By Kristina Fiore, Staff Writer, MedPage Today
Published: March 27, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Cancer drugs rushed to the market via the FDA’s accelerated approval process often languish in confirmatory trials, agency researchers say.
Out of 47 indications granted fast-track status, benefits have not yet been confirmed in 21, mostly because trials are ongoing, according to John R. Johnson, MD, of the FDA’s oncology drugs office, and colleagues.
“Lack of due diligence in conducting confirmatory trials is a serious concern that has threatened the continuation of the accelerated approval process,” they wrote online in the Journal of the National Cancer Institute.
They noted that the Food, Drug, and Cosmetic Act of 2007 gives the FDA authority to levy penalties of up to $10 million on pharmaceutical companies for not completing trials for fast-tracked drugs quickly enough.
The accelerated approval process was established in 1992 for drugs that seemed more beneficial than existing therapies for life-threatening diseases, largely motivated by the emergence of HIV/AIDS.
Accelerated approvals may be granted on the basis of surrogate endpoints such as disease-free survival or time to progression. But to keep the approval, sponsors must conduct confirmatory trials that document the drugs’ actual benefit for overall survival or other more patient-centered outcomes.
For their review, the FDA researchers looked at all of the oncology products fast-tracked between Dec. 11, 1992 and July 1, 2010.
A total of 35 products were fast-tracked for 47 new indications; for 26 indications, the benefits were ultimately confirmed.
The median time to official full approval following the accelerated approval was 3.9 years, and the mean time was 4.7 years, “which represents substantial time savings in terms of earlier availability of drugs to patients,” the researchers wrote.
The three longest stretches between accelerated approval and successful conversion to regular approval were 12.6 years, 9.7 years, and 8.1 years.
But the analysis found that the benefit had not been confirmed in 21 new indications.
For three drugs — amifostine, gemtuzumab ozogamicin, and gefitinib — trials were completed and they failed to show benefit.
The researchers noted that it took about 10 years to find that amifostine and gemtuzumab ozogomycin weren’t clinically beneficial.
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[Note from SaneVax: Gardasil was approved via the accelerated approval process even though a safe and effective means of preventing invasive cervical cancer already existed. Gardasil clinical trials also used a surrogate endpoint (a questionable surrogate endpoint, in our opinion). So, a new drug (vaccine) was approved when it did not qualify for fast-track approval — because of the nature of cervical cancer progression, it will take decades to prove whether it is effective or not. Meanwhile, healthy young women are injected with an unproven substance that may or may not do anything for them. Adverse events and deaths continue to be reported after vaccination. Worse than that, because the label says ‘vaccine’ the manufacturer has virtually blanket immunity from liability. This is not acceptable.
When it comes to using any drugs, yes-vaccines are drugs, on healthy people – NO RISK IS ACCEPTABLE.]