is "normal" for a brain? If someone undergoes pharmacological manipulation, what should the standard be for "abnormal?" For instance, Rose poses that some substances could be used for patients with Down Syndrome to allow for cognitive enhancement. Is this a valid designation as "abnormal?" Inexorably linked to this issue would be Autism Spectrum Disorder -- where on the spectrum does a cognitive "abnormality" manifest? Further, how do we define potentially less visible disorders such as "anxiety?" With this spectrum of diseases and mental health conditions, variety of measured "abnormalities," and varying pharmacological treatment effectiveness, I think we need to be mindful that neuroscientific constructions are often blurry, but always need to be conceptualized within the paradigm of ethics.
More than ever, the question of "what is abnormal" and "what mandates treatment" needs to be addressed in pharmaceutical policy. For instance, federally designated controlled substances like marijuana may be effective at treating anxiety and other medical conditions. Should the legal community allow for Eagleman's assertion to snowball? Imagine an increasing number of states embrace evidence that the active ingredients in marijuana could treat certain medical conditions? Should the scientific community solely argue the validity of these findings? Legal professionals, bioethicists, and regulators need to be included in these questions. It is not that the data driven outcomes need to be pursued; rather, that a level of ethics and sociological morals need to be layered above these decisions.
by Daniel Schueppert, UMN Law Student, MJLST Staff
The USDA has recently lifted restrictions on the practice of shipping US Chicken to China for processing, for an eventual return to the US. Under the present regulations, chicken originating from US farms can be shipped to China for processing, then shipped back to the US for sale. This chicken need not include Country of Origin Labeling (COOL) to indicate that it has been processed in China. This change comes in the wake of a years of food safety scares relating to China's food supply. Although the Food Safety Inspection Service (FSIS) has completed audits of the China's "poultry processing inspection system" and certified some of the Chinese processing plants and procedures, American consumers have retained some reservations about the safety of chicken processed in China. As it stands, this system leaves consumers in the position of not knowing which country their chicken products have been processed because the Chinese operations are considered a comparable food component to what results from US processing.
This recent action by the USDA clearly raises questions concerning the United States' food safety, and perhaps security. A sophisticated consumer may nevertheless be able avoid chicken products known to be processed in China, but absent COOL disclosures this may be a difficult task and arguably involve some guess work. This is not necessarily the case with generic pharmaceuticals, an area in which there are substantial parallels to the chicken debate. Some of the concerns raised relating to the quality and safety of chicken processed in China also bring to light the COOL requirements for other consumables like pharmaceuticals. Import screening and labeling for pharmaceuticals, and particularly off patent generics, is a convoluted area of regulatory law where Federal agencies to not always agree. Currently many of the various components of just one pharmaceutical drug are manufactured all over the world and come from a variety of sources. Manufacturing in India, China, and Eastern Europe account for a large part of the market.
The FDA's main measure on determining the quality of components in generic drugs is a fuzzy spectrum concerning the "bioavailability" of certain chemicals but this measure does not necessarily take account of inert components or varying quality or quantities of active ingredients. Much like chicken, a consumer or regulatory agency would be hard pressed to find a problem with these products until a quality control issue develops and American consumers are put at risk. COOL labeling regarding Chicken and Drugs are developing issues without a clear regulatory action in sight. Stay tuned to the Minnesota Journal of Law, Science & Technology for further updates.
by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor
In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia--a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be "per se" protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice--that is, until recently.
by Maya Suresh, UMN Law Student, MJLST Staff
Bringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm's financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.
by Johanna Smith, UMN Law Student, MJLSTStaff
A new study published online on February 20, 2013 in the Journal of the American Medical Informatics Association found that when hospitals used electronic prescribing, it prevented 17 million drug errors--and if implemented more widely and consistently, it could prevent more than 50 million drug errors. But as of 2008, only about one in three acute care hospitals used electronic prescribing. Although there are various methods suggested to improve healthcare quality, one of the simplest is to make medical errors public. If hospitals, and the general public, were more aware of the safety benefits of electronic prescribing, this could lead to increased use and standardization. Another option to increase the use of electronic prescribing is to connect funding or reimbursement to the use of electronic prescribing.