More evidence that the drug approval process is completely broken.
A pharmacy recently alerted the FDA to the presence of a cancer-causing chemical in the popular blood-pressure drug valsartan, putting millions of patients at risk.
Incredibly, this isn’t even the first time dangerous chemicals have been found in this class of drugs. Generic forms of Valsartan have been recalled since 2018 when three other carcinogenic compounds were found in various versions of the drug.
In this current episode, a solvent called dimethylformamide (DMF) was discovered in valsartan pills still on the market in the US, which the FDA was recommending as an alternative to recalled versions. The World Health Organization classifies DMF as a “probable carcinogen.”
Note that the FDA allows drugs to contain small amounts of DMF. That’s right—the agency charged with protecting public health allows drug manufacturers to put a cancer-causing solvent in their pills.
The contamination of this heart drug highlights, among other things, the pitfalls of the drug manufacturing process. According to one expert, “Medicines are kind of like used cars: By the time you get it it’s already five or six years old, it’s touched hundreds of hands and it’s got 100,000 miles on it.” This puts the supposed safety of the medications that millions of Americans take—often more than one—in serious question.
Where is the FDA in all of this? As we know, the FDA doesn’t test the drugs it approves. It reviews the data that drug companies choose to submit, which is why the agency does not (and will not) detect the presence of cancer-causing chemicals in drugs.
Recall, too, the conflict of interest at the FDA. Through drug user fees, pharmaceutical companies pay millions of dollars to the FDA to approve drugs, making the agency financially beholden to the industry. As Dr. David Graham, a former senior drug safety researcher at the FDA, said: “As currently configured, the FDA is not able to adequately protect the American public. It’s more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent.”
There is an irony here. When it comes to dietary supplements, compounded medicine, and other natural health modalities, we’re told by the FDA that more regulations bringing natural products through a drug-like pre-approval system will better protect the public; compounded medicines are viewed skeptically by the FDA because they do not go through the agency’s drug approval process. The example of Valsartan, and the many other examples of dangerous drugs getting approved and subsequently killing thousands of people, should put to rest notions that FDA approval ensures safety. It appears that agency moves to regulate natural products have more to do with eliminating competition for drugs than with safeguarding public health.
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Your article has false truths and inaccuracies. Medical device manufacturers and drug manufacturers have specific testing to submit to FDA, including the protocols. FDA can request specific testing and audit the manufacture and facilities. There are also specific standards they are required to follow. Please do not distribute false information to the public. There are companies that “omit” information to the FDA” and once FDA catches them there are mechanisms in place for violations to be addressed.
Please use petitions,call ins to congress and any means to achieve our goals..
If this and other of your many abuses continue, then that which you have meted out to others shall soon in turn be meted out to you: a taste of your own toxic medicine.
Do what we’re paying you to do and PROTECT us from these carcinogens!!
Prevent drugs with carcinogens from going on the market.
The FDA acts in a manner that is totally acceptable to its true identity – a wholly-owned subsidiary of Big Pharma!!!
Well it’s what I have been saying to my patients and everyone I can that you do not mess with
the cash cow. The FDA has no real concerns for Americans except when there a major recall
on food. That allows the public to think they are watching out for them and it is a great tool for the FDA
all the other corrupt organizations to appear they are watching out for us.
I can only say live a life of prevention and you will not have to worry about drugs because
you body will not require them.
Hippocrates said it best “Let food be your medicine and medicine be your food.”
Thank you for letting me share.
Blessings, Dr. Yurick
The Language of the above article is RIGHT ON THE MARK . I am a Cytotechnologist , a laboratory technician who screens pap smears . We are mandated to utilize an instrument for screening pap smears . It has an alarming tendency to ignore abnormal cells if present in large clusters . It is in place because it makes money , lots of it . I believe I was fired from my job because I reported it missing 7 clusters of Uterine Cancer cells while the zeroed in on a air bubble and globs of mucous . I am afraid of mentioning the name of the device for fear of retaliation . Apparently , The FDA or the Center for Devices and Radiological Health ( CDRH ) , never even looked at the device . For more info please see the Facebook sites — FDA : Can We Trust Them , , , or Save The Pap Smears .
Is it the fatal drug administration?
You all really need to pay attention and do your job and stop allowing all these dangerous drugs through that have all manner of harmful and toxic ingredients in them. Stop allowing yourselves to be bought-out by Big Pharma. The FDA was created for the protection of the people and not for big pay-offs to help kill us, so do your job correctly and have a little integrity and more ethical values.
No carcinogens in medicines, counterproductive!
We have carcinogens in our water, food and now our medicine. I guess that we need to fix the system or destroy the system that we have and go back to natural medicine.
I have maintained for several years now that the FDA was in big Pharma’s pocket. This article has confirmed my belief. To think so many people still believe the FDA is there with our best interest at heart and to protect us! What a joke. So they are being paid to approve drugs. Kickbacks, bribery, and a huge conflict of interest. Shame on the FDA. It’s time to drain the big Pharma swamp along with the FDA.
This is a test comment
This is so unfortunate and negligent!!
Fda is corrupt. It does not care about people. Only power. And money are the fdas targets
I suspect there are like problems with supplements, particularly if the materials are sourced or they are manufactured in China, India or other countries where oversight is lacking.
I have a “health food store” and the suppliers I deal with do quality checks on every shipment of bulk herbs that come in. If there is anything that does not meet strict standards it is refused. That would explain that every now & then they are out of stock of a particular product. They also have regular analysis of products stocked (before it was even required by gov.) of content, purity, amount as stated on bottle, contaminates, etc. If anything does not meet standards it is pulled. To my knowledge stocked supply only had one incident where another manufacturer was making their “softgels” & the ingredients were not as labeled. They did not use that company again & got equipment to make their own. That was many years ago. They notified their Retailers immediately. Some of your low cost supplement companies may not have as strict qualifications.
Maybe it’s time we looked into oxygen therapy and other alternatives instead of “asking your doctor if the next drug approved by the FDA is right for you”.
If the FDA is supposed to be making sure that drugs are safe, why aren’t they doing their job? Many drugs are killing people & to allow a carcinogen in prescriptions is not making us safe. It is time to get our prescriptions safe or do away with the FDA all together. If our drugs aren’t safe, what are they doing?
I THOUGHT HITLER WAS DEAD
TIME TO CHANGE THE FDA, AND STOP THE KILLING.
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I have known for years about the FDA and their swinging door of employees working for them and big pharma. Most drugs are counter productive to good health, and the FDA is big pharma’s guard dog against natural supplements and meds that actually work. Personal example–my husband is permanently disabled due to statin drugs and the worst adverse side effect from it–rhabdomyalosis. It took two years after the reaction that caused his collapse at work for him to tear all of the tissues and disks in his spine from C-1 all the way down to his right knee in one move–less than 10 seconds. Now he lives in constant pain, but the medical industry doesn’t want to help–wven though their diagnosis was lifelong pain management–they want him to try invasive procedures and more new drugs! Get these criminals out of our govt, and give the people what they truly deserve–an FDA that is staffed by people that actually care and can’t be bought for any amount of money!