PhRMA's clinical trial database is up and running, and introduced as follows:
The ClinicalStudyResults.org site is a central, widely accessible, web-based repository for clinical study results in a reader-friendly, standardized format. This database will serve the valuable function of making clinical trial results for U.S.-marketed pharmaceuticals more transparent. More importantly, it is designed as a key tool to provide information to practicing physicians and their patients.
It's small, but it's a start:
URL: http://www.clinicalstudyresults.org/
You can also find information in the GlaxoSmithKline Clinical Trial Register:
URL: http://ctr.gsk.co.uk/welcome.asp
Know your information source: The FDA is the federal agency in charge of approving drugs for commercial use in US (among other things). FDA information resources are exhaustive and authoritative. Using the links below, you can find out when, or if, a drug was approved for use, the uses for which it's approved, and who is licensed to manufacture it. FDA approved information about a drug is published in the package insert: this is often called the drug label
, or the Professional Prescribing Information
. This sheet contains information about pharmacology, dosage, indication[s] for use, warnings and contraindictions, adverse events, and known drug and food interactions. A number of the more recent package inserts offer synopses of clinical trial data in tabular form. If you want the most detailed information about a drug, you should read the package insert. In some cases, especially for newer drugs, package inserts are available in the FDA drug database [Drugs@FDA]. RxList and Drugs.com have an excellent selection as well. You can also ask your pharmacist for the package insert when you pick up your prescription. A physician or pharmacist should also be able to provide you with a copy of the package insert from the Physicians Desk Reference. If else fails, write or email the drug manufacturer and ask for a copy of the package insert.
The package insert, however, since it's aimed at health professionals, can be difficult for many consumers to read. They also tend to be written in annoyingly tiny print. FDA also approves a Patient Information Sheet
which is based on the information in the package insert and written in easy-to-read language. It should go without saying that your physician should be able to answer your questions too. Don't overlook your pharmacist either: they can be excellent resources for drug information.
In a pinch, if there are words you don't understand, try the one or more of the following resources:
You can find an English dictionary on the BioethicsWatch Tools page – select the Tools
link at the top of this page.
Don't be shy about looking up the meaning of words or asking for clarification: people know
what they do, as they saying goes, and patients aren't expected to have advanced scientific training. Health care professionals, however, are obliged to explain things in terms their patients can understand – it's part of their job, and every now and then, everyone needs a reminder of this.
2004-10-04: FDA has put together several informational web pages for women considering or using replacement hormone treatment, including summaries of clinical trials, links to published studies, a list of approved drugs with Professional Prescribing Information, and links to find additional sources of reliable information. Women to whom bio–identical
hormones have been suggested should read the testimony of Adrian Fugh-Berman MD before making up their minds:
Testimony of Adrian Fugh-Berman MD, Associate Professor, Georgetown University School of Medicine [2004-07-22]
Before the House Committee on Government Reform, Subcommittee on Wellness and Human Rights,
Balancing Act: The Health Advantages of Naturally Occurring Hormones in Hormone Replacement Therapy
URL: http://reform.house.gov/UploadedFiles/gtown%20testimony.pdf 
FDA information on hormone replacement therapy – URL: http://www.fda.gov/bbs/topics/news/2004/NEW01121.html
Many drugs are prescribed for so-called off label uses
, and this can be a source of great confusion for consumers. One reason many drugs are prescribed off label is a direct result of the way in which drugs are approved. In order to market a drug in the US, FDA requires the manufacturer to provide competent scientific evidence that the drug is safe and effective. Practically speaking, this means data from clinical trials. If or when the drug is approved for marketing, the illness or disorder for which the drug was tested becomes the indicated use
on the label. Once a drug has marketing approval, however, FDA does not regulate the uses for which it can be prescribed by physicians. Off label use requires the physician to base his or her recommendation on sound medical judgment and reliable evidence that the drug is likely to work as intended for the patient. At this point many people wonder why some drug indications are not on the label if there is clinical trial data suggesting or demonstrating safety and efficacy. The answer is complicated but economic interest plays an important part. Even if clinical trial data exists, if the drug's patent has expired, manufacturers aren't terribly motivated to spend the money for a New Drug Application [necessary to change the indications on the label] if, once they've been granted the new indication, all their competitors can simply apply to produce the same drug. In addition, not every clinical trial meets FDA's requirements, so a manufacturer might have to spend money conducting trials. In the absence of patent protection, few companies are interested in doing so.
Prescribing drugs off label has advantages and disadvantages. If you're concerned about an off label prescription, ask your physician to explain why they prescribed the drug. More information about the off label use of drugs is available at the bottom of this page.
Contact Information, FDA Division of Drug Information:
Telephone: 1-888 INFO-FDA; 1-888 463-6332 or (301) 827-4570
Correspondence: Division of Drug Information
5600 Fishers Lane, HFD-240
Rockville, MD 20857
In 2002, the Best Pharmaceuticals for Children Act became law. The law was designed to increase information on drug safety and efficacy in children, which is often lacking because most drugs get marketing approval based upon clinical trials on adults. In typical fashion, the act follows the carrot-and-stick approach: it offers drug manufacturers an extra six months of patent exclusivity if they conduct pediatric trials, and it simultaneously gives FDA a bit more leeway, namely the authority to request
certain manufacturers conduct pediatric studies, and the right to disclose the results of studies conducted under the BPCA. All the agency evaluations of the studies concluded to date are available below.
Index of MedWatch Articles and Publications (excellent resource)
FDA Medical Bulletin – before the advent of the internet, FDA published an outstanding periodical to keep the medical community up to date on drug safety and other developments.
FDA Quarterly Data Extract from the Adverse Event Reporting System (AERS). Go to the National Technical Information Service (NTIS) Search page at: http://www.ntis.gov/search/index.asp?loc=3-0-0
Enter AERS
as the search term.
Keep in mind: if you're looking for information on adverse drug reactions, this data may not be the most sensible way to find it. The cost is relatively high: to access this data, you're required to purchase an annual subscription for $495, and then you must supply your own database program to organize and search the data. While FDA redacts identifying personal medical information, they do no other editing. And since there is no restriction on who can file a MedWatch Report or what information they can file, AERS data is anything but indicative of cause and effect relationships. One strategy to try is searching PubMed — The National Library of Medicine for case reports of adverse events with the drug in question. You should also look up the drug in the FDA database at Drugs@FDA to check for warnings or labeling revisions, the so-called Black Box Warnings
.
FDA published narrative summaries of drug adverse event reports for 1995 and 1996:
FDA Index on Medication Errors
FDA Vaccine Adverse Event Report System [search the on-line database for VAERS; report an adverse event; find information on vaccines
Post-marketing surveillance for adverse
events after vaccination: the national Vaccine Adverse Event Reporting System
[a CME article for health professionals, this nevertheless gives a straightforward overview of how the reporting system works]
Generally Recognized As Safe)
Use of approved drugs for unlabeled indications
FDA Drug Bulletin, Volume 12, No. 1, April 1982, pp. 4-5
URL: http://www.bioethicswatch.org/pubs/FDA_MedBull.pdf
Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the
practice of medicine
does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.
Source: US Food – Drug Administration, Off-Label
and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices, INFORMATION SHEETS, Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update
Accessed on 2004-08-28 at: http://www.fda.gov/oc/ohrt/irbs/offlabel.html
Unapproved Uses of Prescription Drugs
Testimony of William B Schultz, Deputy Commissioner for Policy, Food and Drug Administration, Public Health Service, U.S. Department of Health and Human Services; Before the Senate Committee on Labor and Human Resources, February 22, 1996
URL: http://www.os.hhs.gov/asl/testify/t960222a.html
FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions
J M Beck & E Azari, Food and Drug Law Journal vol. 53 (2001) pp. 71-104
URL: http://library.lp.findlaw.com/articles/00081/001502.pdf
Improving Patient Care by reporting problems with medical devices
[FDA CME article for health professionals describing the medical device adverse event reporting system]
FDA and the Internet Advertising and Promotion of Medical Products (1996-10-16) amazing historical document
NIH Public Thalidomide Meeting [1997-09-09]
NIH Public Thalidomide Meeting [1997-09-10]
Managing the Risks From Medical Product Use
(1999)
Last Updated: 2004-11-17
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