The U.S. Food and Drug Administration (FDA) has repeatedly advised the majority of the population to get vaccinated and boosted against COVID-19. Florida’s surgeon general, on the other hand, rejected that advice in September 2023, and told Floridians that healthy people under the age of 65 didn’t need the vaccine. More experts came out dismissing the Florida surgeon general’s advice, siding with the FDA.
Still, the disconnect between the experts caused confusion. The debate about whether or not we should get COVID-19 booster shots may have been more public and passionate than most medical debates, but it is not entirely unusual in the medical world for there to be disagreement about the best course of treatment. This is where the idea of getting a “second opinion” comes from. When you get conflicting messages about how to manage a particular condition, how can you decide what to do?
We talked to MedShadow Medical Advisory Board members Terry and Joe Graedon, producers and co-hosts of the People’s Pharmacy about how the medical community develops a consensus, and how you can make medical decisions for yourself.
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How Does the Medical Community Make Guidelines?
“How we achieve a kind of group think about a particular drug or treatment is a very complex process—whether it’s the COVID vaccine, statins for cholesterol, or how you treat severe chronic pain—and it’s actually more controversial than you would think,” says Joe.
While experts may occasionally get their data from a few different sources, more often than not, Terry says they usually are starting with the same studies.
“It’s a question of how they interpret the data they’ve gotten. The data is rarely as precise as we’d like it to be to balance the benefits and risks [of different treatments].”
She adds that, while we may start with data from clinical trials run by the drug manufacturer, once a drug is out on the market, we do get new data over time that can—and should—sometimes cause clinicians to change their minds.
For example, the inability to achieve an orgasm while taking the common antidepressants, selective serotonin reuptake inhibitors (SSRIs) wasn’t considered frequent or concerning when the drugs first came out.
“People didn’t want to talk about sex with the doctors, and doctors weren’t asking about it,” Terry says. “But as time went on, people started taking these antidepressants and they started saying ‘Doc, I just can’t do it anymore. It’s frustrating, and my partner is upset about it, and it’s just really having a big effect on my life. Even if the depression is better, the sex life is terrible.’”
Now, experts estimate that 42% of women who take antidepressants report problems with orgasms, and many other people struggle with desire and erectile dysfunction. These are things. you might want to know when making medical decisions.
What to Ask Your Healthcare Provider
In a perfect world, we’d all be experts in reading medical research and have unlimited time to do so. Unfortunately, that’s not the reality, which is why Terry and Joe recommend working with your healthcare provider.
But, don’t just take any medication he or she prescribes for you. Ask these important questions first. In some cases, your provider may have to do some research and get back to you. The questions “force your clinician to dig for some quantitative data,” says Joe.
How to Ask About the Treatment’s Benefits
The most critical question to ask about the benefits of the drug is “what is the absolute risk reduction?” they explain. “In other words,” Terry says, “how likely is it that somebody with my condition is going to get a benefit from this medication?” This is a very different number from the relative risk reduction that drug companies like to advertise.
What is Absolute Risk Reduction?
“You’re told you need to take this drug because it’s going to prevent some kind of a problem,” says Joe. For example, statins are used to lower your cholesterol because high cholesterol raises your risk of having a heart attack. High cholesterol itself won’t cause you many symptoms, so the main benefit of taking the drugs is to reduce your risk of heart attack.
Let’s say a clinical trial of the drug lasted five years, and included 200 people with high cholesterol. One hundred people got the statin and one hundred got a placebo. Over the next five years, five people had heart attacks: two in the statin group and three in the placebo group.
“The drug company will say, ‘well that’s a 33% reduction,’” explains Joe. That number is the relative risk reduction.
But the absolute risk reduction is only 1%. The drug prevented a heart attack in one percent of people (in this example, one person) who likely would have had one without it. This number tells you a lot more about how likely the drug is to actually benefit you. Ask your doctor what the risk is for someone like you if you don’t take the drug versus if you do.
“People who are extremely risk averse might say, ‘OK, a 1% reduction is worth it,’” says Terry, while others might prefer to avoid potential side effects and accept a 1% higher risk of a heart attack. That it is up to you.
What you don’t want is for your doctor to tell you that this is an effective drug to lower cholesterol or lower blood sugar (for diabetes), explains Joe. Those are surrogate endpoints—measures used in trials that suggest the drug will benefit you but don’t actually prove that it will prevent a future bad outcome.
Essentially, if bad outcomes are associated with high cholesterol, scientists say it’s reasonable to believe that having lower cholesterol will lower your risk of those bad outcomes. It would take a lot longer for a clinical trial to follow people on a cholesterol-lowering drug for a decade to determine if they actually had a lower risk of heart attacks, so instead a trial will measure their cholesterol levels. If the drug reduces the cholesterol levels, the FDA will say it’s reasonable to assume it also lowers your risk of heart attack. The cholesterol levels are a surrogate endpoint.
As drugs hit the market, and more and more people take them, we find out more about your actual risk over time. You need to know whether the drug will actually lower your risk of heart attack or diabetes complications such as kidney damage or visual problems.
Questions About Side Effects
The two most important questions about side effects are what’s common and what’s dangerous?
Naturally, you want to know which side effects you’re most likely to experience. These might include things like nausea,upset stomach or fatigue. But then, you’ll also want to review the worst-case scenarios, too. These side effects may be exceedingly rare, but just in case, you need to know what they are, and how to recognize if they’re happening, so you can get help right away.
Sticking with the heart disease prevention example, Terry and Joe explained that there is a rare, but very dangerous, side effect of the blood pressure drug lisinopril. It can show up when you first start taking the drug, or even years later.
“The reaction is a sense of numbness and swelling in the lips, in the mouth, in the tongue, in the pharynx, in the throat. And those tissues can swell up so much that you can’t breathe.”
The first sign is just a little tingling feeling on your lips, mouth or throat, explains Terry. If you’re using this drug and you start to feel that sensation, you need to know to get emergency attention.
How to Review the Research Yourself
Making medical decisions yourself can be difficult. It’s not easy to review medical literature on your own. That’s one of the reasons MedShadow exists—to help you make sense of the research that’s out there. However, if you’d like to head to your healthcare provider’s office as prepared as possible, here’s what Terry and Joe suggest.
First, look at the official prescribing information. You can find this on the FDA label, or on the NIH website, DailyMed. Here, you’ll find an overview of what researchers found in the company-sponsored clinical trials. You’ll find lists of common dosages and adverse effects that showed up in the trials.
Then, if you’re interested in any particular side effect, Terry says that the next step is to do a search on PubMed. For example, you can search the name of the drug and “diarrhea” to see if there’s additional literature.
“That can help you sort out what’s fluff and what might actually be of concern,” she says. This is something the Graedons spend a lot of their time doing, however, and not all research is equal, so it’s crucial that you still discuss your findings with a professional.
