NIH researchers create comprehensive collection of approved drugs to identify new therapies

                                                                                                   http://www.ncgc.nih.gov/

From the 27 April 2011 Eureka News Alert

Researchers have begun screening the first definitive collection of thousands of approved drugs for clinical use against rare and neglected diseases. They are hunting for additional uses of the drugs hoping to find off-label therapies, for some of the 6,000 rare diseases that afflict 25 million Americans. The effort is coordinated by the National Institutes of Health’s Chemical Genomics Center (NCGC).

“This is a critical step to explore the full potential of these drugs for new applications,” said NIH Director Francis S. Collins, M.D., Ph.D. “The hope is that this process may identify some potential new treatments for rare and neglected diseases.”

The researchers assembled the collection of approved drugs for screening based on information from the NCGC Pharmaceutical Collection browser at http://tripod.nih.gov/npc. This publicly available, Web-based application described in a paper appearing in the April 27 issue of Science Translational Medicine, provides complete information on the nearly 27,000 active pharmaceutical ingredients including 2,750 small molecule drugs that have been approved by regulatory agencies from the United States, Canada, Europe and Japan, as well as all compounds that have been registered for human clinical trials……

Related Rare Diseases Resources

• National Organization for Rare Disorders
• Genetic and Rare Diseases Information Center(Office of Rare Diseases, National Human Genome Research Institute)
• Office of Rare Diseases
• Rare Diseases Clinical Research Network(Office of Rare Diseases, National Center for Research Resources)
• Rare Diseases (MedlinePlus)

Related Articles

• Push to spur more drugs for deadly rare diseases (seattletimes.nwsource.com)
• U.S. Rolls the Dice on Pharmaceutical Drug Innovation (livescience.com)
• Guidelines on rare diseases: Methods on handling evidence neither identified nor required

  Manuals and methods papers provide only isolated references; different requirements than those for more common diseases do not seem meaningful

Off-Label Promotion Analyzed, Fixes Involve Docs

From the April 6 2011 MedPage Today article

By Cole Petrochko, Staff Writer, MedPage Today

Healthcare professionals are the best defense against illegal off-label*** marketing of drugs, researchers found. “Our findings suggest that no regulatory strategy will be complete and effective without physicians themselves serving as a bulwark against off-label promotion,” Aaron S. Kesselheim, MD, MPH, of Harvard, and colleagues wrote in the April issue of PLoS Medicine. Despite regulations against off-label marketing, the practice appears to have fluorished in the last several years, the researchers noted. To get a better understanding of the problem, they analyzed whistleblower-initiated legal complaints filed in off-label marketing cases over the last 15 years…. … Prescriber-related practice complaints included: Encouraging healthcare professionals to prescribe for off-label use through false or unbalanced study data (76% of all prescriber-related practice complaints) Distributing free samples as a convenient source of off-label promotion (20%) Providing “lavish gifts” or honoraria to healthcare professionals (85%) Creating CME activity with speakers known to promote off-label use or through shell corporations (54%) Payer-related practice complaints included: Discussions with prescribers to ensure insurance reimbursement for off-label prescriptions (78% of all payer-related practice complaints) Discussions with payers to ensure insurance reimbursement for off-label prescriptions (35%) Advice on ways to bypass an insurer’s restrictions on a drug’s prescription (53%) Falsification of billing codes (48%)   ***Off-label use: In the United States, the regulations of the Food and Drug Administration (FDA) permit physicians to prescribe approved medications for other than their intended indications. This practice is known as off-label use [MedicineNet.com definition]

 

Related Articles

• Top Three Off-Label Marketing Strategies and Tactics (goodpromotionalpractices.com)
• Off-label marketing of medicines in the US is rife but difficult to control (eurekalert.org)
• More on Off-Label Promotion and the False Claims Act (druganddevicelaw.blogspot.com)
• A Godzilla Of A New Third Party Payer Dismissal (druganddevicelaw.blogspot.com)
• Off-label marketing of medicines in the US is rife but difficult to control (physorg.com)