We are always surprised that medications seem to be held to a much lower standard than any other product or service. Why do healthcare professionals and patients willingly accept such poor performance from pharmaceuticals? They would not tolerate it from a mobile phone, an automobile or a bank. Even more puzzling, most people have no clue if a drug’s benefits outweigh its dangers.
To be fair, such data may be hard to come by. However, even when the information is available, most healthcare providers do not bother to inform their patients what the actual benefits are in ways they can truly understand.
That is also true when it comes to risks. It is not acceptable to tell a patient that a medication can cause muscle pain or kidney stones unless there is a frame of reference. That is why it is so important for people to read and understand meaningful details about a drug’s benefits and its risks.
Reading Instructions Matters!
Every time we take a shower, we are reminded what happens when you ignore instructions. Several years ago, we purchased a new shower door and hired a handyman to install it.
This was not his area of expertise, but he didn’t bother to read the instructions carefully. He hung the door backwards. As a result, every time we slide the door open it squeaks like crazy and does not create a perfect seal.
Do-it-yourself projects often end badly when we don’t read the instructions first. So why do we assume we can take medications without reviewing information about them? Even when we read drug information, it can be woefully inadequate.
Prescribing Information about a Drug’s Benefits and Risks Is Dreadful!
When you pick up your prescription from the pharmacy, what do you do with the little leaflet included in the bag? Many people throw it out without a glance. Some may stuff it in a drawer for future reference. We suspect that only a few ever read it.
Those who do read the insert may find it overwhelming and give up after a few sentences. Others may assume the warnings have nothing to do with them.
My Story with Methimazole:
Let me provide a personal example. I have a mildly overactive thyroid gland. To keep it under control I take a medication called methimazole (Tapazole). It was first approved by the FDA in 1950, so this medication has been around for a very long time.
The pharmacy provides me with a medication guide that lists 25 potential side effects in one giant paragraph. After a sentence or two I tune out, just like almost everyone else. There is no quantitative data to provide a sense of what is common and what is really rare.
The one “precaution” that I find particularly bizarre is this one:
“Before taking methimazole, tell your doctor or pharmacist if you are allergic to it”
Warnings about drug allergies are common, but do they make any sense? How would people know if they are allergic to a medication until they actually take it?
The Rinvoq Example:
If you watch television at all, chances are good that you have seen a Rinvoq commercial. This medication is prescribed for a number of conditions, including rheumatoid arthritis. People are shown being very active: tap dancing, hiking, exercising, riding a motorcycle, hauling heavy trees and riding a zip line.
While distracting images flash before your eyes, an announcer speeds through the following adverse reactions:
“Rinvoq can lower your ability to fight infections, including TB. Serious infections and blood clots, some fatal, cancers, including lymphoma and skin cancer, death, heart attacks, stroke and tears in the stomach or intestines occurred. People 50 and older with at least one heart disease risk factor have higher risks. Don’t take if allergic to Rinvoq as serious reactions can occur.”
Deciding If a Drug’s Benefits Outweigh Its Dangers:
Unanswered Rinvoq Questions:
- How would you know you are allergic to Rinvoq if you have never taken it?
- What is the likelihood someone will get cancer after taking Rinvoq?
- How many people get infections while taking Rinvoq? Is it 1 in 10, 1 in 100 or 1 in 10,000?
- If someone is over 50 and has high cholesterol, how likely is it that Rinvoq could cause a heart attack or stroke? Numbers please!
A Reader Asks About a Drug’s Benefits vs. Risks:
One reader of this column wrote:
“Why does the FDA approve drugs that have very serious side effects that could make your condition much worse? When I see drug commercials on TV with a long list of scary side effects, I wouldn’t want to take something like that. Perhaps the complications only happen occasionally, but I believe that many doctors and pharmacists may not take these side effects seriously.”
This comment reveals the problem with most drug information. TV commercials that list adverse reactions like serious infections, fatal blood clots, cancers, heart attacks, strokes or death do not tell you how frequently these problems may occur.
If the risk of experiencing a heart attack is 1 in 500,000 after five years, many people might say that is a lottery I am willing to play. If the risk is 1 in 100, some people might decline to take the gamble.
We are rarely told how often “common side effects” like muscle pain, weakness, cough or stomachache are likely to occur with our medicine. That’s true in television commercials as well as patient leaflets. Even the FDA’s official prescribing information rarely provides accurate data on benefits as well as risks.
The Statin Challenge:
Do the Drug’s Benefits Outweigh the Dangers?
At least 50 million Americans swallow a statin-type cholesterol-lowering drug daily. Atorvastatin is the most frequently prescribed drug in America.
I have been analyzing the benefits and risks of medications for more than 50 years. No other category of medications has so dominated American medicine as statins.
The guidelines that influence prescribing behavior insist that virtually all older people must take a statin. This often includes people who do not have diagnosed heart disease. They may not even have high cholesterol levels.
This is called primary prevention. Any doctor who does not prescribe a statin to a man over 60 or a woman over 65 could be criticized by medical authorities. We explain the guidelines at this link:
“Should Everyone Over 65 Take a Statin to Prevent a Heart Attack?”
There’s no question that statins lower LDL. The question is whether that will result in a longer, healthier life for people without diagnosed heart disease.
The Numbers Behind a Drug’s Benefits (NNT):
The FDA maintains that it only approves medications that have been proven safe and effective. What it does not do, though, is explain what that really means.
We have often tried to explain drug benefits by citing the NNT (number needed to treat). In other words, how many people have to take a particular medicine for one person to experience a measurable benefit?
Dr. John Abramson calculated the NNT for statins at this link. It provides some context for statin benefits.
“Why Didn’t Statins Protect Dad from Clogged Coronary Arteries?”
The executive summary is that a lot of people (Dr. Abramson says 140) have to take a statin for five years for one person to avoid a nonfatal heart attack.
Sadly, we have come to the conclusion that NNT is far too challenging to be useful for most patients and prescribers.
How Much Longer Will You Live If You Take a Statin?
There is another way to explain benefit without getting too statistical. It has to do with lifespan. Most people seem to grasp this concept without too much trouble. Here’s the bottom line question. How much longer will drug X extend your life?
A bunch of Danish researchers describe the problem this way:
“One challenge in the practice of medicine lies in adequately explaining the effects of a proposed intervention to enable a patient to make an informed decision. With regard to preventive interventions, such as statin use, effect size is traditionally expressed as relative/absolute risk reductions or ‘number needed to treat’ (NNT). However, such measures are not necessarily best for conveying intervention effect.
“When contemplating preventative treatment, the additional time free of an undesirable clinical event can be considered more relevant. This average postponement of the study outcome represents an alternative to traditional effect measures for preventive treatment.”
Their comprehensive review of 16 clinical trials found that people taking statins get on average 12 extra days of life thanks to the medicine (Journal of General Internal Medicine, Aug. 2019). The analysis showed that people with heart disease get an average postponement of death by 17 days, while those without heart disease get 10 additional days.
Cardiologists will undoubtedly want to know how long the trials lasted. Some were as short as 3 years. Others lasted about 6 years.
Here is what the investigators report when it comes to length of clinical trial:
“We examined the effect of trial duration on postponement and found a much larger postponement among the trials with a trial duration of 5 years and above, compared to below 5 years (19 days vs. 6 days).”
Another study published in the journal Basic Clinical Pharmacology & Toxicology (Feb. 2021) analyzed 19 randomized, placebo-controlled trials of statins.
The envelope please:
“For four major outcomes, that is, cardiovascular mortality, non-cardiovascular mortality, any myocardial infarction [heart attack] and any stroke, the summary outcome postponement was 9.3, 1.5, 18.0 and 6.1 days, respectively, when standardized to 5 years of trial duration.”
In this analysis, people could expect to postpone death from cardiovascular causes by less than two weeks.
To be fair, other investigators have estimated statin use extends survival times by longer than a couple of weeks. But it should be clear that statins are not magic shields against fatal heart attacks.
What About Side Effects When Assessing a Drug’s Benefits?
Statins have side effects as well as desirable outcomes. People taking statins may experience muscle pain or other problems.
A renowned cardiologist, Dr. Steve Nissen of the Cleveland Clinic, wrote in the New England Journal of Medicine (March 4, 2023):
“…7 to 29% of patients report adverse musculoskeletal effects that prevent them from using statins…”
Dr. Nissen is a statin enthusiast, but he acknowledges that some people do indeed experience muscle pain and weakness. That can interfere with exercise. Most cardiologists, including Dr. Nissen, admit that exercise is essential for heart health. If people stop moving because of muscle pain, they increase their risk for all sorts of health problems.
Final Words:
People deserve clear information that will help them decide if the advantages of a new medicine are greater than the possible harms. Patient medication information needs to be clear and concise so that people can use it to make decisions. That is currently not readily available.
Here are some suggestions to help you in your decision process:
Ask your doctor:
- How long will this medicine postpone a bad outcome (such as heart attack, stroke, kidney damage or death)? Is it days, weeks, months or years?
- What is the number needed to treat (NNT)? How many people have to take this medicine for one to avoid a bad outcome?
- What are the most common side effects? How common is common? Please provide percentages such as 30% of patients experience this complication.
- What adverse reactions are so serious that I need to go straight to an emergency department? Which are worrisome and require a call to your office?
Learn About a Drug’s Benefits and Risks Yourself:
Try DailyMed:
You can look up almost any medication in the National Library of Medicine DAILYMED website. Just put the generic or brand name of your medicine in the search box at the top of the page.
When you click on your medicine you will see a variety of options including INDICATIONS AND USAGE, DOSAGE FORMS and STRENGTHS, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, DRUG INTERACTIONS and CLINICAL STUDIES, to name just a few of the categories.
I find the ADVERSE REACTIONS category and the CLINICAL STUDIES section especially helpful. In many cases you will see a box with actual side effects stats. For example, the official prescribing information for the hot weight loss drug Wegovy (semaglutide) lists nausea at 44%, diarrhea at 33%, vomiting at 24%, constipation at 24% and headache at 14%. That gives you some idea how likely you are to experience such adverse reactions.
When it comes to CLINICAL STUDIES, you can see how well a drug works. It is trickier to tease out benefit, but there are often data you can review. For example, gabapentin is frequently prescribed for nerve pain.
The gabapentin official prescribing information provides a graph over 8 weeks. The pain scale ranges from 0 to 10. Those on placebo had a pain score of a bit higher than 6 after 8 weeks. Those on gabapentin had a pain score of just above 4. That gives you some idea of how effective gabapentin might be against postherpetic neuralgia.
Check PubMed:
Finally, you can visit the National Library of Medicine collection of medical journals at its PubMed website. You can put the generic name of your medicine into the search engine. You might want to add medical terminology such as efficacy or adverse reactions. You will likely be overwhelmed with references, but sometimes you can strike gold and really learn about the ins and outs of your medicine.
Ask The People’s Pharmacy:
You can always ask us a question. We do get a lot of questions, so please be patient. We can’t respond to every inquiry, but we do try to put questions of broad general interest in our syndicated newspaper column.
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