We used to tremendous confidence in the FDA. When we started writing about pharmaceuticals nearly 50 years ago, the agency was highly respected. It had mostly protected American children from the thalidomide disaster that devastated Europe. The agency seemed committed to protecting citizens from impure and unsafe drugs. And pharmaceutical manufacturers were forced to jump over high hurdles to prove that their medications helped patients more than they harmed them. Has all that changed? Is the FDA shooting the messenger that brings bad news about contamination with carcinogenic chemicals discovered in medicines and body care products?
Consumer Reports Investigates the FDA’s Investigation:
An article in Consumer Reports (March 31, 2022) asks an interesting question:
“A Tiny Lab Found Benzene in Sunscreen and Hand Sanitizer. Why Did the FDA Go After It?
“The agency inspected Valisure after its damning findings led to major recalls. Now, consumer claims of harm against implicated companies could be derailed.”
Do you remember when some very popular blood pressure medications (ARBs) were found to be contaminated with probable carcinogens called nitrosamines? We wrote about this extensively in 2019. We also wrote about a pharmacy in New Haven, Connecticut called Valisure. It was testing every batch of every drug it sold for impurities.
Valisure discovered contaminants in the blood pressure drug valsartan. Then it discovered that the heartburn drug ranitidine (Zantac) had the nitrosamine carcinogen NDMA at scary levels. The lab also reported that some formulations of metformin, a popular diabetes medicine, were also contaminated with nitrosamines.
Eventually, Valisure discovered the cancer-causing chemical benzene in hand sanitizers and many body care products. Why didn’t the FDA discover all these problems itself? Some folks are losing confidence in the FDA and its ability to protect the public. Why in the world would the feds go after a small company that was trying to protect the public from carcinogens? Does this sound a bit like the David and Goliath Story? Read on to learn more.
A Brief History Lesson:
The FDA became a watchdog instead of a lapdog because of a 1937 tragedy. That year a popular pre-penicillin antibiotic called Elixir Sulfanilamide had killed more than 100 people instead of curing their infections. The sulfa syrup had been formulated with a toxic solvent, diethylene glycol (DEG).
The powdered sulfa drug was hard to dissolve in liquid. Because doctors sometimes prescribed this medicine for children, the pharmaceutical manufacturer (S. E. Massengill) needed a way to get it into solution. The head pharmacist at the company tested the sweet-tasting DEG liquid together with some raspberry flavoring. This got the powdered medicine into solution. Success!
But when children consumed it, they developed nausea, vomiting, kidney failure and many died. In those days, manufacturers did not have to prove that their products were safe. The company accepted no responsibility for the tragedy, though the head pharmacist committed suicide.
Congress passed the original Food and Drugs Act on June 30, 1906. This law forbids selling adulterated drugs, drinks or foods across state lines. The Elixir of Sulfanilamide scandal led Congress to pass legislation that would empower the FDA to keep unsafe drugs off the market. That’s why the agency frequently brags that American drugs are safe and effective thanks to its vigilance.
Why We Are Losing Confidence in the FDA:
The Federal Food, Drug and Cosmetic Act of 1938 gave the FDA teeth to protect American citizens from contaminated and/or unsafe drugs. It was an advance over the 1906 Pure Food and Drugs Act. Companies were supposed to submit data to the agency proving their products were not only pure but safe! It also authorized factory inspections, which the FDA conducts to this day.
According to its mission statement:
“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”
Is the FDA Living Up to its Mission?
What happened to this mandate? Can you trust the FDA to make sure your over-the-counter and prescription products are both pure and safe? The answer appears to be no. I have lost confidence in the FDA.
We have received thousands of complaints about generic drug quality over the last two decades. We notified the agency in 2007 that readers of our column were experiencing problems with the generic antidepressant bupropion (Wellbutrin).
Initially, the FDA was dismissive and blamed patients for psychosomatic reactions. Five years later, however, an investigation demonstrated that some generic formulations were not equal to the brand name.The agency encouraged the companies involved to recall the defective bupropion products.
In theory, the problem was fixed. But a decade later we continue to receive complaints about generic bupropion. Some people have become suicidal after being switched to a generic that did not work for them. We have notified the agency of these problems. So far, there has been no official response about testing or quality.
Why Hasn’t the FDA Discovered Contamination or Poor Quality?
You might expect that the Food and Drug Administration would be monitoring drugs and health-related consumer products. If the agency found any that were contaminated, you would imagine it would immediately get them off the market.
Unfortunately, that is not how things work today. Instead of a strong watchdog, the FDA has apparently become a paper tiger. That is to say, it is slow to detect problems and even slower to address them aggressively.
What is the Meaning of Pure?
The Oxford English Dictionary defines “pure” as:
“not mixed or adulterated with any other substance or material.”
“without any extraneous and unnecessary elements.”
“free of any contamination.”
Seemingly, the FDA does not adhere to such a definition when it comes to popular over-the-counter products. And there have been way to many contaminated prescription drugs for our taste over the last few years. What ever happened to the “Pure Food and Drug Act” of 1906?
The Benzene Bust:
Take the carcinogen benzene, for example. It has been found in some hand sanitizers, sunscreens, antiperspirants, deodorants and antifungal athlete’s foot sprays. The FDA did not discover most of the contamination on its own. Valisure, has filed Citizens’ Petitions detailing its findings.
Why is benzene bad? According to the National Cancer Institute:
“Exposure to benzene increases the risk of developing leukemia and other blood disorders.”
The CDC states:
- “Benzene is widely used in the United States. It ranks in the top 20 chemicals for production volume.
- Some industries use benzene to make other chemicals that are used to make plastics, resins, and nylon and synthetic fibers. Benzene is also used to make some types of lubricants, rubbers, dyes, detergents, drugs, and pesticides.”
“The major effect of benzene from long-term exposure is on the blood. (Long-term exposure means exposure of a year or more.) Benzene causes harmful effects on the bone marrow and can cause a decrease in red blood cells, leading to anemia. It can also cause excessive bleeding and can affect the immune system, increasing the chance for infection.
“The Department of Health and Human Services (DHHS) has determined that benzene causes cancer in humans. Long-term exposure to high levels of benzene in the air can cause leukemia, cancer of the blood-forming organs.”
Why Didn’t the FDA Discover Benzene?
Our antiperspirants, deodorants, antifungal athlete’s foot sprays, sunscreens and hand sanitizers should not have benzene, right? If something is “pure” it should not have carcinogens as added ingredients. In its simplest definition, pure should mean “free of any contaminants.” That means NO benzene!
Historically, it would appear that the FDA has not been looking for things like benzene or nitrosamines. If Valisure had not uncovered nitrosamine contaminants in the popular heartburn medicine ranitidine (Zantac), we suspect that it would still be on the market.
Is the FDA Shooting the Messenger?
None of us like to learn that we might have made a mistake. Do you remember the FDA’s mission statement?
“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs…”
The agency also maintains that it ensures the safety of our cosmetics. Benzene is not supposed to be in body care products like deodorants, antiperspirants and sunscreens or hand sanitizers. And yet the FDA seemed completely surprised when Valisure uncovered the contamination in such products.
According to the investigative article from Consumer Reports (March 31, 2022), “…companies have now recalled more than 25 million products from the market” thanks in large measure to the Valisure testing program.
You might think the FDA would be grateful for assistance in detecting hazards to the public health. After all, the agency has surprisingly little capacity to do this kind of testing itself. Instead, the FDA sent inspectors to investigate Valisure.
The FDA does not appear to be questioning the findings of this independent lab. Instead the agency is asking whether the laboratory has jumped through the appropriate bureaucratic hoops.
Valisure is located in Congresswoman Rosa DeLauro’s district. She told Consumer Reports:
“I fear, whether deliberate or not, FDA is in the act of shooting the messenger.”
We think the FDA should be paying more attention to the message and getting carcinogens out of our drug supply.
The Voluntary Recall Boondoggle:
When the FDA learns that a product is contaminated with a dangerous ingredient such as benzene, you might expect the agency to immediately remove it from the market. Surprisingly, the agency does not appear to have the authority or the willingness to do so.
Instead, the FDA alerts the public to products that may be contaminated through an announcement on its website. For example, you can find a post titled “FDA updates on hand sanitizers consumers should not use.” There are actually 27 pages with 266 entries in this web post.
Most consumers don’t check the FDA website, though. They just assume that the agency is protecting them.
We were surprised to learn that the FDA does not have the authority to force a company to recall its over-the-counter products. Such recalls are made on a voluntary basis. If a company chooses not to remove its products, it doesn’t have to.
Congresswoman Rosa DeLauro has reintroduced legislation that would give the FDA authority to force problem products off the market. The “Recall Unsafe Drugs Act” does not seem to have a lot of support with her colleagues or even at the FDA. It would give the FDA mandatory recall authority over products that cause serious health consequences or death. If you think this is a good idea, please let your Congressperson know.
Drug Approval Has Changed!
It’s not just carcinogens in drugs that worries us. We have become alarmed at the way the FDA approves new medications. In the “good old days,” a drug company that wanted the agency to approve its medicine needed to present significant data from two convincing clinical trials. These needed to show that the product was reliably better than an inert but indistinguishable placebo product.
A decision by the FDA has undermined its credibility. The agency approved aducanumab (Aduhelm) to treat Alzheimer disease not because it addresses the symptoms or slows a victim’s slide into stupor but because it reduces a marker in the brain. In fact, as the FDA itself explained, it used the accelerated approval pathway because that permits approval based on biochemical measurements instead of clinical improvement. They call this a “surrogate endpoint.”
Is Beta-Amyloid A Boondoggle?
In this case, the marker is beta-amyloid, a tiny piece of a protein found in the brain. No one doubts that the brains of people with Alzheimer disease are full of plaques with bits of beta-amyloid stuck together. The hypothesis is that these plaques cause the disease. But this idea remains unproven and controversial.
Aduhelm does reduce beta-amyloid plaques in the brain. No one disputes that. The question is whether this will make an important difference for patients and their families.
Surrogate Endpoints and Confidence in the FDA?
Changing a surrogate endpoint is not the same as offering clinical improvement. Dr. Matthew Schrag is a neurologist who does research at Vanderbilt University Medical Center. He offered this analogy in the Washington Post (July 16, 2021):
“Even if amyloid does cause Alzheimer’s disease, it does not necessarily mean you can cure the disease by removing it. If someone came to the emergency room with a stab wound, just removing the knife wouldn’t cure them either.”
Surrogate Endpoints and the Heart:
This is not the first time the FDA has approved a drug based on a surrogate endpoint. Alirocumab (Praluent) and evolocumab (Repatha) are cholesterol-lowering medications. When added to statins, they dramatically reduce “bad” LDL cholesterol. FDA approved these medications based on cholesterol measurements.
The understanding was that the companies would conduct clinical trials to see if they also prevent heart attacks and death. In a review, these drugs lowered LDL cholesterol successfully, but the reduction in death from coronary heart disease was not statistically significant (Journal of Clinical Medicine, Apr. 5, 2021).
Do Cancer Drug Approvals Create Confidence in the FDA?
FDA has also used accelerated approval for cancer drugs. A number of drugs have been approved based on their ability to shrink tumors. That seems like a good thing, but it doesn’t ensure a longer, healthier life.
A commentary in JAMA Internal Medicine (May 28, 2019) noted:
“Response rate is not itself a meaningful clinical outcome; the size of a tumor does not matter if patients’ lives are not extended or if their quality of life is not improved.”
You can read more about why we have lost confidence in the FDA when it comes to new cancer drugs at this link:
FDA’s Accelerated Approval of Cancer Drugs A Big Bust
Patients with hard-to-treat cancers are desperate for new and better cancer drugs. The FDA’s accelerated approval process is supposed to do that. Does it?
Is the FDA Gambling With Your Life?
I wrote an article in which I compared the surrogate end points the FDA loves so much with casino chips. How long would a casino stay in business if it didn’t give you money when you “cashed” in your chips? You know the answer to that question! About a nanosecond.
And yet drug companies can take your money for lowering cholesterol, reducing blood sugar or removing beta-amyloid from your brain without demonstrating any clinical benefit. In other words, the outcomes you actually care about (a healthier, longer life) do not have to be established to achieve FDA approval.
Here is a link to that article:
Do Faster FDA Drug Approvals Mean Greater Danger?
Do you trust the FDA to make wise decisions about drug safety and effectiveness? A new study in JAMA says that faster FDA drug approvals may not be better.
Everyone wants the latest, greatest treatment for Alzheimer disease, diabetes, cancer or heart disease. However, we need to be cautious about embracing drugs approved on the basis of surrogate endpoints. These medications, which are frequently extremely expensive, don’t necessarily improve patients’ lives.
What Readers Have to Say About Confidence in the FDA:
Rachel offers her perspective on Tylenol and the FDA:
“Medication, whether over the counter or prescription, has side effects. “Trust Tylenol” is a marketing slogan–nothing more. Sadly, people believe this advertising. My mother always said that each person should be his, or her, own watchdog. My father agreed with her.
“The People’s Pharmacy recently featured an article about whether or not we should trust the FDA. The FDA, the manufacturers of Tylenol and generic acetaminophen products have not done an adequate job of warning the public.”
Linda has also lost confidence in the FDA:
“As a retired Health and Welfare Manager for a national company with 40,000 medically insured employees, and over 36 years experience, I have said that the relationship between the FDA and pharmaceutical manufactures is a case of the fox guarding the henhouse.
“I’m one of those people who read about every side effect any drug is known to have, no matter how benign. I also listen to the TV ads. I lay the blame on the government’s approval to allow the drug companies to advertise their products. Advertising costs money, huge money. Follow the money.”
Marilyn thinks the FDA has lost credibility:
“I think it is terribly sad that the FDA would approve a drug that does not actually work and could bankrupt Medicare. They should be ashamed and obviously need new people with integrity to work for the FDA. Changes definitely need to be made.”
Theresa is a nurse who has lost confidence in the FDA:
“As a retired RN nursing supervisor, I would often reassure patients not to be concerned about their medication because it was FDA approved. Today, even before the current conflict re: Aduhelm, sadly, I would not be able to give the patients any reassurance at all.”
What do you think? Have you lost confidence in the FDA or do you think the agency is doing a great job? Please share your thoughts below in the comment section.
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And if you think the FDA should have the power to demand the removal of contaminated products from drugstore shelves, please let your senators and representatives know that they should support Congresswoman DeLauro’s initiative to recall unsafe drugs.