Why Have I Lost Faith in the FDA?

I started writing about prescription drugs, home remedies and over-the-counter medications over 50 years ago in my first book, The People’s Pharmacy (St. Martin’s Press). Back then, I was a big fan of the FDA! In fact, I dedicated two of my early books to Dr. Jere Goyan: “The best damn Commissioner of the Food and Drug Administration this country has ever had” and “A visionary leader and champion of people’s right to drug information.” But I have lost faith in the FDA. After reading a recent letter to FDA Commissioner Robert Califf (Dec. 13, 2023), so has Congress! What went wrong?

House of Representatives Committee on Energy and Commerce (Dec. 13, 2023):

Here is part of what the House Committee on Energy and Commerce wrote to FDA Commissioner Rob Califf:

“Pursuant to Rules X and XI of the U.S. House of Representatives, the Committee is investigating the Food and Drug Administration’s (FDA) inspection program. On July 18, 2023, the Committee sent you an oversight request letter seeking information and documents relevant to this ongoing investigation. To date, the FDA has not provided any response to the Committee.

“Since our first letter to the FDA, it has come to light that the FDA ended its unannounced foreign inspection program because the agency believed it was an obstacle to deeper collaboration with India. The same reporting also alleges that the FDA undermined a Department of Defense initiative to independently test the quality of imported drugs used by the military out of fear that it would undermine the FDA’s credibility.

“Since July there have also been additional drug recalls from Indian manufacturers and plant closures in the United States. In August, Indian drug manufacturers, Alembic and Aurobindo Pharma, issued voluntary drug recalls citing quality and manufacturing deficiencies, respectively. Alembic recalled over 80,000 bottles of tobramycin, used to treat bacterial eye infections, due to “failed impurities/degradation specifications.” Aurobindo recalled rufinamide tablets used to treat seizure disorders. As you are aware, both companies have a history of drug recalls and quality control failures.

“In short, drug shortages plague our nation. The U.S. cannot afford additional disruptions to the drug supply chain that reduce the availability of essential medications and force doctors and patients to make difficult treatment decisions. Members of this Committee have repeatedly expressed concern regarding the effectiveness of the FDA’s foreign drug inspection program, including at two separate hearings this Congress before the Subcommittee on Oversight and Investigations and the Subcommittee on Health.”

Unanswered Questions:

The House has asked some pointed questions. I too would like answers to these critical queries! Here are just a few unanswered questions:

• “How many FDA inspectors are currently conducting foreign inspections?

• The FDA has noted there is a backlog in conducting foreign inspections. How large is the backlog and what progress has the FDA made in closing it?

• In the last 10 years, for each year, what percentage of FDA inspections of foreign facilities have been preannounced and what was the lead time given for each preannounced inspection?

• Explain in detail why the FDA ended unannounced inspection pilot programs conducted in India between 2014 to 2015.

• Has an FDA inspector ever been detained, arrested, or otherwise prevented from completing an inspection of a drug manufacturing facility in China? Other countries?

• Does the FDA plan to start an unannounced inspection program in China? If not, explain in detail why not.”

These are just some of the questions Congress has asked the Food and Drug Administration. The FDA has until January 5, 2024, to answer these and many other questions. If we get access to any of the answers we will let you know.

Why We Once Trusted the FDA:

There was a time when most health professionals trusted the FDA. If the agency approved a medication, physicians, pharmacists and nurses usually believed that it must have passed rigorous review.

In the “old days,” generic drugs were mostly made in the USA. The Food and Drug Administration regularly sent investigators to make unannounced visits to both brand and generic drug manufacturers.

These days, most of the active pharmaceutical ingredients (APIs) in our generic drugs come from abroad. The FDA apparently makes little, if any, effort to find out where the ingredients in those APIs come from. The FDA alerts foreign governments and manufacturers of upcoming visits many weeks (or months) in advance. In the US, such inspections are unannounced! The storage and shipping of foreign-made medications is not as well tracked and managed as we think it should be.

Before We Lost Faith in the FDA:

In its mission statement, the agency creates an image of protection:

“What We Do”

“FDA Mission”

“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs…”

A former FDA Commissioner, Dr. Scott Gottlieb, simplified the message in a Valentine’s Day Tweet:

“Some pills are red,

“Some pills are blue,

“All are safe and effective,

“If they undergo FDA review.”

This sounds excellent. “Safe and effective.” That is precisely what we all expect from our medicines. We suspect, however, that the FDA’s definitions of safe and effective are very different from how you and I define those terms.

The FDA’s Drug Approval Process:

The FDA has waffled on its strategy for approving new drugs. Here is a page titled:

Is It Really ‘FDA Approved’?

The agency states quite clearly that if a drug company wants the FDA to approve a pharmaceutical product it:

“…must demonstrate that its drug or biological product is safe and effective for the intended use…”

The average person might interpret the word safe to mean that a drug does not cause danger or harm. The Merriam-Webster dictionary describes the word safe as “HARMLESS” or “free from risk.”

The average person probably defines effective as a drug that works to produce a clear benefit. The Merriam-Webster dictionary describes the word effective as “producing a decided, decisive, or desired effect.”

The FDA Creates Confusion:

There is, however, another FDA web page titled:

“Development & Approval Process | Drugs”

Here’s where the FDA creates confusion. The agency states that:

“FDA approval of a drug means…the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.”

So, we have gone from “safe and effective” to “benefits outweigh risks.” I don’t know about you, but for me, that is a huge difference. It explains why there are drug commercials on television that list heart attacks, strokes, cancer and death as potential risks of advertised medications.

Such adverse reactions clearly do not meet a “safe” approval requirement. But if the FDA changes its standards for approval to “benefits outweigh known and potential risks,” there is a lot of room for interpretation. The FDA may say that the benefits of a drug to treat rheumatoid arthritis outweigh the risks of cancer, blood clots, life-threatening infections, heart attacks, strokes or death. And if a patient dies after taking said drug, the family has no recourse. It cannot sue a drug company because of an adverse drug reaction. Read more about the loophole that protects pharmaceutical companies from such litigation at this link.

One More Thing!

The FDA routinely approves drugs that work for a relatively small number of people. The dictionary may define effective as producing a “decided, decisive, or desired effect,” but the FDA just requires a medication to work a bit better than nothing (a placebo). That has become apparent with the FDA’s approval of two drugs for Alzheimer’s Disease.

An Investigation Reinforces My Lost Faith in the FDA:

A review by two congressional committees challenges the idea that the FDA only approves drugs that are safe and effective. This 18-month investigation concluded that the FDA’s approval of aducanumab (Aduhelm) for Alzheimer’s disease was “rife with irregularities.”

For one thing, the agency collaborated with the drug company Biogen in ways that violated standard protocols, practices and documentation. For another, serious questions about the drug’s effectiveness for improving the lives of patients with Alzheimer’s disease have not been resolved.

Representative Frank Pallone was chair of the House Energy and Commerce Committee that participated in the investigation. He described the findings:

“This report documents the atypical FDA review process and corporate greed that preceded FDA’s controversial decision to grant accelerated approval to Aduhelm. While we all support the search for new cures and treatments to address devastating diseases like Alzheimer’s, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA. Patient safety and drug efficacy must remain at the core of our nation’s pharmaceutical regulatory review process.”

The Chair of the Committee on Oversight and Reform, Carolyn Maloney, also spanked the FDA:

“I am hopeful these findings are a wake-up call for FDA to reform its practices and a call to action to my congressional colleagues to continue oversight of the pharmaceutical industry to ensure they don’t put profit over patients.”

I have Lost Faith in the FDA Because of Two Drug Approvals!

Aduhelm:

What adds insult to injury is how the FDA ignored its own panel of outside experts during the review process. These FDA advisory committee members were distinguished researchers and clinicians in the field of neuroscience. They did not believe that Aduhelm was worthy of FDA approval.

The agency usually follows the advice of such authorities. In the case of Aduhelm, however, the FDA ignored its own advisory committee and even went so far as to grant the drug “accelerated” approval status.

An internal review by the FDA itself was less critical than the Congressional committees, but even it concedes that the Aduhelm process “exceeded the norm in some respects.”

Leqembi:

The FDA approved a similar drug, called lecanemab (Leqembi). Again, the FDA bypassed an outside panel of experts and granted the drug “accelerated” approval.

Read more about this approval at this link. The drug can cause brain swelling and brain bleeding as well as infusion-related reactions such as flu-like symptoms, nausea, vomiting and changes in blood pressure.

The FDA reports other side effects:

“…headache, confusion, dizziness, vision changes, nausea and seizure.”

There have been three deaths associated with lecanemab.

Were the Drugs “Effective”?

The most disturbing aspect to the entire Aduhelm and Leqembi approval process is that we do not have good evidence these drugs can improve memory, help ward off confusion, enable patients to continue working and driving or keep them out of nursing homes.

Those are the kinds of things that people actually care about when assessing the effectiveness of drugs for Alzheimer’s disease. Such criteria should be essential when evaluating medications of this sort. Remember the dictionary definition of effectiveness:

“producing a decided, decisive, or desired effect.”

Have Doctors Lost Faith in the FDA?

Spherix Global Insights is a “market intelligence firm” that focuses on medical specialists. In the summer of 2021 it reported on a survey that revealed eroding confidence in the FDA.

It found:

“A survey of 252 specialists in dermatology, gastroenterology, nephrology, neurology, and rheumatology, fielded on July 25, revealed confidence in the FDA is swiftly dwindling. Only 36% express a high level of assurance in the agency, with nearly one-half reporting that their confidence with the FDA has eroded in the past year. Sentiment is most negative as it relates to being unbiased/apolitical, the speed of New Drug Application (NDA) reviews, and transparency with the medical community.”

Has the Public Lost Faith in the FDA?

A survey by the Robert Wood Johnson Foundation and reported by the Harvard T.H. Chan School of Public Health offers this overview:

“…51% rate it [the FDA] as doing a fair or poor job.”

When asked how much they trust the recommendations of the FDA, only 37% reported a “Great deal/Quite a lot.”

Please note that the 37% great deal of trust by the public corresponds to the 36% of the specialists. Bottom line seems to be that most people have lost trust in the Food and Drug Administration.

Have You Lost Faith in the FDA?

I would like to get your perspective. How much faith do you have in the FDA’s drug approval process? Do you trust the FDA’s ability to inspect foreign drug companies? Does the FDA provide transparency when it comes to generic drug quality? Does the assurance that all FDA-approved drugs are safe and effective give you confidence? Please share your thoughts in the comment section below. Do you know someone who might benefit from reading this article? If so, please scroll to the top of the page and email it to a friend or family member.

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