1. Field of the Invention
The present invention relates to an enhanced method for depicting the assessment and analysis of the risks of adverse effects resulting from the use of a particular drug, either alone or in combination with other drugs, nutrients, foodstuffs, beverages, toxins, chemicals, supplements, and other substances.
2. Description of the Related Art
In September 1997, information regarding cardiopulmonary disease related to the use of fenfluramine and phentermine (“fen-phen”) prompted the United States Food and Drug Administration (FDA) to request the manufacturers of these drugs to voluntarily withdraw both treatments for obesity from the market. Subsequent studies show a 25 percent incidence of heart valve disease apparently resulting from diet drug use. Thus, up to 1,250,000 people may have sustained heart valve damage from these diet drugs and the FDA indicates that this may be the largest adverse drug effect that the agency has ever dealt with.
Current estimates are that some 2.2 million hospital patients had serious adverse drug reactions and more than 100,000 people die each year from adverse reactions to prescription drugs. Accordingly, federal officials have recommended that the FDA require hospitals to report all serious drug reactions to the agency. The Inspector General of the Department of Health and Human Services has also indicated that the FDA should also work to identify harmful effects of new drugs and encourage health-care providers to rapidly call the FDA with information about drug side effects. As new drugs are introduced at increasing rates, the FDA will likely need additional resources to protect the public from hazardous drug side effects.
If one or two adverse drug reactions slip through the FDA's reporting process, the results can be tragic for some patients. That is especially true when the adverse reactions are rare but serious—such as in the case of liver failure caused by medication. All drugs have the potential to harm or kill the people they are designed to help. An injection of penicillin can kill in minutes if the recipient is allergic to this life-saving drug. Even common aspirin can be deadly.
Clinical trials of a new drug often involve a few hundred patients and therefore may not reveal that a drug can cause serious injury or death in one patient in 10,000 or even 1,000 patients. Accordingly, it is critical for researchers and drug companies to be able to analyze and predict adverse reactions among patients in their studies.
In addition, in clinical trials for drugs used to treat diseases such as diabetes, which affects so many people and is difficult to treat, FDA officials often face tremendous pressure to accelerate their approval process. Often, in this “fast-track” process, cases of adverse drug effects may slip through reporting procedures.
An even bigger challenge to the FDA is the occurrence of adverse drug reactions after the drug is on the market. In this case the drug is prescribed to a much larger population of patients, many of whom are taking other substances such as extracts, nutrients, vitamins, hormones or drugs that might have an adverse effect with the prescribed drug.
Thus, there is a need for effective depiction of the risk analysis of adverse drug effects. Unfortunately, such a system has not been available.
U.S. Pat. No. 6,120,443 to Cohen-Laroque, “Device For Determining The Depth of Anesthesia” discloses a method for determining the depth of anesthesia by acquiring a patient heart activity signal, converting the analog signal to a digital signal, sensing a periodic wave in the signal, determining the frequency of the periodic wave in the signal, determining the digital time interval series, calculating the fractal dimension of the digital series and calculating the depth of anesthesia based on the fractal dimension. The reference also discloses a display means used to show the depth of anesthesia. The display means displays correlation dimension information.
U.S. Pat. No. 6,108,635 to Herren et al., “Integrated Disease Information System” discloses a system that supports the development of new medical interventions for diseases. The system includes Explorer modules for discovering proposed interventions, designing clinical trials, performing pharmacoeconomic analysis, and illustrating disease progression for various patients over time including creating disease progression tutorials for a patient. The system also includes the ability to display correlations or relationships between selected input variables and disease progression measures. This graphical representation allows users to better understand and visualize patterns in the data that inform the clinical trial process.
U.S. Pat. No. 6,151,581 to Kraftson et al., “System For And Method Of Collecting And Populating A Database With Physician/Patient Data For Processing To Improve Practice Quality And Healthcare Delivery” discloses a system and method for administrating a patient management and health care management database. The database is built from data collected via patient surveys and contains data relevant to the clinical care of patients, the management of the practices to which the patients belong, and to the outcome of that health care and practice management. Once the data is collected from the patient, the data is entered in digital format and stored in a relational database. The data is then analyzed and prepared for dissemination. As part of the analysis, the data is scaled, scored and subjected to a battery of statistical tests that result in a series of correlative relations. The analyzed data is then presented in a printed or graphical format.
U.S. Pat. No. 6,098,062 to Janssen, “Argument Structure Hierarchy System And Method For Facilitating Analysis And Decision-Making Processes” discloses a system and method for facilitating decision making. At the heart of the system and method is a computer program that links data representing argument structure units into a hierarchical argument structure. Each argument structure unit includes data representing a hypothesis and its corresponding counter-hypothesis, data corresponding to grounds that provide a basis for the hypothesis or counter-hypothesis, data linking the grounds to the hypothesis or counter-hypothesis, and supporting data. Once all the inputs have been acquired, the hierarchical argument structure may be used for decision-making. Visualization programming code displays the support for and against each hypothesis at each node in the hierarchy.
U.S. Pat. No. 6,076,083 to Baker, “Diagnostic System Utilizing A Bayesian Network Model Having Link Weights Updated Experimentally” discloses a diagnostic system, which utilizes a Bayesian network model having link weights updated experimentally. The system includes an algorithm for quantifying the strength of links in a Bayesian network, a method for reducing the amount of data needed to automatically update the probability matrices of the network on the basis of experiential knowledge, and methods and algorithms for automatically collecting knowledge from experience and automatically updating the Bayesian network with the collected knowledge. The reference also discusses structuring the display of evidence data so that it can be more easily filtered and accessed. In particular, the disclosure includes a graphical display means for displaying problems and diagnoses. The display means provides high level information with the ability to choose to display the underlying data that formed the basis of the high level information.
U.S. Pat. No. 5,692,171 to Andres, “Method of Extracting Statistical Profiles, And Use Of The Statistics Created By The Method” discloses a method of extracting statistical profiles from a relational data base organized by relation, attribute, and index. The profiles are arranged in tables that are included in the database. The reference also discloses a method of profile extraction that can be adapted to any data type.
Japanese Patent No. 11282934, “Medicine Preparation and Medical Diagnosis Support Device” discloses a device that stores patient information, medicine information, examination information, etc. The device also includes a display processing part, which can display the medication information and examination data on the same time base.
Japanese Patent No. 10225500, “Drug Store and Drug Store Information System” discloses a system to indicate the safety and effectiveness of two or more drugs prescribed at the same time. The system allows a user to select the drugs being prescribed from a medical supply table. The system then returns information about the drugs, which allows a doctor to judge their safety and effectiveness.
U.S. Pat. No. 6,219,674 to Classen, “System for creating and managing proprietary product data” discloses systems and methods for creating and using product data to enhance the safety of a medical or non-medical product. The systems receive vast amounts of data regarding adverse events associated with a particular product and analyze the data in light of already known adverse events associated with the product. The system develops at least one proprietary database of newly discovered adverse event information and new uses for the product and may catalog adverse event information for a large number of population sub-groups. The system may also be programmed to incorporate the information into intellectual property and contract documents. Manufacturers can include the information in consumer product information that they provide to consumers or, in the case of certain medical products, prescribers of the medical products.
However, none of these references provides an enhanced method for depicting the assessment and analysis of the risks of adverse effects resulting from the use of a particular drug, either alone or in combination with other drugs, nutrients, foodstuffs, beverages, toxins, chemicals, supplements, and other substances.
Thus, there remains a need for an enhanced method for depicting the assessment and analysis of the risks of adverse effects resulting from the use of a particular substance, either alone or in combination with other drugs, nutrients, foodstuffs, beverages, toxins, chemicals, supplements, and other substances. There also remains a need for an enhanced method for depicting the assessment and analysis of the risks of adverse effects resulting from the use of a particular drug, either alone or in combination with other drugs, foodstuffs, beverages, toxins, chemicals, nutrients, supplements, and other substances.