The People's Perspective on Medicine

FDA Boss Infuriates Patients with Drug Safety Tweet

Is your medicine safe and effective? The FDA says if it approves a drug it is, by definition, safe. But drug safety and effectiveness are NOT that simple!

Dr. Scott Gottlieb is the Commissioner of the Food and Drug Administration. That means he is the top cop when it comes to all our medications. Dr. Gottlieb stirred up a lot of excitement on Valentine’s Day. He sent out what he probably thought was a cute little Tweet:

“Some pills are red,
“Some pills are blue,
“All are safe and effective,
“If they undergo FDA review.”

The implication of this message seems to be that if the FDA reviews and approves a medication, you can rest easy. The FDA Commissioner assures you that it is “safe and effective.”

Drug Safety Tweet Aggravates Patients:

Hundreds of people responded to this message. One noted that defining “safe and effective” can be complicated. We couldn’t agree more.

The Merriam-Webster dictionary defines safe as:

“1: free from harm or risk

“2a: secure from threat of danger, harm, or loss

“3: affording safety or security from danger, risk, or difficulty

“5a: not threatening danger: HARMLESS”

FDA Approval Does NOT = Safety!

The FDA routinely approves drugs that can cause death as a possible side effect. All you have to do is close your eyes and listen to the commercials on television to confirm that FDA-approved drugs can lead to life-threatening consequences such as kidney failure, cancer, coma or stroke.

The Humira (Adalimumab) Example:

You have no doubt seen a Humira commercial on TV. It is advertised to treat ulcerative colitis (UC), Crohn’s disease, psoriasis, psoriatic arthritis and rheumatoid arthritis.

According to The Motley Fool (Dec. 18, 2017):

“Humira has been the best-selling drug in the world for years. AbbVie is on course to make well over $18 billion from the autoimmune-disease drug this year.”

If you watch one of the Humira commercials, you will hear the announcer say:

“Humira can lower your ability to fight infections including tuberculosis. Serious, sometimes fatal infections and cancers, including lymphoma, have happened, as have blood, liver and nervous system problems, serious allergic reactions and new or worsening heart failure…”

You can watch one of the many Humira commercials at this link.

By the way, heart failure can also be fatal.

Does Humira fit the definition of safe? If you apply the Merriam-Webster phrase, “free from harm or risk,” we do not see how the FDA can say the drug is safe unless, of course, the agency has a very different definition of drug safety that only applies to medications and includes death as a possibility.

FDA-Approved Drugs That Have Been Recalled:

Baycol (cerivastatin):

Another Tweet in response to the Commissioner’s Valentine poem offers a list of drugs that were approved by the FDA and later recalled. They include cerivastatin (Baycol), a cholesterol-lowering statin that caused severe muscle breakdown, kidney failure and deaths. It took three years for the FDA to recognize the danger and get the drug off the market.

Bextra (valdecoxib) and Vioxx (rofecoxib):

Valdecoxib (Bextra) and rofecoxib (Vioxx) were anti-inflammatory pain relievers. They were on the market for years before the FDA realized that these drugs were associated with heart attacks and strokes.

DES (diethylstilbestrol):

Diethylstilbestrol (DES) was approved by the FDA in 1940 to prevent miscarriages and premature labor. Not only was it ineffective, DES caused countless cases of reproductive cancers in young women exposed in utero. Even though the drug was taken off the market in 1971, grandchildren of the women who took it may still be at risk for reproductive tract anomalies.

Meridia (sibutramine):

Sibutramine (Meridia) was approved for weight loss in 1997. Although warning signals cropped up early in the 21st century, FDA had it removed in 2010 for increasing the risk of heart attacks and strokes.

There is no need to continue this list. Suffice it to say, FDA review does not guarantee drug safety. Even effectiveness is not as obvious as Dr. Gottlieb implied.

Does FDA Approval = Effectiveness?

The English Oxford Living Dictionaries define “effective” as:

“1: Successful in producing a desired or intended result.”

Merriam-Webster defines effective as:

“1a: producing a decided, decisive, or desired effect”

We suspect that many people believe that FDA approval means that most people will experience a “decisive or desired” result from a prescribed medicine. That is not what the FDA means, though.

Antidepressant Effectiveness?

Take antidepressants, for example. There are millions of prescriptions written each year for drugs like fluoxetine, paroxetine and sertraline. There is no doubt that some people with severe depression benefit from such medications.

Most of these antidepressants, however, are taken by people with mild to moderate depression. One meta-analysis concluded that depressed patients with mild or moderate symptoms got little or no benefit beyond placebo. (JAMA, Jan. 6, 2010). 

The Lipitor (Atorvastatin) Asterisk:

Many drugs deemed effective by the FDA are just a little better than placebo. This is not always clear in marketing materials unless you read the fine print.

Lipitor was advertised as reducing the risk of heart attack by 36 percent in high-risk patients.

This was decorated with an asterisk signaling the fine print:

“That means in a large clinical study, 3 percent of patients taking a sugar pill or placebo had a heart attack compared to 2 percent of patients taking Lipitor.”

In other words, one person out of 100 taking Lipitor avoided a heart attack compared to placebo. One could also flip the coin and say that 99 people out of 100 did not benefit from Lipitor.

No wonder so many people objected to Dr. Gottlieb’s over-simplistic Tweet that all FDA approved drugs are “safe and effective.”

What’s Your Definition of Drug Safety?

Do you think the FDA Commissioner’s Valentine Tweet was sweet? Do you think most health professionals understand the FDA’s “definitions” of drug safety and effectiveness? Please add your thoughts in the comment section below. Here again is Dr. Gottlieb’s Tweet for your consideration:

“Some pills are red,
“Some pills are blue,
“All are safe and effective,
“If they undergo FDA review.”

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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Scott Gottlieb resigned finally. He was an astonishingly bad choice to head the F.D.A. He was an investor in pharmaceutical companies. He even had the gall to argue that the industry is overburdened by regulations. He said an excess of safety concerns would inhibit development and review of generic drugs. Reading his bio on Wikipedia gave me a chill. So it wasn’t surprising that he would send out a nauseatingly cute valentine with a message like that.

Many, many years ago I remember 60 Minutes exposing the fact that many of the FDA trials were being financed by Big Pharma. I have not trusted them since.

I was ordered a beta blocker about a year ago. One pill later I had NO energy. I thought, no way will I continue with this drug. And it may apply to the whole class of beta blockers rather than one brand.

Safe & effective? Probably rarely if ever.

Joe and Terry Graedon
Please train up someone to take your place (when you do retire) you
provide a priceless service..

All anyone has to do is look up a drug in the FDA Adverse Event Reporting System (FAERS) to see what side effects have been reported. Some very common drugs list life-threatening side effects. However, most doctors do not report them, preferring to vaguely place the blame on something else and leaving that responsibility to affected patients. The FDA seems to turn a blind eye on the reports it has collected, putting countless people in danger. Now that Scott Gottlieb has announced his resignation, maybe he discovered that the job was much too big and serious for a misplaced nursery rhyme.

I agree with Darlene from Texas: The FDA is useless.
If we can’t trust the FDA, why do taxpayers have to support it?

I’m a Master’s prepared registered nurse with decades of experience, including exposing deficiencies in a variety of health care systems, working for state and federal government agencies. When Dr. Gottlieb assures the public via kindergarten-level cutsie poems, I need an anti-emetic! The FDA has proven itself to be an over-sized yet ineffective, costly federal agency which rarely meets even its low level goals. Yet some continue to believe they “ensure” our safety when taking drugs.

I believe approximately 50% of our drugs, or their constituents, come from outside the US. Those foreign drug factories have minimal or no oversight by the FDA. Safe drugs? Who knows. How many of those companies have been shut down for quality issues (sometimes repeatedly), or their leaders convicted of crimes?

Within and outside the US the FDA prioritizes its activities to the point of near-complete ineffectiveness and often focuses on the low-hanging fruit, ignoring more meaningful issues. Even those requirements and quotas for oversight often are not achieved. Rules have loopholes a semi-truck could drive through (i.e. generic versions of the same drug vary widely and result in effects that vary widely). The length of time the FDA delays in approving new drugs is unwarranted, yet they still do not manage to detect significant problems. Later, a given drug receives new warnings, even “black box” notices, though these are often ignored. High level officials pass back and forth working between the government and the drug companies. It’s hard to determine what their motivation might be on any given day.

The FDA should be our first line of defense against RISK and INEFFECTIVENESS. Because the subsequent layers of drug administration comprise increasingly serious levels of risk: manufacturing, packaging, transporting (under required environmental circumstances), sorting, storing properly, distribution, prescribing, information dissemination, dispensing, administration, patient teaching, risk/benefit discussion with patient consent following such a discussion, accurate record-keeping, an endless list of points where errors can and DO occur. More errors occur involving drugs than in any other type of intervention, including surgery.

D. Gottlieb needs to stop patting our heads and do his job, which is to enjoin the FDA to do theirs.

Follow the money. It’s all about the money.
Any medicines we take may seem to help one thing, but they always seem to take away something else – just as important – as a trade-off. I’m beginning to suspect that none of us are going to make it out of this thing alive. |:-)

I would like to warn folks about Dexilant, the acid-reducing drug. On November 6,2018 my white cell count was 5.4. I started taking Dexilant on December 9, 2018. On January 31, 2019 a blood test showed my white blood cell count to be 2.0. In the general side effects for Dexilant it does not show anything regarding white blood cells. However, if you go to rare side effects for Dexilant it shows that the drug decreases the white blood cells as well as red blood cells.

THIS DRUG SHOULD BE TAKEN OFF THE MARKET.

The pharmaceutical industry is in the business of making money. The fewer prescriptions you can take the better.

Big Pharma dropped in with bags of cash,
Forcing the FDA to hide their stash,
No patients now are being misled,
Because it all goes out “Approved By The Feds”

I believe they mean “safely and effectively” makes vast amounts of money for big pharmacy. It’s been VERY obvious for a long time that patient safety is an extremely low priority if it exists at all, and the laser focus is huge money.

I think the FDA is useless! They approve these drugs then you find out a few years later they should NOT have been approved! Why is it frequently European countries discover the problem before the US FDA?

One big issue: even if the drug is safe, the way it is prescribed may be Unsafe. Amiodarone almost killed me because of the dose prescribed. Thank goodness the cardiac rehab nurse understood the problem!

One of the most negative impacts on my quality of life is the proliferation of TV commercials for drugs and medical procedures and the recasting of my physician’s role to prescriber. Recently we have been barraged with reassurances about the safety of vaccines. I myself avoid them, as the FDA as other agencies have lost my trust, and I feel I must do my own research and make my own best guess about what is safe and in my best interests. Years ago my physician was a trusted partner in healthcare decisions but these issues now of safety, trust, transparency go all the way back to physician training. A challenging world that we live in.

I think the FDA should do their job and stop recommending blood pressure medicine that causes cancer. Then denying people pain medication for medically-proven pain patients.

GREAT ARTICLE !!

As a pharmacist, I’m sick of manipulative drug advertisements. Whereas the vast majority of people use the word “drugs,” Big Pharma refers to them as “medicines.” I assume this is done to conjure up images of life-saving agents like insulin and penicillin. Whereas most people use terms like “side effects” or “adverse effects,” Big Pharma uses terms like “untoward effects” to soften the impact. The latest thing is for the announcer in drug commercials to list various scary adverse effects and say that those effects “have happened.” Apparently Big Pharma has calculated that the phrase “have happened” is less scary than “have occurred.”

When Joe and Terry Graedon retire, I honestly don’t know where I’ll go for unbiased drug info.

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