E-DRUG: Glaxo Struggles To Recruit Patients For Avandia Trial
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There is troubling news on the ethics of Glaxo's clinical trials
which have recently been off-shored in an attempt to increase enrolment:
Public Citizen has written to FDA on the matter and an article from Pharmalot follows.
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Joana Ramos, MSW
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"Joana Ramos" <jdr@ramoslink.info>
Letter Urging FDA to Halt Rosiglitazone (Avandia) Trial
http://www.citizen.org/Page.aspx?pid=3312
The Public Citizen letter to the FDA is quite long. Here is the summary.
SUMMARY
The TIDE trial continues to recruit patients despite a lack of clinical equipoise, exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over its comparator. Prospective study subjects are deprived of the opportunity to make a fully informed decision because the consent form does not present an accurate portrayal of existing safety concerns. It is difficult to imagine that a patient would willingly participate in a trial involving a drug that, according to the American Diabetes Association and its European equivalent, has safety concerns that leave it with no present-day role in the management of type 2 diabetes. The TIDE trial can only continue with the misplaced objective of providing definitive proof of what many studies have already suggested: that rosiglitazone is indeed more dangerous than pioglitazone. The price of such definitive proof will almost certainly be measured in the lives of study subjects who have been incompletely informed about the risks and benefits of participation.
We respectfully request a timely response to this letter, and we hope that you agree that simply waiting to act until the FDA advisory committee meeting scheduled for July guarantees that more patients — now including those in developing countries — will be exposed to and very possibly injured by a drug that, for the reasons we have outlined, should not be in use.
Sincerely,
David N. Juurlink M.D., Ph.D., FRCPC, FACMT, FAACT
Head, Division of Clinical Pharmacology and Toxicology
Sunnybrook Health Sciences Centre
Scientist, Institute for Clinical Evaluative Sciences
Medical Toxicologist, Ontario Poison Centre
Toronto, Ontario
The piece from Pharmalot follows.
See original article for all link outs.
Glaxo Struggles To Recruit Patients For Avandia Trial
http://www.pharmalot.com/2010/05/glaxo-struggles-to-recruit-patients-for-avandia-trial/
The big drugmaker is having difficulty recruiting patients for the TIDE trial, which compares the Avandia [rosiglitazone] diabetes pill with Takeda Pharmaceutical’s Actos [Pioglitazone], but there are ongoing concerns that the study is unethical because it tests a drug with known cardiac risks with what appears to be a safer alternative. And now investigative sites have withdrawn due to poor enrollment, The Wall Street Journal reports.
One site, Wake Forest University Baptist Medical Center in North Carolina, is “not succeeding in recruiting anybody,” although efforts to enlist patients began last year, William Applegate, dean of Wake Forest’s medical school, tells the paper. The FDA, meanwhile, is considering putting an end to the trial (see here) and some physicians agree it should be ended (look here).
Some trials were already rethinking their participation, but Applegate insists Wake Forest’s decision was “totally disconnected” from the safety debate and “didn’t have to do with the drug,” and that the withdrawal occurred because it was struggling to find subjects. For its part, Glaxo continues to maintain Avandia is safe and adds that patients sign informed-consent forms describing potential side effects.
However, Glaxo opened dozens of new sites overseas in April, including many in developing nations, such as Pakistan, India, Mexico, Latvia and Columbia, according to ClinicalTrials.gov (see here). Sidney Wolfe of Public Citizen, which wants the trial halted, calls it “particularly troublesome” that Glaxo had added so many sites in countries where patients may not be aware of Avandia safety questions.