Journal of the American Medical Association: Over 30% of All ‘FDA-Approved’ Drugs Have Grave & Deadly Side Effects
A study from The Journal of the American Medical Association has exposed safety issues occurring in over 30% of FDA-approved drugs between 2001 and 2010.
Matt Agorist February 4, 2018
Close to one-third of drugs approved by the FDA are found to have safety problems, according to a research report from The Journal of the American Medical Association.
JAMA’s report stated that these safety issues, known as “postmarket safety events,” are “common after FDA approval, highlighting the importance of continuous monitoring of the safety of novel therapeutics throughout their life cycle.”
Every single day in the United States, 1,000 people are treated in emergency departments for a single FDA-approved drugopioids. Opioid drug overdoses now kill more people annually than the number of Americans who died in the Vietnam war.
However, it’s not only opioids. Acetaminophen overdose is actually the leading cause for calls to Poison Control Centers across the USmore than 100,000 instances per yearand, each year, is responsible for: More than 56,000 emergency room visits. 2,600 hospitalizations. An estimated 458 deaths due to acute liver failure.
According to some estimates, Antidepressants, which are handed out like candy with the FDA’s blessing, causeover 40,000 deaths per year.
The death toll from the three aforementioned medications tops 100,000 annually, yet still, there are countless others.
The study sought to identify the “frequency of postmarket safety events” of FDA-approved drugs. It revealed that 222 “novel therapeutics” were approved by the FDA between 2001 and 2010. Out of those 222 FDA-approved products, there were 123 safety issues later found in 71, or 32 percent, of the approved drugs. Actions taken for the 71 drugs included withdrawal of the substance, new safety announcements highlighting discovered risks, and issuing “black box” warnings.
These safety problems “were more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval,” according to the report.
Products that completed speedy reviews were not necessarily as likely to see safety complications down the road. However, drugs that were approved by the FDA near the review deadline were more likely to reveal future problems.
“The authors interpreted this as suggesting that if drugs have strong pre-market safety data and can sail through their reviews, it may be a good indicator of their overall safety. Whereas, when drugs get hung up in their reviews, possibly because regulators are trying to parse weak or questionable pre-market safety data, it may be a red flag that there are post-market safety problems to come,” noted Ars Technica.
Another problem highlighted in the study was drugs approved by the FDA via “accelerated” reviews also ending up with safety issues.
The public would likely and see tremendous benefit, and a decline in detrimental complications, with more thorough and consistent follow-up reviews of approved drugs. Legislators have continuously pressed the FDA to speed up their drug approval process while paying far less attention to the long-term safety of these drugs once available to the public.
In investigative journalist Ben Swann’s 2016 Truth In Media episode examining the relationship between the FDA and the pharmaceutical industry, Swann spoke with Emory University Professor Doug Bremner about the issues with the FDA’s followup on approved drugs. Bremner told Swann that Congress limited the budget of the FDA in past years, “but they’ve also demanded that they increase the speed in which they approve drugs. So the number of people working on new drug approval has been increasing at the expense of those who are supposed to be watching the drugs coming onto the market.”
The 21st Century Cures Act, passed by former President Barack Obama in December 2016, aimed in part to further speed up the drug approval process. The Act allows the FDA to include “real world” evidence to approve drugs, “the kind provided by patients using the medication in a real-world setting as opposed to carefully designed and controlled trials,” according to a report published by the Dallas Morning News.
This could potentially lead drug companies to move away from opting for long-established clinical trials. Dr. Giuseppe Giaccone, the associate director for clinical research at Georgetown University, told the paper that this is “pretty bad for the FDA and very bad for patients, but it’s good for drug companies” and that it allows drug companies “more freedom to do whatever they like.”
Article posted with permission from The Free Thought Project
Don't forget to Like Freedom Outpost on Facebook, Google Plus, & Twitter. You can also get Freedom Outpost delivered to your Amazon Kindle device here.
Close to one-third of drugs approved by the FDA are found to have safety problems, according to a research report from The Journal of the American Medical Association.
JAMA’s report stated that these safety issues, known as “postmarket safety events,” are “common after FDA approval, highlighting the importance of continuous monitoring of the safety of novel therapeutics throughout their life cycle.”
Every single day in the United States, 1,000 people are treated in emergency departments for a single FDA-approved drugopioids. Opioid drug overdoses now kill more people annually than the number of Americans who died in the Vietnam war.
However, it’s not only opioids. Acetaminophen overdose is actually the leading cause for calls to Poison Control Centers across the USmore than 100,000 instances per yearand, each year, is responsible for: More than 56,000 emergency room visits. 2,600 hospitalizations. An estimated 458 deaths due to acute liver failure.
According to some estimates, Antidepressants, which are handed out like candy with the FDA’s blessing, causeover 40,000 deaths per year.
The death toll from the three aforementioned medications tops 100,000 annually, yet still, there are countless others.
The study sought to identify the “frequency of postmarket safety events” of FDA-approved drugs. It revealed that 222 “novel therapeutics” were approved by the FDA between 2001 and 2010. Out of those 222 FDA-approved products, there were 123 safety issues later found in 71, or 32 percent, of the approved drugs. Actions taken for the 71 drugs included withdrawal of the substance, new safety announcements highlighting discovered risks, and issuing “black box” warnings.
These safety problems “were more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval,” according to the report.
Products that completed speedy reviews were not necessarily as likely to see safety complications down the road. However, drugs that were approved by the FDA near the review deadline were more likely to reveal future problems.
“The authors interpreted this as suggesting that if drugs have strong pre-market safety data and can sail through their reviews, it may be a good indicator of their overall safety. Whereas, when drugs get hung up in their reviews, possibly because regulators are trying to parse weak or questionable pre-market safety data, it may be a red flag that there are post-market safety problems to come,” noted Ars Technica.
Another problem highlighted in the study was drugs approved by the FDA via “accelerated” reviews also ending up with safety issues.
The public would likely and see tremendous benefit, and a decline in detrimental complications, with more thorough and consistent follow-up reviews of approved drugs. Legislators have continuously pressed the FDA to speed up their drug approval process while paying far less attention to the long-term safety of these drugs once available to the public.
In investigative journalist Ben Swann’s 2016 Truth In Media episode examining the relationship between the FDA and the pharmaceutical industry, Swann spoke with Emory University Professor Doug Bremner about the issues with the FDA’s followup on approved drugs. Bremner told Swann that Congress limited the budget of the FDA in past years, “but they’ve also demanded that they increase the speed in which they approve drugs. So the number of people working on new drug approval has been increasing at the expense of those who are supposed to be watching the drugs coming onto the market.”
The 21st Century Cures Act, passed by former President Barack Obama in December 2016, aimed in part to further speed up the drug approval process. The Act allows the FDA to include “real world” evidence to approve drugs, “the kind provided by patients using the medication in a real-world setting as opposed to carefully designed and controlled trials,” according to a report published by the Dallas Morning News.
This could potentially lead drug companies to move away from opting for long-established clinical trials. Dr. Giuseppe Giaccone, the associate director for clinical research at Georgetown University, told the paper that this is “pretty bad for the FDA and very bad for patients, but it’s good for drug companies” and that it allows drug companies “more freedom to do whatever they like.”
Article posted with permission from The Free Thought Project
Don't forget to Like Freedom Outpost on Facebook, Google Plus, & Twitter. You can also get Freedom Outpost delivered to your Amazon Kindle device here.
About the Author Matt Agorist
Matt Agorist is an honorably discharged veteran of the USMC and former intelligence operator directly tasked by the NSA. This prior experience gives him unique insight into the world of government corruption and the American police state. Agorist has been an independent journalist for over a decade and has been featured on mainstream networks around the world. Agorist is also the Editor at Large at the Free Thought Project.
Comment of :Jackie Junti simply do not understand why anyone who has been informed about how to avoid all this *side effects* of Big PHARMA drugs continues to take these drugs. So many folks complain about the MONEY made by the dealers of ILLEGAL drugs but will go to the drug store and fill a prescription handing over their $$$ to the CHEMICAL DEALERS.
I've written tons of emails rants about how to PREVENT getting any of the virus or bacterial illnesses by eating and drinking according to the pH balance diet. The ONLY anti-biotic that has NO side effects is Colloidal Silver.
I realize that most folks are too lazy to change their diet or to even try using Colloidal Silver to see how it kills any bug that might get in your system (internal or external). I've used Colloidal Silver since the early 1990's as I became allergic to every one the medical guys tried to give to me. I changed to the pH balance way of eating and drinking in 2007 and haven't had even ONE Day sick with any virus or bacterial illness since then What kind of PROOF do you guys need to have to figure out this WORKS and it is much much less expensive as well as having NO SIDE EFFECTS. It really ticks me off to have friends or family say anything to me about having a cold or the flu. They will go get those poisonous flu shots that have little if any preventive action on the Flu. Or take Tamiflu that is killing kids right now.
If you continue to ignore this information then I hope you enjoy being sick because that is what you are saying - loud and clear - I want to get sick and pay big bucks to get sicker from the side effects... or maybe die and not have to deal with any of it again.
Jackie Juntti
Comment made by: Kathy Hawkins: Yup exactly.....NATURAL and I have sent much about this very thing many times and yes colloidal silver too....I also have silver facial cream, silver gel and lozenges for staying healthy.....all natural healing. I feel I waste my times sending things like this as nobody ever emails me back so I feel I am ignored.
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