Patients Should Reap the Benefits of Data Collected by the FDA

Over the past decade, the Food & Drug Administration has made great efforts to provide improved safety information to patients and consumers. The FDA web site includes a number of helpful materials: warning labels, podcasts white papers prepared for scientific panels that summarize complex medical and scientific data Power Point presentations made to scientists and FDA employees "Dear Doctor" letters informing physicians of changes in drug labeling DDMAC enforcement letters for violations of federal law in marketing products The Agency started publishing watch lists and frequent Safety Alerts regarding drugs and medical devices with potential safety issues, which has directly benefited patients who were able to choose better options for their healthcare and avoid harm. Consumers can also request email updates and an RSS feed from the FDA. Pictures of food and drug products recalled by the FDA are included on flickr, and there are videos and other materials in multiple languages available to consumers at www.fda.gov. For years, the MAUDE (Manufacturer and User Facility Device Experience) database has been available online to help patients and others search for information about adverse event reports for defective medical devices. The MAUDE database includes data submitted by patients, doctors, manufacturers, and others with regard to various FDA-approved medical devices that have malfunctioned or were found to be defective and caused a patient death or serious injury. The medical device database includes reports going back to approximately 1991. The publicly-accessible materials from the FDA do not include compilations or analysis of the data, but are nevertheless very helpful in analyzing the safety and performance of various medical devices. While patients can submit adverse event reports directly to the FDA for serious reactions, injuries, and side effects associated with prescription drugs directly to the FDA through online submissions, the data from those AERs is not readily available to the public, physicians, lawyers, and others who are interested in drug safety. Historically, lawyers who were involved in lawsuits against the manufacturers of defective drugs would have to fight through the court system to obtain adverse event report forms and compilations from the manufacturers and then engage in the tedious process of piecing together the reports in order to substantiate trends and signs of red flags that should have motivated the drug companies to recall a particular unsafe drug or at least enhance the warnings to patients and prescribing physicians. Third party vendors were often used to tap into the FDA's drug safety databases and translate the archaic and confusing data. Hopefully, the FDA will work in coming years to provide the public with access to all the information available on medical devices in the MAUDE database, rather than just some of the information. This week two companies announced that they would work to demystify the FDA's drug and medical device safety and adverse event databases and make that information readily available to the public, with some of this information being provided for free while more in-depth analysis would require a subscription. Clarimed's website will focus on safety reports with regard to more than 125,000 medical devices, while AdverseEvents Inc. will help to shed light on prescription drug-related adverse event reports. This is a significant step towards resolving a crisis that currently exists in this country, where patients are being prescribed drugs based upon improper and unsubstantiated claims of benefits made by aggressive manufacturer marketing. Consumers are denied ready access to unbiased, truthful information about hazards, risks, and emerging safety issues; leaving them only with information conveyed through drug company ads. Hopefully, our drug safety system will continue to evolve and improve through the efforts of consumer advocates, lawyers, physicians, regulators, and patients to ensure that physicians and their patients are able to make the very best and informed decisions (including a thorough weighing of risks versus benefits) regarding the use of medical devices and drugs.

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