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liveonearthMy notes are behind the cut. These ladies review some recent FDA approvals and critique the process. The upshot is that the FDA is fast-tracking drugs without following their own rules regarding the supposedly scientific and independent review process. My take: Don't Use New RX drugs until they've been on the market at least 10 years. Otherwise YOU are part of the longterm followup studies that they aren't doing before approval.
SOURCE
http://healthaffairs.org/blog/2013/01/25/antibiotics-when-science-and-wishful-thinking-collide/
Antibiotics: When Science And Wishful Thinking Collide
by Diana Zuckerman and Jennifer Yttri
January 25th, 2013
Antibiotic resistance
major concern
tremendous pressure on the Food and Drug Administration (FDA) to “do something” about it
FDA approving drugs that are likely to do more harm than good
FDA advisory committees are supposed to provide independent advice
recent meetings cause us to ask if the advice is scientific or independent
TUBERCULOSIS DRUG: BEDAQUILINE/SIRTURO
newly approved, reviewed 11/28/12 by Anti-Infective Drugs Advisory Committee
first new TB medication in 40 years, specifically intended to tx multidrug-resistant tuberculosis (TB)
review process was expedited so the clinical trial wasn't done yet
approved in spite of data showing a 10% higher death rate for pts on the new drug compared to the usual standard of care, and survival gap increased over time
manufacturer: Janssen Therapeutics downplayed the negative finding and was allowed an exception to normal procedure in order to submit data from a long-term followup study that didn't look so bad
decision was made without regular independent review process
ANOTHER DRUG
telavancin, an antibiotic that is already on the market by the name of Vibativ
For the tx of complicated skin infections
AE: birth defects in animals, kidney toxicity in humans
many safer drugs available
has twice before been denied approval by the FDA for treating pneumonia
review committee ok'd it based on hypotheticals
the sickest patients (DM, heart/kidney fail) most likely to die w telavancin vs vancomycin
COMMENTARY
problem with the FDA’s accelerated approval process: not science-based
policies regarding the analyses of safety data are inadequate
desire to push new drugs through the pipeline is causing oversights
we shouldn't sacrifice science for speed
IMPORTANT QUESTIONS
Why bother to spend taxpayer money reviewing drugs with such poor evidence of efficacy?
Can the fda not make decisions without advisory committees?
Will the FDA permit data from other sources besides the company trying to get the drug approved?
Why is the FDA approving drugs that aren't proven safe and effective?
Why is the FDA approving drugs it has previously passed on?
BACK A YEAR WHEN YASMIN WAS APPROVED
birth control pill
well-respected former FDA Commissioner, Dr. David Kessler, had written a report that documented that Bayer covered up data describing the high risk of venous thromboembolisms (VTEs) among Yasmin patients
BUT FDA would not allow Kessler’s report to be shared with the committee or discussed during public hearing because it was introduced too late
PNEUMONIA DRUGS CONSIDERED
last two drugs considered for ventilator-acquired pneumonia
doripenem and tigecycline-->incr mortality
COMMENTARY
process of developing/approving abx has some indefensible scientific practices
drugs are assigned to priority review before Phase II & III safety studies on humans are completed
**mortality is no longer considered an important outcome by the FDA
WHAT? HOW CAN THIS BE
**FDA supports studies of drug efficacy based on test tube data rather than patient-centered outcomes, such as survival and better quality of life
no fair testing risky new therapies on humans too fast
INCENTIVES TO DRUG COMPANIES THANKS TO CONGRESS
new law-->generous incentives for companies to develop new antimicrobial drugs
market exclusivity extended five more years
four drugs have already been given QIDP (Qualified Infectious Disease Products) status
Another new regulation is being considered
would alter review process, permit "limited approval" for drugs using another expedited process
fast tracking is dangerous
FDA guidelines need to do more to reduce the overuse of antibiotics
use of older antimicrobials (approved without appropriate studies)-->resistance, mortality
drugs are likely to be obsolete before their patent exclusivity expires under QIDP
incentives are "restricting other companies from generating better drugs while approving those that have not been proven as effective or safe."
SOURCE
http://healthaffairs.org/blog/2013/01/25/antibiotics-when-science-and-wishful-thinking-collide/
Antibiotics: When Science And Wishful Thinking Collide
by Diana Zuckerman and Jennifer Yttri
January 25th, 2013
Antibiotic resistance
major concern
tremendous pressure on the Food and Drug Administration (FDA) to “do something” about it
FDA approving drugs that are likely to do more harm than good
FDA advisory committees are supposed to provide independent advice
recent meetings cause us to ask if the advice is scientific or independent
TUBERCULOSIS DRUG: BEDAQUILINE/SIRTURO
newly approved, reviewed 11/28/12 by Anti-Infective Drugs Advisory Committee
first new TB medication in 40 years, specifically intended to tx multidrug-resistant tuberculosis (TB)
review process was expedited so the clinical trial wasn't done yet
approved in spite of data showing a 10% higher death rate for pts on the new drug compared to the usual standard of care, and survival gap increased over time
manufacturer: Janssen Therapeutics downplayed the negative finding and was allowed an exception to normal procedure in order to submit data from a long-term followup study that didn't look so bad
decision was made without regular independent review process
ANOTHER DRUG
telavancin, an antibiotic that is already on the market by the name of Vibativ
For the tx of complicated skin infections
AE: birth defects in animals, kidney toxicity in humans
many safer drugs available
has twice before been denied approval by the FDA for treating pneumonia
review committee ok'd it based on hypotheticals
the sickest patients (DM, heart/kidney fail) most likely to die w telavancin vs vancomycin
COMMENTARY
problem with the FDA’s accelerated approval process: not science-based
policies regarding the analyses of safety data are inadequate
desire to push new drugs through the pipeline is causing oversights
we shouldn't sacrifice science for speed
IMPORTANT QUESTIONS
Why bother to spend taxpayer money reviewing drugs with such poor evidence of efficacy?
Can the fda not make decisions without advisory committees?
Will the FDA permit data from other sources besides the company trying to get the drug approved?
Why is the FDA approving drugs that aren't proven safe and effective?
Why is the FDA approving drugs it has previously passed on?
BACK A YEAR WHEN YASMIN WAS APPROVED
birth control pill
well-respected former FDA Commissioner, Dr. David Kessler, had written a report that documented that Bayer covered up data describing the high risk of venous thromboembolisms (VTEs) among Yasmin patients
BUT FDA would not allow Kessler’s report to be shared with the committee or discussed during public hearing because it was introduced too late
PNEUMONIA DRUGS CONSIDERED
last two drugs considered for ventilator-acquired pneumonia
doripenem and tigecycline-->incr mortality
COMMENTARY
process of developing/approving abx has some indefensible scientific practices
drugs are assigned to priority review before Phase II & III safety studies on humans are completed
**mortality is no longer considered an important outcome by the FDA
WHAT? HOW CAN THIS BE
**FDA supports studies of drug efficacy based on test tube data rather than patient-centered outcomes, such as survival and better quality of life
no fair testing risky new therapies on humans too fast
INCENTIVES TO DRUG COMPANIES THANKS TO CONGRESS
new law-->generous incentives for companies to develop new antimicrobial drugs
market exclusivity extended five more years
four drugs have already been given QIDP (Qualified Infectious Disease Products) status
Another new regulation is being considered
would alter review process, permit "limited approval" for drugs using another expedited process
fast tracking is dangerous
FDA guidelines need to do more to reduce the overuse of antibiotics
use of older antimicrobials (approved without appropriate studies)-->resistance, mortality
drugs are likely to be obsolete before their patent exclusivity expires under QIDP
incentives are "restricting other companies from generating better drugs while approving those that have not been proven as effective or safe."
