Drugs’ Side Effects Can Be Different If You Carry Extra Weight

Does a person’s higher weight impact how effective a recommended drug dosage may be?

Researchers found, for example, that common versions of Plan B (levonorgestrel), the morning after emergency contraceptive pill, was less effective in women who weighed more than 165 pounds, and not effective at all for those over 175. Last year, that fact caught a wave on social media after TikToker @anadelrey.xo shared a video suggesting that anyone over 150 to 155 pounds should take two pills instead of one. Note: Specialists do not recommend taking two pills. Instead, they suggest the alternative medicine Ella (ulipristal). 

@anadelrey.xo Reply to @yanieboyd what if I don’t wanna be 155 😭 plan b is meaty-phobic 🤚🏽 #planb #TakeTheDayOffChallenge #BenefitOfBrows ♬ eredeti hang – Petra Horváth

There’s conflicting evidence about whether the assertion is true. In 2013 and with support from regulators, European manufacturers changed the label to reflect the risk of inefficacy in patients with higher weights. Three years later, the Food and Drug Administration (FDA) announced that the evidence of the drug being less effective in women with obesity was inconclusive. Carrying extra fat tissue can change how your body reacts to some drugs, and a lot more research needs to be done to determine which treatments are affected and how doses should be adjusted.

How Excess Fat Impacts a Drug’s Side Effects

Carrying extra weight impacts the way your body responds to different drugs in a variety of ways. For some drugs, it may increase their efficacy and side effects; for others, it may lessen them. If you’ve been prescribed more than one drug, excess fat can also impact how they interact with each other. Talk to your healthcare provider about how your dose may need to be adjusted based on your body’s composition, especially if you’re experiencing side effects. 

Some of the most common ways fat can influence drugs in your body are by: 

1. Slowing Drug Uptake

“Medication needs to cross blood-brain barriers, fat barriers and other barriers to reach the correct destination,” explains Hector Perez, MD, a surgeon at Renew Bariatrics in Tijuana and Cancun, Mexico. If there’s extra fat tissue, this journey can take longer. You may need a higher drug dose to realize the same effect as someone who doesn’t have excess fat.

2. Increasing Drug Storage

Some drugs and supplements are stored in water, others are stored in fat. If you have extra fat tissue, the types of drugs stored in fat will stay in your body longer. That means that as you take more doses, the amount of drugs in your body can build up to higher levels than you intended, because there’s extra leftover from previous doses. That can cause more intense side effects.

3. Retarding Drug Clearance Through Liver

“Medications should be adjusted in liver and kidney disease. The medication class that comes to mind are the antipsychotics for schizophrenia and other unspecific psychosis and anti-seizure medications,” says Joseph Claiborne III, MD, a physician with the Methodist Family Health Center in Preston Hollow, Texas. Most medicines are metabolized through your liver. Carrying extra fat can cause a buildup of fat on the liver that can reduce its efficiency with which your body breaks them down.

Some drugs and supplements that might be metabolized differently based on your body weight include:

• Opioids
• Anesthesia
• Antifungals
• Antibiotics and other antimicrobials
• Vitamin D
• Fertility drugs

Before starting a new drug, it’s important to ask your doctor how your body’s composition might affect how well that drug works and how it might raise or even reduce your likelihood of experiencing side effects. For many conditions, regular exercise and a healthy diet can help reduce your symptoms. However, if you do lose or gain weight during the course of treatment, be sure to check in with your provider to evaluate whether a new dose or even deprescribing—reducing the number of drugs you take—might be called for.

How Fat Is Also a Gender Issue

Women noted adverse effects from medicines nearly twice as often as men do, according to a 2020 study, published in the Biology of Sex Differences. In 2021, MedShadow reported that there are numerous differences in the way men and women metabolize drugs, but one important one has to do with their differing body compositions. Women naturally carry more fat tissue than men and that can make it harder for a drug to reach its intended target, or it could keep that drug in your body longer. Fat plays an important role in how our bodies process and store the drugs we’re prescribed and can be an important variable to consider when our healthcare providers are determining the optimal doses for treatment. 

How Doctors Can Be Dismissive of Overweight and Obese Patients

Having obesity has for years made it harder for some patients to receive high-quality care from their physicians.Research has shown that doctors communicate differently with overweight patients, spending less time expressing empathy and concern, for example. In March 2020, doctors published a statement in Nature, calling for an end to weight stigma.  At times, doctors tell the patient the problem will go away if they lose weight, only to find out later that the patient has had a serious illness that could not be cured by weight loss. For example, in 2016, STAT reported a story about a woman who saw 11 different doctors who all told her to lose weight. She was later diagnosed with lung cancer that was so severe she had to have an entire lung removed.

If your physician dismisses your concerns, it’s time to find a new provider.  

 

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Why Pregnant People Were Left Behind While Vaccines Moved at ‘Warp Speed’ to Help the Masses

Kia Slade was seven months pregnant, unvaccinated, and fighting for breath, her oxygen levels plummeting, when her son came into the world last May.

A severe case of covid pneumonia had left Slade delirious. When the intensive care team tried to place an oxygen mask on her face, she snatched it away, she recalled. Her baby’s heart rate began to drop.

Slade’s doctor performed an emergency cesarean section at her bedside in the intensive care unit, delivering baby Tristan 10 weeks early. He weighed just 2 pounds, 14 ounces, about half the size of small full-term baby.

But Slade wouldn’t meet him until July. She was on a ventilator in a medically induced coma for eight weeks, and she developed a serious infection and blood clot while unconscious. It was only after a perilous 2½ months in the hospital, during which her heart stopped twice, that Slade was vaccinated against covid-19.

“I wish I had gotten the vaccine earlier,” said Slade, 42, who remains too sick to return to work as a special education teacher in Baltimore. Doctors “kept pushing me to get vaccinated, but there just wasn’t enough information out there for me to do it.”

A year ago, there was little to no vaccine safety data for pregnant people like Slade, because they had been excluded from clinical trials run by Pfizer, Moderna, and other vaccine makers.

Lacking data, health experts were unsure and divided about how to advise expectant parents. Although U.S. health officials permitted pregnant people to be vaccinated, the World Health Organization in January 2021 actually discouraged them from doing so; it later reversed that recommendation.

The uncertainty led many women to delay vaccination, and only about two-thirds of the pregnant people who have been tracked by the Centers for Disease Control and Prevention were fully vaccinated as of Feb. 5, leaving many expectant moms at a high risk of infection and life-threatening complications.

More than 29,000 pregnant people have been hospitalized with covid and 274 have died, according to the CDC.

“There were surely women who were hospitalized because there wasn’t information available to them,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Vaccine developers say that pregnant people — who have special health needs and risks — were excluded from clinical trials to protect them from potential side effects of novel technologies, including the Pfizer and Moderna mRNA vaccines and formulations made with cold viruses, such as the Johnson & Johnson vaccine.

But a KHN analysis also shows that pregnant people were left behind because including them in vaccine studies would have complicated and potentially delayed the delivery of covid vaccines to the broader population.

A growing number of women’s health researchers and advocates say that excluding pregnant people — and the months-long delay in recommending that they be immunized — helped fuel widespread vaccine hesitancy in this vulnerable group.

“Women and their unborn fetuses are dying of covid infection,” said Dr. Jane Van Dis, an OB-GYN at the University of Rochester Medical Center who has treated many patients like Slade. “Our failure as a society to vaccinate women in pregnancy will be remembered by the children and families who lost their mothers to this disease.”

New Technology, Uncertain Risks

At the time covid vaccines were being developed, scientists had very little experience using mRNA vaccines in pregnant women, said Dr. Jacqueline Miller, a senior vice president involved in vaccine research at Moderna.

“When you study anything in pregnant women, you have two patients, the mom and the unborn child,” Miller said. “Until we had more safety data on the platform, it wasn’t something we wanted to undertake.”

But Offit notes that vaccines have a strong record of safety in pregnancy and sees no reason to have excluded pregnant people. None of the vaccines currently in use — including the chickenpox and rubella vaccines, which contain live viruses — have been shown to harm fetuses, he said. Doctors routinely recommend that pregnant people receive pertussis and flu vaccinations.

Offit, the co-inventor of a rotavirus vaccine, said that some concerns about vaccines stem from commercial, not medical, interests. Drugmakers don’t want to risk that their product will be blamed for any problems occurring in pregnant people, even if coincidental, he said.

“These companies don’t want bad news,” Offit said.

In the United States, health officials typically would have told expectant mothers not to take a vaccine that was untested during pregnancy, said Offit, a member of a committee that advises the FDA on vaccines.

Due to the urgency of the pandemic, health agencies instead permitted pregnant people to make up their own minds about vaccines without recommending them.

Women’s medical associations were also hampered by the lack of data. Neither the American College of Obstetricians and Gynecologists nor the Society for Maternal-Fetal Medicine actively encouraged pregnant people to be vaccinated until July 30, after the first real-world vaccine studies had been published. The CDC followed suit in August.

“If we had had this data in the beginning, we would have been able to vaccinate more women,” said Dr. Kelli Burroughs, the department chairman of obstetrics and gynecology at Memorial Hermann Sugar Land Hospital near Houston.

Yet anti-vaccine groups wasted no time in scaring pregnant people, flooding social media with misinformation about impaired fertility and harm to the fetus.

In the first few months after the covid vaccines were approved, some doctors were ambivalent about recommending them, and some still advise pregnant patients against vaccination.

An estimated 67% of pregnant people today are fully vaccinated, compared with about 89% of people 65 and older, another high-risk group, and 65% of Americans overall. Vaccination rates are lower among minorities, with 65% of expectant Hispanic mothers and 53% of pregnant African Americans fully vaccinated, according to the CDC.

Vaccination is especially important during pregnancy, due to increased risks of hospitalization, ICU admission and mechanical ventilation, Burroughs said. A study released in February from the National Institutes of Health found that pregnant people with a moderate to severe covid infection also were more likely to have a C-section, deliver preterm, or develop a postpartum hemorrhage.

Black moms such as Slade were already at higher risk of maternal and infant mortality before the pandemic, due to higher underlying risks, unequal access to health care, and other factors. Covid has only magnified those risks, said Burroughs, who has persuaded reluctant patients by revealing that she had a healthy pregnancy and child after being vaccinated.

Slade said she has never opposed vaccines and had no hesitation about receiving other vaccines while pregnant. But she said she “just wasn’t comfortable” with covid shots.

“If there had been data out there saying the covid shot was safe, and that nothing would happen to my baby and there was no risk of birth defects, I would have taken it,” said Slade, who has had Type 2 diabetes for 12 years.

Working at Warp Speed

Government scientists at the NIH were concerned about the risk of covid to pregnant people from the very beginning and knew that expectant moms needed vaccines as much or more than anyone else, said Dr. Larry Corey, a leader of the COVID-19 Prevention Network, which coordinated covid vaccine trials for the federal government.

But including pregnant volunteers in the larger vaccine trials could have led to interruptions and delays, Corey said. Researchers would have had to enroll thousands of pregnant volunteers to achieve statistically robust results that weren’t due to chance, he said.

Pregnancy can bring on a wide range of complications: gestational diabetes, hypertension, anemia, bleeding, blood clots, or problems with the placenta, for example. Up to 20% of people who know they’re pregnant miscarry. Because researchers would have been obliged to investigate any medical problem to make sure it wasn’t caused by one of the covid vaccines, including pregnant people might have meant having to hit pause on those trials, Corey said.

With death tolls from the pandemic mounting, “we had a mission to do this as quickly and as thoroughly as possible,” Corey said. Making covid vaccines available within a year “saved hundreds of thousands of lives.”

The first data on covid vaccine safety in pregnancy was published in April, when the CDC released an analysis of nearly 36,000 vaccinated pregnant people who had enrolled in a registry called V-safe, which allows users to log the dates of their vaccinations and any subsequent symptoms.

Later research showed that covid vaccines weren’t associated with increased risk of miscarriage or premature delivery.

Dr. Brenna Hughes, a maternal-fetal medicine specialist and member of the American College of Obstetricians and Gynecologists’ covid expert group, agrees that adding pregnant people to large-scale covid vaccine and drug trials may have been impractical. But researchers could have launched parallel trials of pregnant women, once early studies showed the vaccines were safe in humans, she said.

“Would it have been hard? Everything with covid is hard,” Hughes said. “But it would have been feasible.”

The FDA requires that researchers perform additional animal studies — called developmental and reproductive toxicity studies — before testing vaccines in pregnant people. Although these studies are essential, they take five to six months, and weren’t completed until late 2020, around the time the first covid vaccines were authorized for adults, said Dr. Emily Erbelding, director of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases, part of NIH.

Pregnancy studies “were an afterthought,” said Dr. Irina Burd, director of Johns Hopkins’ Integrated Research Center for Fetal Medicine and a professor of gynecology and obstetrics. “They should have been done sooner.”

The NIH is conducting a study of pregnant and postpartum people who decided on their own to be vaccinated, Erbelding said. The study is due to be completed by July 2023.

Janssen and Moderna are also conducting studies in pregnant people, both due to be completed in 2024.

Pfizer scientists encountered problems when they initiated a clinical trial, which would have randomly assigned pregnant people to receive either a vaccine or placebo. Once vaccines were widely available, many patients weren’t willing to take a chance on being unvaccinated until after delivery.

Pfizer has stopped recruiting patients and has not said whether it will publicly report any data from the trial.

Hughes said vaccine developers need to include pregnant people from the very beginning.

“There is this notion of protecting pregnant people from research,” Hughes said. “But we should be protecting patients through research, not from research.”

Recovering Physically and Emotionally

Slade still regrets being deprived of time with her children while she fought the disease.

Being on a ventilator kept her from spending those early weeks with her newborn, or from seeing her 9-year-old daughter, Zoe.

Even when Slade was finally able to see her son, she wasn’t able to tell him she loved him or sing a lullaby, or even talk at all, due to a breathing tube in her throat.

Today, Slade is a strong advocate of covid vaccinations, urging her friends and family to get their shots to avoid suffering the way she has.

Slade had to relearn to walk after being bedridden for weeks. Her many weeks on a ventilator may have contributed to her stomach paralysis, which often causes intense pain, nausea and even vomiting when she eats or drinks. Slade weighs 50 pounds less today than before she became pregnant and has resorted to going to the emergency room when the pain is unbearable. “Most days, I’m just miserable,” Slade said.

Her family suffered, as well. Like many babies born prematurely, Tristan, now nearly 9 months old and crawling, receives physical therapy to strengthen his muscles. At 15 pounds, Tristan is largely healthy, although his doctor said he has symptoms of asthma.

Slade said she would like to attend family counseling with Zoe, who rarely complains and tends to keep her feelings to herself. Slade knows her illness must have been terrifying for her little girl.

“The other day she was talking to me,” Slade said, “and she said, ‘You know, I almost had to bury you.’”

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Are Changes in Your Blood Pressure a Side Effect of Medicine?

High blood pressure is often called a “silent killer,” because, unless you’re having your blood pressure measured regularly, you probably won’t know you have it. It is critical to make sure you don’t have high blood pressure, because it raises your risk for heart attack and stroke. 

Nearly half of all US adults have high blood pressure To counter this  trend, health professionals often advise us to eat healthier and exercise more frequently. Sometimes, though, high blood pressure has little to do with our habits and more to do with the prescription pad. Changes in blood pressure—both higher and lower—can be a side effect of extremely common medications like Advil and Motrin (ibuprofen) and antidepressants.

Common Culprits

Many drugs alter blood pressure, whether or not they’re designed to do so. One class of drugs that raise blood pressure is ACE (angiotensin-converting enzyme) inhibitors. Here are some of the other most common culprits.

 

These Can Raise Blood Pressure

Decongestants

Caffeine

Corticosteroids

NSAIDS

Oral contraceptives

Serotonin norepinephrine reuptake inhibitors (SNRIs)

 

These Can Lower Blood Pressure

Diuretics

Opioids

Drugs for Parkinson’s disease, such as Mirapex (pramipexole) or those containing L-Dopa (levodopa)

 

These Can Either Raise or Lower Blood Pressure

Alcohol

Monoamine oxidase inhibitors (MAOIs) for depression

Selective serotonin reuptake inhibitors (SSRIs)

 

Antidepressants

Depression increases the risk for cardiovascular disease. The neurotransmitters in our brain that fuel our energy levels, moods and motivation have roles all over our bodies. They circulate throughout our bodies and can interact with our blood vessels and organs. While it’s not a frequent side effect, many of these drugs can also mess with your blood pressure in either direction.

There are four main categories of antidepressants, and all of them can alter your blood pressure. They are monoamine oxidase inhibitors (MAOIs), such as Marplan (isocarboxazid) and Nardil (phenelzine) and selective serotonin reuptake inhibitors (SSRIs), such as Prozac (fluoxetine) and Zoloft (sertraline), can actually raise or lower your blood pressure. Some serotonin norepinephrine reuptake inhibitors (SNRIs), such as Effexor XR (venlafaxine) and Cymbalta (duloxetine) can cause dangerously high blood pressure. Tricyclic antidepressants, such as Tofranil (imipramine) and Pamelor (nortriptyline) are more likely to lower your blood pressure, but can raise it as well.

The SNRI venlafaxine is one of the most likely to lead to dangerous spikes in blood pressure and should not be prescribed for those at high risk. While most SSNRIs are tied to increased blood pressure, one drug in this category, Edronax (reboxetine), has been linked to both heightened and reduced blood pressure.

Caffeine

Caffeine is a known stimulant that can raise your blood pressure for about three to four hours after you consume it.

Corticosteroids

Corticosteroids, such as Delticot (prednisone), are often prescribed for inflammatory diseases like rheumatoid arthritis. They bring about myriad side effects, including an increase in fluid retention, which can raise blood pressure.

Decongestants

Decongestants like Afrin (oxymetazoline) or Sudafed (phenylephrine) work by constricting your blood vessels to reduce swelling that causes congestion. At the same time, narrower blood vessels carrying the same amount of blood will increase blood pressure.

NSAIDS

Ingesting one dose of NSAIDS is unlikely to increase your blood pressure. Taken regularly over time, they may cause your body to hold on to water and sodium, which can increase your blood pressure and stress your kidneys. 

Levodopa

For patients with Parkinson’s disease, low blood pressure, especially when going from sitting to standing, can be both a symptom of the disease or a side effect of such treatments as Inbrijia (levodopa).

What’s a Healthy Blood Pressure?

Your healthcare provider measures your blood pressure during regular appointments, but you can also measure it on your own at home. Blood pressure is a ratio of two numbers: the top number, your systolic pressure, is the highest force your blood exerts on the walls of your arteries during a single heartbeat; the bottom number, diastolic pressure, is the lowest amount of force. A healthy blood pressure is 120/80 mmHg (millimeters of mercury), meaning systolic pressure of less than 120 and diastolic pressure of less than 80. 

Because changes in blood pressure aren’t always as easy to notice as more common side effects like nausea, it’s crucial to keep a close watch and regularly monitor your blood pressure, especially if you’re at risk. “There are many medications, both prescription and over-the-counter, that can cause either high or low blood pressure,” says Kelly Johnson-Arbor, MD, co-medical director of the National Capital Poison Center. She emphasizes that many drugs, supplements and conditions can alter your blood pressure when they interact with each other. After taking medication,  it’s crucial to contact your physician if you notice any symptoms. She adds: “You can always contact poison control by clicking on www.poison.org or by calling 1-800-222-1222, if you notice unwanted or strange symptoms after taking medications or supplements.” 

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Off-Label: Can Drugs Developed For Other Diseases Treat COVID-19?

Early in 2022, the FDA granted emergency use authorization to two antiviral drugs to treat COVID-19: Lagevrio (molnupiravir) and Paxlovid (nirmatrelvir and ritonavir). These treatments aren’t 100% effective, though they are more effective the sooner they’re prescribed, so it’s been crucial for scientists to continue to study other drugs and combinations to determine the best treatments—old and new—for COVID-19.

Since the start of the COVID-19 pandemic, researchers and the biopharmaceutical industry have been working to determine if available medications can treat COVID-19, knowing that existing treatments would be faster and easier to get to people who need them than newly-designed drugs.

Some of the treatments they’ve tried have failed, while others have proven useful in certain scenarios, like if you’re hospitalized. Researchers have put together the data,  and one group has created a registry of more than 350 drugs being tested to treat the disease or its symptoms. Additionally, on March 15, 2021, the Food and Drug Administration (FDA) launched the FAERS (FDA Adverse Event Reporting System) public dashboard. There, patients, healthcare providers and manufacturers can report and review adverse events associated with drugs and therapies that have received emergency use authorizations (EUAs) for COVID-19. Vaccines are not included; adverse reactions to vaccines are reported through the Vaccine Adverse Event Reporting System (VAERS.)

Here are the highlights of what researchers have found:.

A Two-Pronged Approach

One approach to treat a COVID-19-related illness is to find medications that slow down — or even stop — the virus’s ability to reproduce. This could shorten the illness’ duration and prevent it from becoming severe or critical.

Researchers are also investigating drugs that reduce the body’s immune response in the critical stages of illness. An overzealous immune response can cause inflammation that damages cells and organs throughout the body.

There isn’t enough scientific evidence about the safety or effectiveness of most of these drugs for them to have garnered FDA approval to treat COVID-19. Larry Sasich, PharmD, MPH, a consultant for the FDA and the Saudi Arabian Food and Drug Authority, and co-author of Worst Pills, Best Pills, also pointed out that, for the most part, we only really know about side effects in patients who don’t have COVID-19.

Be sure to talk with your doctor about any medication that you’re considering using to treat COVID-19. Not only is there the possibility for dangerous side effects, but there are also potential drug interactions to consider that require medical supervision.

Potentially Promising Treatments

Here’s a look at some of the drugs that scientists are researching to see if they could be effective in treating COVID-19-related illnesses.

Antacid

What it’s currently used for: Pepcid (famotidine) is currently used as a daily pill to prevent acid reflux. It reduces your production of stomach acid, and researchers believe, of certain inflammatory proteins called interferons.

Clinical Trials: Some early studies suggested the drugs helped patients who were hospitalized but another large study contradicted those findings. Researchers published the only randomized clinical trial in the journal Gut, in February 2022, which showed that high doses of the drug (80mg, while a typical pill contains 20mg) taken three times a day for up to 14 days reduced the duration of symptoms in non-hospitalized patients. The study only included 55 patients and larger studies are required to validate these results.

Known serious side effects: Famotidine is generally considered safe when used short-term, though longer term use and higher doses do come with a variety of serious side effects such as an elevated risk for kidney problems and cognitive impairment.

Antidepressants

Fluvoxamine

What it’s currently used for: Fluvoxamine is a selective serotonin reuptake inhibitors (SSRI) commonly used to treat obsessive-compulsive disorder (OCD.) SSRIs are also used to treat depression. It increases the availability of a the neurotransmitter serotonin. Fluvoxamine also reduces inflammation, which is how it may help with COVID-19.

Clinical trials: There were several small trials early in the pandemic that suggested the drug might help reduce hospitalization and death, but on October 27, 2021, a much larger study of 1500 patients was published in The Lancet. The trial showed that the drug reduced hospitalizations by two-thirds, when taken as directed. There was only one death in the fluvoxamine group, compared to 12 in the placebo group.

Known serious side effects: The phrase “taken as directed” was crucial here, as 84 patients in the trial discontinued using the drug due to intolerability. (However, 64 also stopped using the placebo as well.) When these patients were accounted for, fluvoxamine only decreased hospitalizations by one-third. The most common side effects are constipation, headache, difficulty sleeping and fatigue. However, there are many concerning less common side effect such as feeling of constant movement of self or surroundings, abdominal pain, twitching, trouble breathing, trouble urinating, blurred vision and bruising. Researchers told the New York Times that the intolerability suggested that the researchers may not have found the ideal dose yet.

IL-6 Receptor Inhibitors

The IL-6 (interleukin-6) receptor inhibitors tocilizumab and sarilumab are both injections and “they are quite potent in reducing inflammation,” said Hana Akselrod, MD, an assistant professor of medicine in infectious diseases at the George Washington University School of Medicine and Health Sciences in March 2020.

How IL-6 inhibitors could help COVID-19 patients: The theory is that these medications “try to block parts of that severe immunologic inflammatory cascade in order to reduce the severity of the pneumonia that happens after the virus (COVID-19) has already caused the infection,” said Akselrod.

“There do appear to be some data that suggest that [Il-6 inhibitors] might be effective as adjuncts to treatment in patients with severe COVID-19 pneumonia, reducing some of the inflammation and some of the other complicating factors, hopefully, to improve oxygenation,” said Michael Klepser, PharmD, FCCP, a professor at Ferris State University’s College of Pharmacy, in March. “They’re not going to necessarily cure the virus, but they may help patients improve clinically.”

Tocilizumab (Actemra/RoActemra)

What it’s currently used for: Tocilizumab is FDA-approved to treat active rheumatoid arthritis (RA), giant cell arteritis, juvenile idiopathic arthritis and cytokine release syndrome. It works by decreasing the overactive inflammatory response found in these conditions.

Clinical trials: Researchers have conducted several trials yielding mixed results. The National Institutes of Health (NIH) recommended against their use this summer. However, a new study posted on a preprint server suggested that both tocilizumab and sarilumab may reduce the death rate of patients in the intensive care unit from 36% to 27%. Scientists note that the main difference between this study and previous ones is that the current study was conducted only in critically ill patients.

The NIH now recommends that the drug be used in combination with dexamethasone to treat certain hospitalized patients with severe COVID-19.

Known serious side effects: Tocilizumab has multiple potential side effects, the most consequential is an increased risk of developing serious infections that can lead to hospitalization or death. Because of that risk, tocilizumab has a black box warning. “A boxed warning is the most serious warning that the FDA can require in the professional product label for a drug,” said Sasich. “Usually, it involves deaths in human beings.” Other severe adverse reactions include tears in the stomach or intestines, liver issues, low platelet count, higher blood-cholesterol levels, low neutrophil (white blood cell) count, allergic reactions and an increased risk of cancer.

Sarilumab (Kevzara)

What it’s currently used for: Sarilumab (Kevzara) is FDA-approved to treat active RA, particularly in people who haven’t responded to other medications for RA or who can’t use other types of medication.

Clinical trials: Early on, researchers conducted several trials yielding mixed results. However, a study posted on a preprint server in January 2021 (meaning it was not yet peer-reviewed, a process used by the best publishers to ensure high-quality research was conducted) suggested that the both tocilizumab and sarilumab may reduce the mortality rate of patients in the intensive care unit from 36% to 27%. Scientists note that the main difference between this study and previous ones is that the current study was conducted only in critically ill patients.

The NIH suggests using sarilumab in combination with dexamethasone for severely ill, hospitalized COVID-19 patients when tocilizumab is unavailable.

Known serious side effects: Sarilumab, too, has a black box warning about an increased risk of developing serious infections that can lead to hospitalization or death. It also has the same potential grave adverse reactions as tocilizumab, including tears in the stomach or intestines, liver issues, low platelet count, higher blood-cholesterol levels, low neutrophil (white blood cell) count, allergic reactions and an increased risk of cancer.

Antiviral Drugs

Remdesivir

Remdesivir was originally formulated to fight the Ebola virus. However, it was found to be basically ineffective against Ebola during the 2019 outbreak in the Democratic Republic of the Congo.

What it’s currently used for: Remdesivir works by inhibiting a virus’ ability to replicate, but it wasn’t approved to treat any type of condition or disease prior to the pandemic.

Clinical trials: Remdesivir was the first (and only) drug fully approved by the FDA to treat COVID-19 in October 2020, though it had received an EUA before that in May. It was one of the drugs used to treat former President Donald Trump when he contracted the illness. Trials showed that the drug shortened recovery times from 15 to 10 days for certain hospitalized patients and that the drug was most effective in those who were receiving oxygen but were not ventilated. The NIH now recommends that the drug be used in these patients.

Known serious side effects: Not a lot of information is available for this drug because it wasn’t previously approved. “One concerning bit about it is it does have a solubilizing [dissolving] agent in it called SBECD (sulfobutylether-beta-cyclodextrin),” said Klepser. “We’ve seen that solubilizer used with other medications and sometimes in patients with renal dysfunction [it] can cause some problems because (the SBECD) can accumulate and cause kidney damage. That would be the major thing to keep an eye on.”

The NIH lists allergic reactions, nausea and liver damage as possible side effects, but it’s noted that there may be more we don’t yet know about.

How it could help COVID-19 patients: In 2017, researchers found that remdesivir was effective against many different coronaviruses — including the ones that cause severe acute respiratory syndrome (SARS) — in both mice and in cell cultures.

“The idea is treating with remdesivir would prevent the viral infection from becoming established and would also shorten its duration once it’s already happening,” said Akselrod.

Ritonavir and Lopinavir (Kaletra)

Ritonavir and lopinavir are antivirals used in a combination drug called Kaletra.

What it’s currently used for: Kaletra is FDA-approved to treat human immunodeficiency virus (HIV). This medication blocks the virus’s ability to copy its genetic material, said Akselrod. “This is a medication we’ve been using for many, many, many years to treat HIV, and it’s a potent and effective antiviral, but for a virus that’s not in the same family as COVID-19,” she said.

Clinical trials: Trials have not demonstrated that the drug helps patients with COVID-19. The NIH recommends against their use for COVID-19.

Known serious side effects: There are a number of other medications that shouldn’t be taken with Kaletra because of the risk of acute drug interactions. Kaletra use can also lead to pancreatitis, liver damage, heart rhythm abnormalities, increased cholesterol levels and new or worsened diabetes.

Anti-Parasitic Drugs

Chloroquine and Hydroxychloroquine

What they’re currently used for: Both chloroquine and hydroxychloroquine medications are FDA-approved to treat and prevent malaria. “Remember that malaria is not a virus or a bacterium, it’s a parasite,” said Sasich. Because parasites have cells that are similar to human cells, a drug that’s used to treat a parasitic infection like malaria may cause more serious adverse effects, he says.

Chloroquine is also approved to treat amoebiasis, a gastrointestinal infection caused by an amoeba. Hydroxychloroquine is approved for systemic lupus erythematosus and RA in patients whose symptoms haven’t improved using other medications.

Clinical trials: On March 30, 2020, the FDA granted chloroquine and hydroxychloroquine an EUA for the treatment of COVID-19. While clinical trials were still ongoing, the approval was made so that the government could add it to the Strategic National Stockpile and it would be available for hospitals to request and to supply for clinical trials. However, in June, after the trials ended and demonstrated that the drug did not benefit patients with COVID-19, the authorization was revoked.

In a November 2020 study in the New England Journal of Medicine, scientists reported that the drug also does not prevent COVID-19 when taken after close contact with an infected person.

Known serious side effects: Chloroquine’s potential adverse effects include cardiomyopathy (heart muscle disease) that can result in heart failure, heart rhythm abnormalities, severe hypoglycemia (low blood sugar), permanent eye damage, muscle weakness, gastrointestinal distress, neuropsychiatric disorders and immune system dysregulation. Using chloroquine with certain other medications can lead to serious drug interactions.

Hydroxychloroquine has a risk of similar serious side effects, such as permanent eye damage, cardiac effects like cardiomyopathy with a risk for heart failure and heart rhythm abnormalities, severe hypoglycemia and muscle atrophy. It can also cause suicidal behavior. Other grave effects have been reported as well, including disorders of the blood, heart, ear, eye, immune system, metabolism and skin.

How antimalarials were thought to help COVID-19 patients: Akselrod said the theory was “essentially (that) those drugs would make the cell less hospitable to the virus by interfering with some of the mechanisms that are involved in both the virus entering the cell and then possibly with the inflammation that occurs around the infection.”

Like remdesivir, chloroquine and hydroxychloroquine have been found to be effective against coronaviruses in cell cultures, including ones that cause SARS, but not in humans with COVID-19.

Potential risks for COVID-19 patients: Not everyone can take these drugs, Akselrod said. “Chloroquine and hydroxychloroquine can cause quite severe poisoning and even fatalities, if they’re not taken under the supervision of a doctor or if they’re ingested in the wrong dose or by someone with a heart condition that’s predisposed to an irregular rhythm. These drugs can trigger an unstable heart rhythm, which can cause the heart to stop, which is why it’s so concerning that right now there seems to be a worldwide rush on these drugs.”

“The major concerns with these medications are their toxicities and that when they’re used, some patients experience very severe side effects, including cardiovascular conduction abnormalities and agranulocytosis, which is kind of like wiping out your immune system,” Klepser said.

People who hoarded these drugs or took them unsupervised became a problem, too, said Akselrod. “This is in the context of an unprecedented global emergency, and it’s quite understandable if people are scared and trying to reach for anything that’s available that we think might help. But people who depend on these drugs to control their lupus or [RA] find themselves unable to refill their prescriptions. They’re at risk of having their disease flare up and force them to go to the hospital at a time when it’s very unsafe for them to be doing that and when they should be isolating at home and trying to avoid infection at all costs.”

Ivermectin

What it’s currently used for: Ivermectin is used to treat parasitic worms. It comes as pills or as topical creams to treat head lice and other skin conditions. One formulation is commonly used in dogs to prevent heartworm. The FDA has warned consumers not to self-treat with ivermectin, especially with formulations meant for animals.

Clinical trials: In June 2020, researchers published a study showing that the drug could prevent the virus that causes COVID-19 from replicating in Petri dishes. If it worked the same way in humans, this would be likely to significantly reduce symptom severity. Some doctors started prescribing it to COVID-19 patients, especially in Latin America, but the NIH warned that, to be effective, it may be required to use incredibly high doses (up to 100 times the usual anti-parasitic dose), which would create new safety concerns. The NIH for now has concluded that there was not enough evidence to recommend for or against its use. Several clinical trials have tested the drug in COVID-19 patients, but results have been inconsistent.

One popular study that supported the drug’s use was later withdrawn due to poor methodology and plagiarism. A separate trial, the Together clinical trial, stopped testing ivermectin after interim analyses suggested the drug provided no benefit.

A Cochrane Review published on July 28, 2021, determined that there was not enough evidence to demonstrate that ivermectin is effective against COVID-19, and that almost all completed studies were of low quality.

Some clinical trials are still ongoing, and organizations, like the World Health Organization (WHO) and the Infectious Disease Society of America, say that only patients enrolled in these trials should be taking ivermectin for COVID-19. The drug’s manufacturer Merck does not recommend it be used to treat the disease.

Known serious side effects: Calls to poison control and emergency room visits by patients who have ingested ivermectin skyrocketed over the summer of 2021, according to a bulletin from the American Association of Poison Control Centers. The drug can cause headaches, dizziness, muscle pain, rapid heart rate, chest discomfort, shaking, nausea and diarrhea. Rarely, patients can also have severe allergic reactions.

Many people have tried to use formulations designed for horses and cows. These are far more potent than the drugs prescribed to humans and can cause extremely dangerous side effects like hallucinations and seizures, according to the Centers for Disease Control and Prevention (CDC).

Interactions with other drugs: Blood thinners and ivermectin strengthen each other’s impacts, increasing the likelihood of dangerous side effects. The drug can also interact with supplements like St. John’s wort, experts told NPR.

Convalescent Plasma

What it’s currently used for: In August 2021, the FDA announced an EUA for convalescent plasma. It’s thought that since the blood of patients who have recovered from COVID-19 should be filled with antibodies, giving a portion of it to current patients should help them recover. It’s the same idea behind the monoclonal antibodies, which are mixtures of antibodies made in a lab rather than taken from a recovered person’s blood.

“This approach predates a lot of the current science on vaccines in immunology and the antibody response,” Akselrod said. “For more than 100 years, people have tried this approach — us[ing] the blood of people recovered from an infectious disease to cure those still suffering from it. The promise is that there is historic experience with it. The downside is, of course, we don’t know how effective it will be for this virus, in part because there might be slight variations in the virus that circulates across the big population. Viruses do mutate and change their surface appearance in ways that try to evade the immune system.”

Clinical trials: Studies have been mixed. In October, the NIH wrote that there was insufficient evidence to recommend the use of convalescent plasma. However, a study published on January 6, 2021, in the New England Journal of Medicine showed that the treatment can reduce the risk of severe illness when given to patients over 65 within 72 hours of COVID-19 symptoms starting.

Most studies so far have not shown a benefit of using convalescent plasma. Additionally, monoclonal antibodies are being used regularly instead. In March 2021, the FDA halted a trial because, while the treatment appears to be safe, it showed no benefit to patients with mild symptoms.

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Know the Dangers of Diabetes Drugs

✅ This article was reviewed and approved by Terry Graedon, member of our MedShadow Medical Advisory Board.

When Ron Carlson died on his motorcycle at 66, it wasn’t a slippery road or a distracted driver that led to his demise. It was hypoglycemia, according to the medical examiner who reviewed his death. Carlson, a diabetic, had been prescribed medication to lower his blood sugar, a job the drugs did too well. In Carlson’s case, it led to hypoglycemia that caused him to stumble, clutch the bike’s throttle for balance and then be flung across a restaurant parking lot.

The fact that diabetes medicines have side effects should come as no surprise, but the lack of attention to rare and especially dangerous side effects of diabetes drugs, such as hypoglycemia and ketoacidosis, may be. A series published on Reuters in November 2021 alleges that pharmaceutical companies, like Johnson & Johnson, which make the drugs, had known about these potential complications years before they were made public.

Type 1 and Type 2 diabetes are both characterized by high blood sugar, also known as hyperglycemia, that over time can damage organs like the heart, liver and kidneys. Thus, the main goal of treating diabetes is to lower your blood sugar. Some people may be able to control their diabetes with lifestyle changes, but many others are prescribed medications long-term to lower their blood-sugar levels. Here’s what you need to know.

Hypoglycemia 

In addition to alleging that companies ignored dangerous side effects of diabetes medicines, the Reuters articles report that pharmaceutical companies, rather than doctors, are behind the push for patients to aim for a specific A1C. A1C (also called HBA1c or glycosylated hemoglobin) is a blood test for those with Type 2 diabetes or with prediabetes, which measures the average blood glucose, or blood sugar, level over three months. The American Diabetic Association and some diabetes drug manufacturers support a goal of maintaining a blood-sugar level of under 7% for three consecutive months, but the association isn’t devoid of connections to pharma. The organization has several corporate sponsors, including Eli Lilly, which donates more than $1 million a year. The company makes several diabetes drugs, including Trulicity (dulaglutide) and Jardiance (empagliflozin), which are heavily advertised on TV. 

While the 7% A1C goal is appropriate for most patients, it may be too aggressive for others, especially patients over the age of 65. It could lead these patients to experience dangerous hypoglycemia as a result of attempting to lower their blood-sugar levels or even result in death.

Diabetics measure their blood-sugar levels regularly using blood-glucose monitors or finger-prick tests. When you visit your doctor, he or she will review your A1C.

Early symptoms of hypoglycemia include:

• Anxiety
• Irregular heartbeat
• Paleness
• Sweating
• Tingling or numb lips or tongue

If hypoglycemia goes unaddressed, more dangerous symptoms can occur. They are:

• Confusion
• Blurred vision
• Loss of consciousness
• Seizure

If you experience hypoglycemia, your doctor may need to reduce your dose of diabetes medication. Exercising more or eating less than you usually do can also trigger hypoglycemia in patients with diabetes.

Ketoacidosis

Another risk that was tied specifically to the diabetes drug Invokana (canagliflozin), according to Reuters, is diabetic ketoacidosis, an increase in acids in the blood called ketones, caused by prolonged high blood sugar. Untreated ketoacidosis can kill you.

However, it’s not only Invokana that causes problems. In a 2020 study in the Annals of Internal Medicine, people given SGLT-2 inhibitors, including Jardiance and Farxiga (dapagliflozin), had triple the risk of developing diabetic ketoacidosis compared to those given DPP-4 inhibitors, such as Tradjenta (linagliptin) and Januvia (sitagliptin). However, the researchers note that the overall risk of ketoacidosis remains low, even in those receiving SGLT-2 inhibitors.

Symptoms of ketoacidosis include:

• Nausea or stomach pain, vomiting
• Excessive thirst and urination
• Fruit-scented breath
• Confusion
• Unusual fatigue
• Shortness of breath

Diet and exercise can help patients with diabetes reduce or discontinue the use of drugs. For many, medication will always be an important aspect of their overall care. Nonetheless, it’s crucial to tell your healthcare provider how you feel and what treatment goals are the best ones for you.

 

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About Shoulder Pain Post-Vaccination: When Do I Need to See a Doctor?

When MedShadow started collecting comments for its side effects of COVID-19 vaccine tracker, what quickly emerged is that COVID-19 shots are also associated with substantial arm pain. That result was so common that we published a separate article about the redness, pain and rashes that sometimes followed the jabs. In most cases, this was a typical response to the vaccine, which cleared up within a few days. Injection-site reactions, including redness and pain, were the most reported side effect in the COVID vaccine trials, affecting more than 84% of patients who received a Pfizer shot. On occasion, though, the reactions appeared a week later and lasted about a week.

In rare instances, arm pain after a vaccine can be something other than a normal immune reaction. If a vaccine—any vaccine—is administered too high up on the arm, it can get into the bursa, a fluid-filled sac that protects your joints. If that’s the case, it causes the immune system to attack your shoulder. This translates into pain and decreased range of motion that can last for weeks or even much longer. 

In our article about arm pain after COVID shots, we received a number of comments complaining of longer-lasting pain. *In July, Jim, for example, wrote, “Hi JoJo, Got my second Moderna shot 10 Feb and my arm hurt quite a bit until about three weeks ago. Have not felt any pain for last three weeks or so and am hoping that those side effects are going away. I do have a little arthritis in both shoulders, but had some of that previously. The pain I had after the second shot was like a rotator cuff injury and quite painful at times. I used a heating pad a lot for a while. Hang in there. I believe it will get better for you. jim in Va.”

* Stacey Edmonds described similar issues, writing, “I have the SAME issues. It’s been 5 weeks since my Pfizer vaccine & I can barely lift my arm above my head. I have pain when lifting my toddler or doing the smallest of things. I can’t lie on my left side without pain & I struggle doing arm exercises at the gym. I have random shooting pains with the slightest of movement. I really hope this isn’t permanent 🙁”

The term shoulder injury related to vaccine administration (SIRVA), gained attention over the last decade as patients filed lawsuits with the National Vaccine Injury Compensation Program. In 2015, it was added to the vaccine injury table, which makes it easier for patients who experience it to get compensation. It’s not so much a definitive medical diagnosis as it is a legal term describing a range of possible injuries due to inflammation in the shoulder connected to receiving the vaccine incorrectly. It’s more common in women than in men, and in adults than in children, but other factors, like Body Mass Index (BMI), don’t seem to play a role in the likelihood that you may experience SIRVA.

Why Shots Are Given in the Shoulder

Most vaccines are injected into muscles because the tissue contains substantial immune cells that will recognize the antigen in the vaccine and mount a response. To maintain protection, these cells need to bring the antigens to our lymph nodes—tissues throughout the body where antibodies are formed—where our immune cells mature and develop “memory.”

The deltoid muscle, the large, upside down triangular muscle near the top of your shoulder, is an ideal choice. This muscle is not only relatively easy to access (just roll up a sleeve), but it is also situated a short distance from the lymph nodes under your arms.

In most cases, SIRVA is caused by a vaccine being administered too high on the shoulder, which allows the substance to be released into the shoulder joint rather than into the muscle. The vaccine is designed to elicit an immune response, but doing so in the bursa can cause painful inflammation and tissue damage. However, if the shot is placed too low, it’s also possible to hit a nerve and cause neuropathy or numbness. 

SIRVA Treatments

Most shoulder pain associated with shots resolves on its own over time, days or weeks. Treatments for SIRVA are the same as those for other shoulder injuries and usually aim to reduce the inflammation to your shoulder. They include: 

• Icing and heating the shoulder regularly
• Physical therapy
• Over-the-counter (OTC) anti-inflammatory drugs like Advil or Motrin (ibuprofen)
• Corticosteroid injections

SIRVA may also aggravate an existing shoulder injury, such as a previously damaged rotator cuff. If this happens and symptoms fail to subside, you may need surgery to treat the underlying injury.

What to Do If You Think You Have SIRVA

If your arm or shoulder pain lasts more than a few days after getting a vaccine, you should talk to your primary care provider. If physical therapy and corticosteroid injections don’t relieve the pain, you may be referred to an orthopedic surgeon who specializes in injuries like rotator cuff injuries or tendonitis. The doctor may order an ultrasound and determine a treatment plan. The ultrasound can help a physician understand the injured area’s location and extent of the damage, but can’t tell you if the cause is improper vaccine administration or another type of injury.

Luckily, many patients recover from a sore arm or shoulder after a few weeks of applying ice and taking OTC anti-inflammatory drugs. Nonetheless, if your shoulder hurts for more than a week after a vaccine and limits your ability to complete common tasks like reaching over your head, it’s time to see a doctor.

*MedShadow has chosen not to edit these comments.

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In research studies and in real life, placebos have a powerful healing effect on the body and mind

Did you ever feel your own shoulders relax when you saw a friend receive a shoulder massage? For those of you who said “yes,” congratulations, your brain is using its power to create a “placebo effect.” For those who said “no,” you’re not alone, but thankfully, the brain is trainable.

Since the 1800s, the word placebo has been used to refer to a fake treatment, meaning one that does not contain any active, physical substance. You may have heard of placebos referred to as “sugar pills.”

Today, placebos play a crucial role in medical studies in which some participants are given the treatment containing the active ingredients of the medicine, and others are given a placebo. These types of studies help tell researchers which medicines are effective, and how effective they are. Surprisingly, however, in some areas of medicine, placebos themselves provide patients with clinical improvement.

As two psychologists interested in how psychological factors affect physical conditions and beliefs about mental health, we help our patients heal from various threats to well-being. Could the placebo effect tell us something new about the power of our minds and how our bodies heal?

Real-life placebo effects

Today, scientists define these so-called placebo effects as the positive outcomes that cannot be scientifically explained by the physical effects of the treatment. Research suggests that the placebo effect is caused by positive expectations, the provider-patient relationship and the rituals around receiving medical care.

Depression, pain, fatigue, allergies, irritable bowel syndrome, Parkinson’s disease and even osteoarthritis of the knee are just a few of the conditions that respond positively to placebos.

Despite their effectiveness, there is stigma and debate about using placebos in U.S. medicine. And in routine medical practice, they are rarely used on purpose. But based on new understanding of how non-pharmacological aspects of care work, safety and patient preferences, some experts have begun recommending increasing the use of placebos in medicine.

The U.S. Food and Drug Administration, the organization that regulates which medicines are allowed to go to the consumer market, requires that all new medicines be tested in randomized controlled trials that show they are better than placebo treatments. This is an important part of ensuring the public has access to high-quality medications.

But studies have shown that the placebo effect is so strong that many drugs don’t provide more relief than placebo treatments. In those instances, drug developers and researchers sometimes see placebo effects as a nuisance that masks the treatment benefits of the manufactured drug. That sets up an incentive for drug manufacturers to try to do away with placebos so that drugs pass the FDA tests.

Placebos are such a problem for the enterprise of drug development that a company has developed a coaching script to discourage patients who received placebos from reporting benefits.

Treating depression

Prior to the COVID-19 pandemic, about 1 in 12 U.S. adults had a diagnosis of depression. During the pandemic, those numbers rose to 1 in 3 adults. That sharp rise helps explain why US$26.25 billion worth of antidepressant medications were used across the globe in 2020.

Brain-imaging studies show that the brain has an identifiable response to the expectations and context that come with placebos.

But according to psychologist and placebo expert Irving Kirsch, who has studied placebo effects for decades, a large part of what makes antidepressants helpful in alleviating depression is the placebo effect – in other words, the belief that the medication will be beneficial.

Depression is not the only condition for which medical treatments are actually functioning at the level of placebo. Many well-meaning clinicians offer treatments that appear to work based on the fact that patients get better. But a recent study reported that only 1 in 10 medical treatments sampled met the standards of what is considered by some to be the gold standard of high quality evidence, according to a grading system by an international nonprofit organization. This means that many patients improve even though the treatments they receive have not actually been proved to be better than the placebo.

How does a placebo work?

The power of the placebo comes down to the power of the mind and a person’s skill at harnessing it. If a patient gets a tension headache and their trusted doctor gives them a medicine that they feel confident will treat it, the relief they expect is likely to decrease their stress. And since stress is a trigger for tension headaches, the magic of the placebo response is not so mysterious anymore.

Now let’s say that the doctor gives the patient an expensive brand-name pill to take multiple times per day. Studies have shown that it is even more likely to make them feel better because all of those elements subtly convey the message that they must be good treatments.

Part of the beauty of placebos is that they activate existing systems of healing within the mind and body. Elements of the body once thought to be outside of an individual’s control are now known to be modifiable. A legendary example of this is Tibetan monks who meditate to generate enough body heat to dry wet sheets in 40-degree Fahrenheit temperatures.

A field called Mind Body Medicine developed from the work of cardiologist Herbert Benson, who observed those monks and other experts mastering control over automatic processes of the body. It’s well understood in the medical field that many diseases are made worse by the automatic changes that occur in the body under stress. If a placebo interaction reduces stress, it can reduce certain symptoms in a scientifically explainable way.

Placebos also work by creating expectations and conditioned responses. Most people are familiar with Pavlovian conditioning. A bell is rung before giving dogs meat that makes them salivate. Eventually, the sound of the bell causes them to salivate even when they do not receive any meat. A recent study from Harvard Medical School successfully used the same conditioning principle to help patients use less opioid medication for pain following spine surgery.

Furthermore, multiple brain imaging studies demonstrate changes in the brain in response to successful placebo treatments for pain. This is excellent news, given the ongoing opioid epidemic and the need for effective pain management tools. There is even evidence that individuals who respond positively to placebos show increased activity in areas of the brain that release naturally occurring opioids.

And emerging research suggests that even when people know they are receiving a placebo, the inactive treatment still has effects on the brain and reported levels of improvement.

Placebos are nontoxic and universally applicable

In addition to the ever-increasing body of evidence surrounding their effectiveness, placebos offer multiple benefits. They have no side effects. They are cheap. They are not addictive. They provide hope when there might not be a specific chemically active treatment available. They mobilize a person’s own ability to heal through multiple pathways, including those studied in the field of psychoneuroimmunology. This is the study of relationships between the immune system, hormones and the nervous system.

By defining a placebo as the act of setting positive expectations and providing hope through psychosocial interactions, it becomes clear that placebos can enhance traditional medical treatments.

Using placebos to help people in an ethical way

The placebo effect is recognized as being powerful enough that the American Medical Association considers it ethical to use placebos to enhance healing on their own or with standard medical treatments if the patient agrees to it.

Clinically, doctors use the principles of placebo in a more subtle way than it is used in research studies. A 2013 study from the U.K. found that 97% of physicians acknowledged in a survey having used some form of placebo during their career. This might be as simple as expressing a strong belief in the likelihood that a patient will feel better from whatever treatment the doctor prescribes, even if the treatment itself is not chemically powerful.

There is now even an international Society for Interdisciplinary Placebo Studies. They have written a consensus statement about the use of placebos in medicine and recommendations for how to talk with patients about it. In the past, patients who improved from a placebo effect might have felt embarrassed, as if their ailment were not real.

But with the medical field’s growing acceptance and promotion of placebo effects, we can envision a time when patients and clinicians take pride in their skill at harnessing the placebo response.

[Get fascinating science, health and technology news. Sign up for The Conversation’s weekly science newsletter.]

Written by Elissa H. Patterson, Clinical Assistant Professor of Psychiatry and Neurology, University of Michigan and Hans Schroder, Clinical Assistant Professor of Psychiatry, University of Michigan

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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