FOREIGN CLINICAL TRIALS ARE BECOMING A GROWING CHALLENGE FOR THE FDA TO MONITOR & REGULATE
1st Concrete Evidence Collected By Independent Sources Analyzes The Explosion In Overseas Clinical Trial Activities & Potential For Abuses
Important investigation published in the latest exciting issue of Biomedical Market Newsletter(R)
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COSTA MESA CA USA -- MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) -- OCT. 27, 2001 -- An important 15,000 word study that presents the first concrete independent evidence on overseas clinical trials activities, has been published in the Oct. 26, 2001 issue of Biomedical Market Newsletter(R).
"Globalization of Clinical Trials; A Growing Challenge In Protecting Human Subjects," details and analyzes the incredible growth in the phenomenon of US medical product manufacturers conducting required clinical trials overseas.
The controversial report, which is sure to raise criticism within the medical industry as well as in Congress, was conducted by the DHHS Office of the Inspector General (OIG), and released in recent days.
The fascinating new 18-page study, published within the 68-page BMN issue, determined that the number of foreign clinical investigators increased 16-fold over the past decade. The countries that have experienced the largest growth in recent years are Russia and Eastern Europe.
In particular, the total of number of countries where these clinical trials have been or are being conducted, has increased from 28 in 1990, to 79 in 1999. That astonishing growth rate is expected to continue in coming years, fueled in part by the impressive ability of foreign trial sites to recruit patients. On average, any Russian clinical trial site recruits twice as many subjects as any site in Western Europe, for example.
The landmark article raises a number of potentially difficult and expensive policy issues that the FDA will have to face, such as the documented problems and potential for abuses to continue. Especially troubling is the FDA's lack of resources to face this new challenge, as well as its limited regulatory authority in foreign countries -- a situation that often requires the involvement of diplomats and even Parliaments.
Furthermore, legitimate concerns were raised about the validity of data that is collected. Perhaps even more troubling is that the OIG determined that not all foreign clinical trial investigators have signed an "attestation" that they will uphold human subject protection. The OIG also claims that in general, the FDA has little or no information about the clinical trial sites, investigators, Institutional Review Boards (IRBs) and human subjects.
Clinical trials are generally considered to be hugely less expensive for US medical companies to conduct outside the US than domestically. But the reverse is true for the FDA, where just the airfare alone to some countries exceeds the total cost of an equivalent domestic inspection, which is approx. $2,500.
"The startling evidence and conclusions present a troubling picture that have government officials concerned," notes Dave Anast, Publisher/Editor/CEO Biomedical Market Newsletter. "If steps are not taken soon to improve the serious situation, it may quickly grow out of control," he stresses. "Also exacerbating the problem are restrictions on foreign travel that were placed on all FDA officials following the Sept. 11 tragedy," he says.
Important new information is presented in a 7-page article, "Reimportation of Pharmaceuticals Into The US Is Becoming A Significant Problem; Practice Encourages Entrance Of Counterfeit Bulk Drugs." In particular, FDA and other government officials are finding that reimported US-made drugs may not have been stored under proper conditions, or may not be the real product.
Surprisingly, very few, if any, Internet sites investigated by the FDA require a prescription from a US practitioner. The potential for abuse has quickly become huge, with an estimated 300-400 Internet sites currently selling prescription drugs, and more sites coming on-line daily. Approx. half the websites are based in the US, officials estimate.
OTHER ARTICLES INCLUDED IN THIS IMPORTANT ISSUE, PRINTED IN 4-COLOR:
-- Agreements Signed By US & UK To Collaborate On Healthcare Quality & Bioterrorism
-- American Public Health Assn Executive Director Wants Vaccines Made Available To The Public Now
-- Anthrax Plans Released
-- Anthrax Questions & Answers
-- CDC Investigation Of Anthrax Released
-- DHHS Releases $50 mln To Fund 94 New Research Grants, Contracts & Projects, To Help Reduce Medical Errors & Improve Patient Safety
-- DHHS Sec. Tommy Thompson Testifies on Bioterrorism
-- FDA Acts To Approve Other Drugs To Treat Anthrax Exposure
-- FDA Acts To Improve Ability To Monitor Marketed Pharmaceuticals
-- FDA Announces Reuse Policy Changes; Changes In Enforcement Of FDA's Requirements On Reprocessing Single-Use Devices
-- FDA CDRH Organization Structure, w/Phone Numbers
-- FDA CDRH Strategic Plan Released
-- FDA Says It Does Not Intend To Enforce Premarket Requirements For Reprocessing Catheters
-- French Drug Firm Pleads Guilty To Felony For Defrauding The FDA
-- Hong Kong & Asian Medical Industry Websites
-- Life Expectancy Hits New High of 76.9 Years
-- Medical Device Labeling Regulations Released By The FDA
-- New Global Health Issues Website Launched
-- Only 4 Weeks Before Sept. 11 & 2 Months prior To Anthrax Cases, DHHS Released Plans To Address Bioterrorism Threat
-- Organ & Tissue Donation Groups Receive $10 mln DHHS Award To Increase The Number Of Donors
-- Orthopedic Market
-- Orthopedic Market: Hip Fracture Patients
-- President Bush Speaks To The American Society Of Anesthesiologists
-- Push Pack Emergency Supplies Were Used In NYC Disaster, As Part Of 1st-Ever Use Of National Pharmaceutical Stockpile
-- Sentinel System Launched To Monitor US Blood Supply On A Daily Basis
-- Systems To Screen Plasma For HIV & Hepatitis C Approved By FDA; Antigen Testing Cuts The Window Period For Detection
-- Taking Cipro To Protect Against Anthrax May Not Be Such A Great Idea; Epilepsy Foundation Warns It May Cause Seizures In Some People
-- Terrorism Concerns Hit Medical Conferences: How Bad is The Damage?; New Market Research Study Is Launched To Find Out
ABOUT BIOMEDICAL MARKET NEWSLETTER(R)
Biomedical Market Newsletter(R), founded 1991 by David G. Anast, is the leading new business development, market research, competitive intelligence and FDA/regulatory monthly newsletter. Each issue is approx. 60-120 pages and packed with valuable original content and difficult-to-find data, statistics and information. BMN Inc, which publishes over 50 medical trade publications, is independently owned and operated.
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