Foods, Cosmetics, and Drugs
In 1883, Dr. Harvey Wiley became chief chemist of the Agriculture Department's Bureau of Chemistry. He was called the "crusading chemist" and "Father of the Pure Food and Drugs Act." At the time, there were increasing concerns over the use of untested chemicals in foods to preserve them. In 1902, Dr. Wiley persuaded Congress to appropriate funds to investigate whether such preservatives should be used in food and how much actually was safe for consumption.
Dr. Wiley began his investigations by recruiting volunteers to eat foods containing measured amounts of borax, salicylic acid, formaldehyde, and other chemical preservatives. His volunteers were given the name of the "Poison Squad." Many of the young male volunteers became sick, and the experiment was stopped. Wiley advocated that chemical preservatives be used only when necessary, and that the producers of chemically preserved foods should inform the consumers about the ingredients by listing them on the food labels.
These studies drew widespread attention to the problem of food adulteration and increased public support for government intervention. The "hygienic table studies," as Dr. Wiley called them, were pivotal to the enactment of the original Food and Drug Act of 1906. On June 30, 1906, Congress passed the original Pure Food and Drug Act, which was signed into law by President Theodore Roosevelt.
The Pure Food and Drug Act of 1906 prohibited misbranded food, drinks, and drugs in interstate commerce and was enforced by the Bureau of Chemistry in the Department of Agriculture. The Bureau of Chemistry was reorganized in 1927 and separated into two entities: the Food, Drug, and Insecticide Administration (FD&I) responsible for regulatory functions and the Bureau of Chemistry and Soils responsible for nonregulatory research. In 1930, the FD&I shortened its name to the Food and Drug Administration (FDA).
In the mid-1930s, the elixir sulfanilamide was marketed by S. E. Massengill Company of Bristol, Tennessee. Diethylene glycol, a poisonous chemical relative of antifreeze contained in the elixir, led to the deaths of 107 people. This tragedy brought about The Food, Drug, and Cosmetic Act of 1938, which required new drugs to be shown safe before they were marketed to the public.
In 1951, the Durham-Humphrey Amendment was enacted to define drugs that cannot be safely used without medical supervision and to restrict their sale to prescription by a licensed practitioner. The act, which became known as the Prescription Drug Amendment, established two classes of drugs: prescription and over-the-counter (OTC) drugs. It granted the FDA the authority to categorize prescription drugs as those that are habit forming and unsafe for use except under the supervision of a healthcare practitioner.
The next major amendment related to drugs came in 1962 with the Kefauver-Harris Drug Amendment. Findings showed that thalidomide, a new sleeping pill, had caused birth defects in thousands of babies born in Western Europe. Dr. Frances Kelsey, FDA Medical Officer, played a pivotal role in keeping the drug off the U.S. market and raised public support for stronger drug regulations. The Kefauver-Harris Drug Amendment required drug manufactures to prove to the FDA the effectiveness of their products through adequate and well-controlled studies. In addition, the Amendment also required informed consent of study subjects, the reporting of adverse events, and the establishment of rules for the investigation of new drugs.
Oral contraceptives were the first to have patient package inserts in 1970. These inserts were required to contain information about specific benefits and risks in a language that the patient could understand. Emphasis on OTC labeling came about in 1972 when the FDA began reviewing nonprescription drugs for safety and effectiveness.
Anti-tampering regulations were passed in 1983 in response to the 1982 deaths of 7 people in Chicago after taking Tylenol capsules contaminated with cyanide. Caplets replaced capsules, making it harder for the product to be contaminated. The FDA required most OTC drugs to be packaged in tamper-resistant packages, with the tamper-resistant measures described on the label. The Act also made tampering with consumer products a felony punishable by up to 10 years in jail.
Key changes in the late 1980s and 1990s expanded the demographics in clinical trials. The inclusion of representative populations has assisted experts in analyzing results for possible differences in drug response among demographic subsets. Some of these key changes include the following:
* Guidelines issued by the FDA in 1989 asking manufacturers to determine whether a drug is likely to have significant use among older people and to include older patients in clinical studies.
* The Gender Guideline issued in 1993, calling for assessments of medication responses among both genders.
* The Demographic Rule issued in 1998, requiring that a marketing application analyze data on the safety and effectiveness a drug by age, gender, and race.
* The Best Pharmaceuticals for Children Act passed in 2002 to improve the safety and effectiveness of medicines for children.
If you are interested in reading more about the history of the Food and Drug Administration (FDA), log onto the FDA's Web site at: http://www.fda.gov/default.htm.
SOURCE
Swann, J. P. (n.d.). History of the FDA. [Adapted from George Kurian, ed., A Historical Guide to the U.S. Government. New York: Oxford University Press, 1998.] Retrieved November 9, 2006 from http://www.fda.gov/default.htm
Experts are predicting a worldwide epidemic of hip fractures over the next few decades. As we age, our bones begin to weaken from osteoporosis, leaving us vulnerable to fractures. Osteoporosis is a debilitating disease that can be prevented and treated. Left untreated, osteoporosis can progress painlessly until a bone breaks. The broken bones, typically known as fractures, occur in the hip, spine, and wrist. Of special concern are fractures of the hip because they almost always require hospitalization and major surgery. A fracture episode can impair a person's ability to walk unassisted and may cause prolonged or permanent disability and even death.
Calculating the Costs: Sobering Facts
* A study published in 1994 estimated that the total direct medical costs for osteoporotic fractures among postmenopausal women in the next 10 years will exceed $61.2 billion (Chrischilles et al., 1994).
* In the United States, hospitalization accounts for 44% of the direct healthcare costs for hip fracture patients (Barrett-Connor, 1995). In 1991, the Medicare costs for this injury were estimated to be $4.7 billion (Centers for Disease Control [CDC], 1996).
* Hospital admissions for hip fractures among people older than 65 years have steadily increased, from 230,000 admissions in 1988 to 338,000 admissions in 1999 (Popovic, 2001). The number of hip fractures is expected to exceed 500,000 by the year 1030 (Brainsky et al., 1997; Cooper et al., 1992).
Prevention is the key, according to Dr. Joseph Fetto, associate professor of orthopedics at the New York University Hospital for Joint Diseases. Osteoporosis is a degenerative disease, with bone strength largely determined by the body's store of calcium. According to Fetto, the research has shown that calcium content peaks relatively early in life, in the 20's, then declines slowly but steadily as the years go by. Preventing the epidemic of hip fractures could be as simple as ensuring that today's younger people get adequate amounts of calcium, magnesium, zinc, and vitamin D in their diets. Fetto stated that "it would not be an expensive proposition," then went on to state that the World Health Organization has shown the cost would be about 30 cents per day to prevent osteoporosis (Edelson, n.d.).
To find out more about osteoporosis, go to the American Academy of Orthopaedic Surgeons Web site at http://orthoinfo.aaos.org/main.cfm.
NQF Releases Palliative Care Framework Document
The National Consensus Project for Quality Palliative Care (NCP) welcomes the release of a new publication from the National Quality Forum (NQF), A National Framework for Palliative and Hospice Care Quality Measurement and Reporting. The framework is based in part on the Clinical Practice Guidelines for Quality Palliative Care, issued in May 2004 by the National Consensus Project, a consortium of palliative care and hospice organizations including the National Hospice and Palliative Care Organization.
The report highlights consensus practice guidelines approved by NQF's more than 300 member organizations through its formal Consensus Development Process. As such, the voluntary consensus guidelines have special legal standing. NQF reports are highly influential. In addition, the report includes 38 preferred practices, based on the 8 domains of care, as well as a call for research.
Two key partners in the production of this report are the Robert Wood Johnson Foundation and the U.S. Department of Veterans Affairs. The NQF Framework offers a set of expectations and associated best practices designed to meet rigorous standards. In contrast, as part of the NCP's more expansive mission to raise awareness of the need for quality care, the NCP Guidelines provide historical and philosophical background on the field and suggest a range of recommended practices that should be in place in all care settings and communities.
Information on the Framework, including the executive summary and ordering information is available in the Publications section of the NQF Web site, http://www.qualityforum.org.
The NCP Guidelines can be downloaded for free at http://www.nationalconsensusproject.org. Print copies of the NCP Guidelines are available for purchase from the NHPCO Marketplace (visit http://www.nhpco.org/marketplace or call 1-800-646-6460).
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