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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This is outrageous. We need to elect a government that will responsibly overhaul the FDA and makes it into an agency that protects the health of our citizens rather than the profits of Big Pharma.
The real problem with generic drugs is in their manufacture–filthy plants, little oversight. I suggest you check out this:
https://www.peoplespharmacy.com/articles/show-1169-what-are-the-problems-with-generic-drugs/
Investigative journalist Katherine Eban spent years looking into the generic drug industry. With more than 80 percent of the active pharmaceutical ingredients now coming from countries such as China and India, this was a big task. What she uncovered was a shocking story of incompetence, fraud and coverups among companies making generic drugs.
Great… I was just switched to Valsartan from Lisinopril by my GP. I discussed it with my cardiologist and was told that it was a good switch. Thankfully, my doctors know that I have the knowledge and will switch me if I request it.
The trouble is, what to switch to?
Last Autumn, I think I read on here that the manufacturer had allowed some carcinogen into lisinopril blood pressure medicine. I think it was in the 10/12.5 dose pill. I was on the 20/25 dose so I was not too worried. Now I am back on 10/12.5 and am very worried. Can you give me more info on this or a link I can search for myself??
We know this for certain–we and many more were unwitting guinea pigs for the Lyme Disease vaccine! It ended up being pulled from the market but not before a lot of harm was done.
One of these generic Losartan Potassium Tab 25 mg pills accidentally dissolved in my mouth immediately while taking it with low sugar Gatorade. It tasted like poison. It also took a few hours for the taste to leave my mouth even after brushing my teeth.
What happened to “Do no harm” As long as the pharmaceutical industry is funding the medical schools and has its greedy hands in everything this will never change. Also, don’t forget about the lobbyists. It is a crying shame!!!!
The FDA needs to be dismantled. They have become a proliferation of profiteering at the public’s expense. Rather than have appointees who OK drugs made with dangerous substances (and the drug companies line the FDA’s pockets to get the drugs approved) the positions should be VOTED UPON BY THE PUBLIC.
These & other drugs were ALL created to make Big Pharma profits—PERIOD!!!! Meds were used instead of using any toxic names for their toxic drugs. Medication is a misnomer!!!!
Human Beings are allowing themselves to be fracked. Allowing themselves…
I am a Nurse Practitioner and I work with women worried about breast cancer or do not want their cancer to return.
In my new book Protect Your Breasts, I have a chapter on environmental toxins and their role in increasing your breast cancer risk. Having dangerous chemicals added to prescription drugs should be banned and pharmaceutical companies sued. Remember “Do No Harm” is the oath that medical practitioners take.
Drugs need to be safe!!
I am 76 years old and have known first hand since I was 10 years old that the FDA was sold out to the rich elites by the 1950’s. Those SOBs hired the FDA to go through the country and eradicate the mom and pop butcher shops in favor of Armor Meat Packing company. Then they removed the one company that produced a medication that stopped my allergy to poison ivy and poison oak.
This country is totally owned by the rich — not the rest of us. It will continue to be owned by the rich until enough of us band together and get an open season declared on those rich shits so we start penning them up away from the rest of us or just killing them outright. I figure the odds of that happening at about a million to one against. But I keep hoping.
The FDA, Felony Drug Agency, needs to be dissolved. Big Pharma indicted and broken up, lobbying outlawed and people need to wake up and stop taking every prescription you get from pill pushing, paid to push doctors. The side effects outweigh the benefit in most cases. Stop being a mindless zombie! If most people would change diet and lifestyle they would regain their health.
Big Pharma owns the FDA and all Politicians in DC.
How about if the FDA does their job. Make it a requirement that before a drug can be sold to the public it has to be inspected by a an independent lab for quality and side effects. See if it matches with what the drug company sent as proof.
It is seriously broken, this industry, and puts us all in danger, but how is it gonna get fixed?? What a horrid and scarey mix! Who can help!!?? I have a no clue but if we dont get it, that really scares me! God help us all!
Wonderful article. Very corrupt system. Greed greed greed.
Very good article. Corrupt agency. Greed greed greed
I briefly worked for a pharmaceutical company, my husband retired from one. We know the shenanigans that go on. I don’t trust anything that says, “FDA-approved.” I have had doctors in the past try to discourage me from taking any supplements because they are not FDA-approved. I am suspicious of anything that is.
Depending on the manufacturer, Losartan has also been contaminated. Neither my doctor, the clinic where she is, nor my pharmacist alerted me that the company that made my pills was one of the bad guys. Let’s not forget that China and India are primary providers of the substances for our RX’s and also produce them. I had to twist my pharmacists arm to find out how to get a safe producer for this medication.
I don’t like the whole way this was handled. Apparently they now think that the problem goes back a few years. That means that to prevent a heart attack, I have been exposing my body to toxins that leave me at a higher risk of getting cancer, which isn’t likely given my genetic makeup.
Swell. Don’t forget, many folks at the top at the FDA were former drug company administrators. The fox is running the hen house!
As long as Mitch and his corporate loving minions are in power change is hopeless. Changing the face of the Senate and House to reflect the safety and best interest of Americans is the only way out. Most loyal Trump voters are I find sadly uninformed. They cannot clearly defend his policies other than immigration and the economy. Public safety is only an afterthought and the cuts and means to test new drugs is almost non existant. If only the average Republican knew????? PS I am an independent voter.
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