Patient Education

New Drug Information and Focus on Alzheimer's Disease

Coming Soon!!
Please sign up for " What Are the 7 Important Principals Every African-American and Latino Patient and Caregivers Should Know About This New Alzheimer's Drug And the New Experimental Weight Loss Drug from Eli Lilly!
https://blackchurchclinicaltrials.com/side-effects.php

Experimental drug could offer more weight loss than any drug now on the market, study finds

By Berkeley Lovelace Jr.

SAN DIEGO — An experimental drug from Eli Lilly has the potential to provide greater weight loss benefits than any drug currently on the market.

The experimental drug, retatrutide, helped people lose, on average, about 24% of their body weight, the equivalent of about 58 pounds, in a mid-stage clinical trial, the company said Monday from the American Diabetes Association's annual meeting in San Diego. The findings were simultaneously published in The New England Journal of Medicine.

If the results are confirmed in a larger, phase 3 clinical trial — which is expected to run until late 2025 — retatrutide could leapfrog another Lilly weight loss drug, tirzepatide, which experts estimated earlier this year could become the best-selling drug of all time. Tirzepatide is currently approved for Type 2 diabetes under the name Mounjaro; FDA approval of the drug for weight loss is expected this year or early next year.

The new findings, according to Dr. Shauna Levy, a specialist in obesity medicine and the medical director of the Tulane Bariatric Center in New Orleans, are “mind-blowing.”

Levy, who was not involved with the research, said the drug seems to be delivering results that are approaching the effectiveness of bariatric surgery. “It’s certainly knocking on the door or getting close,” she said.

The new study underscores the rapid upswing in recent years in the discovery of new treatments for weight loss as companies invest in a new class of medicines called GLP-1 agonists, which mimic a hormone that helps reduce food intake and appetite.

The drugs have been “transformative to say the least,” Levy said. “They’ve given so many people hope that felt sort of helpless in this fight against the disease of obesity.”

Semaglutide, the active ingredient in the highly popular Novo Nordisk drugs Ozempic and Wegovy, is a GLP-1 agonist. Lilly’s tirzepatide acts as a GLP-1 agonist and also mimics another hormone, called GIP.

Retatrutide mimics GLP-1 and GIP, plus one other hormone: glucagon. GIP is thought to improve how the body breaks down sugar; glucagon may reduce appetite and help metabolism run more efficiently.

“This can explain why retatrutide yields more effective weight loss,” said Dr. Holly Lofton, the director of the weight management program at NYU Langone Health. She was not involved with the trial, although she has previously served on an advisory board for Ozempic and Wegovy-maker Novo Nordisk.

Dr. Dan Skovronsky, Eli Lilly’s chief scientific and medical officer, told NBC News that retatrutide is attempting to harness the body’s own mechanisms that metabolize food and tell the body when to stop eating.

“We’ve taken those normal signaling molecules in your body and we’ve turned them into medicines,” Skovronsky said.

How does retatrutide compare to other weight-loss drugs?

Lilly’s phase 2 trial looked at 338 adults who were obese or overweight and were randomized to receive a placebo or one of four dosages of retatrutide. The drug was given as a weekly injection.

Participants had a body mass index, or BMI, of 27 or greater. The results published Monday did not include patients with Type 2 diabetes, a group that is also prescribed GLP-1 medications because of their effects on blood sugar levels. A separate trial is looking at retatrutide for patients with Type 2 diabetes.

After 24 weeks, patients taking the highest dose — 12 milligrams — lost, on average, 17.5% of their body weight, the equivalent of, on average, 41 pounds, according to the company. By 48 weeks, the weight loss increased to 24.2% of their body, or 57.8 pounds.

“The degree of efficacy, it was definitely striking,” said Dr. Ania Jastreboff, an obesity medicine physician scientist at Yale University School of Medicine and the lead author on the phase 2 study.

What’s more, at the end of 48 weeks the weight loss had not yet plateaued, meaning they could have potentially lost even more weight had they stayed on the medication for a longer period of time, she said.

Jucynthia Jessie, 44, of Laplace, Louisiana, participated in the trial and lost 60 pounds.

“I was totally surprised,” Jessie said. “You don’t know if you have the placebo or not, so once I started seeing the results — no one ever told me anything different — but I saw the results for myself and so I was really surprised.” (Jessie wasn't told that the trial was studying retatrutide — only that it was a study on a weight loss drug — but the research facility confirmed with NBC News.)

Jucynthia Jessie in December 2022, after she completed the trial. Courtesy Jucynthia Jessie

She’s gained back about 15 pounds in the nine months since she completed the trial, but said she still thinks the weight loss is sustainable with healthy lifestyle choices.

Weight loss in the trial seemed to happen quicker than other weight loss medications, according to Jastreboff. Novo Nordisk’s semaglutide was found to reduce body weight, on average, by around 15%, or about 34 pounds, after 68 weeks. And Lilly’s other weight loss drug, tirzepatide, was shown to reduce body weight, on average, by 22.5% on average, or about 52 pounds, after 72 weeks. To be sure, these are not direct comparisons because the drugs were not compared in a head-to-head clinical trial.

Dr. Fatima Cody Stanford, a physician specializing in obesity at Massachusetts General Hospital in Boston, said that when patients lose weight very quickly — more than 10 pounds a month — they can be at risk for developing gallstones. It’s a known side effect following bariatric surgery, she said, and would be something she would keep an eye on. In clinical trials, tirzepatide and semaglutide have also been associated with a small but slightly increased risk of gallbladder disease, including gallstones.

The speed of the weight loss seen with retatrutide was not a concern to Lofton. Rapid weight loss is usually only detrimental “if it is achieved in an overly restrictive manner, such as drinking only water or eating only cabbage,” she said.

Still, she said she wanted to see more data on how much lean body mass — that is, weight in the body that isn’t fat, including bone muscle and organs — people lose on the drug. Losing too much lean mass can cause a person’s metabolism to slow down.

The side effects of retatrutide were similar to other weight loss medications, Skovronky said. Side effects from Ozempic and Wegovy, for example, include nausea, vomiting, diarrhea and constipation. Generally, people experience those side effects as they ramp up the dosage at the start of treatment, but the side effects usually go away after prolonged use.

Who would retatrutide be for?

While FDA approval of Lilly’s other weight loss drug, tirzepatide, is expected in the coming months, Skovronksy said he believes that it can coexist with retatrutide.

“We don’t stop with one medicine for Alzheimer’s disease,” he said. “The same will be true for metabolic disease, including obesity and Type 2 diabetes. We’ll need different kinds of medicines for different patients.”

Jastreboff agreed. Retatrutide could be an option for people who don’t respond well to other weight loss medications. Given its potency, it could also be useful for people who need to lose a substantial amount of weight, she said.

Still, retatrutide has a long way to go before it’s available to the public.

“It is early days,” Skovronsky said. The company has started enrolling participants in a larger phase 3 clinical trial, which will include thousands of participants. The trial is expected to be completed in December 2025, according to clinicaltrials.gov. After that, if the results hold up, the drug would need to go through the FDA’s rigorous review process.

Skovronsky said he hopes that retatrutide could one day provide the same levels of weight loss seen with bariatric surgery.

He also said that retatrutide and drugs like it could potentially be used to treat obstructive sleep apnea as well as decrease the risk of heart disease.

“This is really a golden age of drug discovery for treatments,” he said.

Leqembi, Alzheimer's Disease

Please listen to the NPR report which is a powerful and accurate summary of the new Drug

The Food and Drug Administration has fully approved Leqembi, the first drug shown to slow down Alzheimer's disease.

By Jon Hamilton

The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer's disease.

The action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who are in the early stages of the disease will have access to the drug – and be able to afford it.

"It's not something that's going to stop the disease or reverse it," says Dr . Sanjeev Vaishnavi, director of clinical research at the Penn Memory Center. "But it may slow down progression of the disease and may give people more meaningful time with their families."

In studies reviewed by the FDA, Leqembi appeared to slow declines in memory and thinking by about 27% after 18 months of treatment. It also dramatically reduced the sticky beta-amyloid plaques that tend to build up in the brains of people with Alzheimer's.

"It's very exciting that we're targeting the actual pathology of the disease," Vaishnavi says.

Just to be talking about a treatment "is an incredible point for the Alzheimer's cause overall," says Joanne Pike, president and CEO of the Alzheimer's Association.

Leqembi comes from the Japanese pharmaceutical company Eisai and its U.S. partner Biogen. The companies have said Leqembi will cost about $26,500 a year.

In January, the drug received what's known as accelerated approval from the FDA, based on its ability to remove the substance beta-amyloid from the brains of people in the early stages of Alzheimer's. Full or traditional approval reflects the FDA's assessment that Leqembi also helps preserve memory and thinking.

Also in January, the Centers for Medicare and Medicaid Services announced it would broaden coverage of Leqembi on the same day the drug received full FDA approval. That should mean the drug will now be covered for most Medicare patients with early signs of cognitive problems and elevated levels of amyloid.

Wider coverage, limited use

Until now, Medicare has paid for Leqembi only for patients in certain clinical trials.

Under the expanded coverage, a million or more Medicare patients are potential candidates for the drug. But it's likely that a much smaller number will actually get it in the next year

One reason is the drug's potentially life-threatening side effects, Vaishnavi says.

"I think [patients] are a little wary because they hear about bleeding or swelling in the brain," Vaishnavi says. "They are concerned, and I think rightfully so."

Another limiting factor is that the U.S. healthcare system simply isn't prepared to diagnose, treat, and monitor a large number of Alzheimer's patients, Pike says.

Leqembi requires an initial test to determine amyloid levels in the brain, intravenous infusions every other week, and periodic brain scans to detect side effects.

FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval

Action Follows Confirmatory Trial to Verify Clinical Benefit

For Immediate Release: July 06, 2023

Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease.

Leqembi was approved in January under the Accelerated Approval pathway. This pathway allows the FDA to approve drugs for serious conditions where there is an unmet medical need, based on clinical data demonstrating the drug’s effect on a surrogate endpoint—in the case of Leqembi, reducing amyloid plaques in the brain—that is reasonably likely to predict a clinical benefit to patients. As a postmarketing requirement of the accelerated approval, the FDA required the applicant to conduct a clinical trial, often referred to as a confirmatory study, to verify the anticipated clinical benefit of Leqembi. Efficacy of Leqembi was evaluated using the results of Study 301 (CLARITY AD), a Phase 3 randomized, controlled clinical trial.

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans. The disease slowly destroys memory and thinking skills and eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer’s are not fully known, it is characterized by changes in the brain—including the formation of amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections. 

Study 301 was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that enrolled 1,795 patients with Alzheimer’s disease. Treatment was initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology. Patients were randomized in a 1:1 ratio to receive placebo or Leqembi at a dose of 10 milligrams (mg)/kilograms (kg), once every two weeks. Leqembi demonstrated a statistically significant and clinically meaningful reduction of decline from baseline to 18 months on the primary endpoint, the Clinical Dementia Rating Scale Sum of Boxes score, compared to placebo. Statistically significant differences between treatment groups were also demonstrated on all secondary endpoints, which included the Alzheimer’s Disease Assessment Scale Cognitive Subscale 14, and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment. 

On June 9, the FDA convened the Peripheral and Central Nervous System Drugs Advisory Committee to discuss whether Study 301 provided evidence of clinical benefit of Leqembi for the treatment of Alzheimer’s disease. All committee members voted affirmatively that the results of the study verified the clinical benefit of Leqembi for the indicated use.

The most common side effects of Leqembi were headache, infusion-related reactions and amyloid-related imaging abnormalities (ARIA), a side effect known to occur with the class of antibodies targeting amyloid.  ARIA most commonly presents as temporary swelling in areas of the brain seen on imaging studies that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain. Although ARIA is often not associated with any symptoms, symptoms can occur and include headache, confusion, dizziness, vision changes and nausea. ARIA can also infrequently present with serious and life-threatening brain edema that can be associated with seizures and other severe neurological symptoms. Intracerebral hemorrhages can occur in patients treated with this class of medications and can be fatal. A boxed warning is included in the prescribing information to alert patients and caregivers to the potential risks associated with ARIA. 

Patients treated with Leqembi who are homozygous for the ApoE ε4 allele have a higher incidence of ARIA, including symptomatic, serious and severe ARIA, compared to heterozygotes and noncarriers. The prescribing information states that testing for ApoE ε4 status should be performed before starting treatment with Leqembi to inform the risk of developing ARIA. 

Use of anticoagulant medication was associated with an increased number of intracerebral hemorrhages in patients taking Leqembi compared to placebo. The prescribing information recommends caution when considering use of Leqembi in patients taking anticoagulants or with other risk factors for intracerebral hemorrhage. 

Leqembi is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of its inactive ingredients. Adverse reactions may include angioedema (swelling) and anaphylaxis (allergic reaction). 

Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease, the population in which treatment was studied in clinical trials. The labeling states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

The approval of Leqembi was granted to Eisai Inc.

FDA grants full approval to new Alzheimer's drug meant to slow the disease.

The first approved drug to slow the progression of the illness will come with a strong safety warning about potentially life-threatening side effects.

By Berkeley Lovelace Jr.

The Food and Drug Administration on Thursday fully approved the Alzheimer’s drug Leqembi, amid concerns about its safety, cost and accessibility.

The move marks the first time that a drug meant to slow the progression of the disease has been granted full regulatory approval. Other approved drugs only target its symptoms.

"I don't think we can understate the significance of this moment," said Donna Wilcock, the assistant dean of biomedicine at the University of Kentucky.

About 6.7 million adults ages 65 and older in the United States have Alzheimer’s disease, according to the Alzheimer’s Association.

Leqembi, from Japanese drugmaker Eisai and U.S.-based drugmaker Biogen, targets a type of protein in the brain called beta-amyloid, long thought by scientists to be one of the underlying causes of Alzheimer’s disease.

In a phase 3 clinical trial of 1,795 patients with mild cognitive impairment or early-stage disease, progression of the illness was slowed by 27% over an 18-month period.

"While patients still do decline on the drug, the decline is slowed," Wilcock said.

Dr. Ronald Petersen, a neurologist at the Mayo Clinic in Rochester, Minnesota, said in an email that Leqembi is not a cure, nor does it stop the disease.

"It’s a first step for hopefully more therapeutics in the future," he said.

The Alzheimer's Association, which has vocally advocated for the drug's approval, praised the decision.

The treatment could "give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love," Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.

"This gives people more months of recognizing their spouse, children and grandchildren," Pike said.

How does Leqembi help Alzheimer's patients?

In the phase 3 clinical trial, researchers measured cognitive decline using a scale that focused on how well patients performed in six categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.

For each category, patients were rated on a 5-point scale: 0 is normal, 0.5 is questionable dementia and 1, 2 and 3 are mild, moderate and severe stages of dementia, respectively.

Patients in the placebo group scored, on average, 1.66 on the scale after 18 months. Those who got Leqembi scored, on average, 1.21, a 0.45 difference or 27% slower rate of decline.

"In real-world terms, this likely means more time for the patient to be living independently, enjoying their hobbies, their friends and having a better quality of life," Wilcock said. "Time will tell how much, but the clinical trial did show significant benefit on activities of daily living measures."

Petersen said the drug appeared to slow a patient's decline for about five months.

Others, however, were less rosy about Leqembi's benefits.

Dr. Alberto Espay, a neurologist at the University of Cincinnati College of Medicine, said that the 27% slowing in the progression of the illness falls below the threshold of what would be "noticeable" to a patient.

“The odds for brain swelling and hemorrhage are far higher than any actual improvement,” said Espay, who launched a petition in June calling for the Alzheimer’s treatment to not get full approval.

In its approval, the FDA included its strongest warning label — called a boxed warning — about these particular side effects, noting that they can lead to seizures and death. In addition, before starting the drug, patients should undergo genetic testing to better understand their risk for these side effects.

About 12.6 % of patients who got Leqembi in the trial developed brain swelling, compared with 1.7% of those in the placebo group. About 17% of the Leqembi group experienced brain bleeds, compared with 9% in the placebo group. The side effect is also seen with another Alzheimer’s drug, Biogen’s Aduhelm, which also works by targeting amyloid in the brain.

Thee deaths were also linked to the drug in the clinical trials.

Petersen said that in about 75% of people, the brain side effects, which were detected on MRI scans, did not cause symptoms.

Who will be able to get Leqembi?

Leqembi was approved for people with mild cognitive impairment or early-stage Alzheimer's disease. The drug is given intravenously every two weeks, meaning patients will need to go to a hospital or clinic for the infusion.

In addition, a roundtable of Alzheimer's experts recommends patients get periodic brain scans to monitor for any side effects.

Leqembi will carry a list price of $26,500 a year.

In June, the Centers for Medicare & Medicaid Services said it planned to provide coverage for Leqembi and other drugs in its class, contingent upon receiving full FDA approval. However, the agency said it will mandate that physicians gather real-world performance data on these medications through a government database. That means that only doctors who are willing to collect this data will be able to prescribe Leqembi.

Following Thursday's approval, the CMS said in a release that the registry was open for physicians to access. The agency also listed steps patients should take to ensure they get Medicare coverage.

Medicare will cover 80% of the cost of the drug after patients meet their deductible, meaning patients will be responsible for paying the remaining 20% out-of-pocket, amounting to several thousand dollars.

Tomas Philipson, an economist who served as a senior economic adviser to both the FDA and the CMS under former President George W. Bush, said that the rule means some patients will still not be able to afford Leqembi.

"It will limit somewhat, but it will not limit as much as what the CMS is doing to the entire class currently," Philipson said, referring to restrictions the agency placed on drugs that had been granted a fast-tracked version of approval, also known as accelerated approval. In order to receive coverage for accelerated approval drugs, patients must be enrolled in a clinical trial.

Leqembi was initially granted accelerated approval in January, before the FDA had time to review phase 3 clinical trial results.

In June, an independent advisory committee to the FDA voted unanimously that data from the trial showed Leqembi provided a benefit to Alzheimer’s patients, recommending the agency should grant it full approval.

Leqembi’s approval is significant for patients and the health care system, said Philipson, now a professor at the Harris School of Public Policy at the University of Chicago. He co-authored a paper in June that found delaying coverage of Leqembi and other drugs in its class could cost the U.S. more than $500 billion.

Leqembi’s full approval leapfrogged that of Biogen's Aduhelm, which was granted accelerated approval in 2021.

That approval came despite an FDA advisory committee’s finding that the drug was unlikely to work. Later, an 18-month congressional investigation found that the FDA failed to adhere to its own standards and that its approval of Aduhelm was “rife with irregularities,” putting the agency under further scrutiny.

Aduhelm initially cost $56,000 a year, threatening to raise Medicare premiums, before the company decided to cut that total in half. With only accelerated approval, the drug is only covered by Medicare if people are enrolled in a clinical trial.

No date has been set on when the FDA could make a decision on Aduhelm’s full approval.

Harvard Health Ad Watch: How direct-to-consumer ads hook us

If you’re like most people, you’ve seen a ton of direct-to-consumer (DTC) drug ads in recent years. They’re all over television, in magazines, online, on billboards, and slapped on the sides of buses, promoting treatments for arthritis, cancer, heartburn, psoriasis, flagging memory — and more. The deluge of drug ads can be overwhelming. Worse, the information is often incomplete, biased, or confusing.

We launched the Harvard Health Ad Watch series to highlight some benefits and problems with health product advertisements. We’ll focus on the evidence behind the ads and show you how — and why — to view them with a skeptical eye.

This post briefly explains direct-to-consumer advertising and FDA regulation, as well as the rationales and potential drawbacks of these ads. It also alerts you to words to consider very carefully when advertisers clamor for your attention. In other posts, I’ll analyze some popular health product ads.

How common are DTC ads for health products?

Almost every country in the world bans DTC ads for health products like medications and procedures. Years ago in the US, drug ads were directed primarily at doctors. But in 1997 the FDA eased restrictions to allow pharmaceutical companies to advertise directly to consumers. With restraints lifted, spending on prescription drug ads soared to nearly $10 billion a year, and is rising.

Do the ads work well for drug companies? Yes, indeed! If these ads didn’t work, drug companies would never spend so much on them. Do they actually improve patient health? That’s far less clear.

The FDA has a limited role in DTC advertising

FDA regulations require that advertising be accurate, and promote only approved drugs for approved conditions (called indications). Additionally, ads must state medication risks and ways to get more information. The FDA’s goal is to assure prescription drug information is "truthful, balanced, and accurately communicated" — a lofty aim that receives mixed reviews.

The rationale for DTC ads

Advocates often present the ads as a chance to

• educate people about conditions and treatments they were unaware of
• improve health by encouraging people to take medications they should be taking
• raise awareness of possible side effects, because regulations require consumers to be referred to a website, magazine, or other source for more information
• lessen stigma surrounding certain conditions, such as mental illness or erectile dysfunction
• increase detection of unrelated diseases if patients are inspired by DTC ads to see their doctors.

Potential drawbacks to DTC ads

Unfortunately, experience shows that some DTC ads may

• present incomplete or biased information
• spur people to ask for medications they don’t need
• promote medications before long-term safety is known. In one case, a new pain relief drug was pulled from the market due to an unexpected rise in heart attacks and strokes — but not before millions of people saw the ad and began taking it.
• create conflicts between patients asking for a drug and doctors who don’t recommend it
• drive up healthcare costs without adding health benefits (new drugs are much more expensive than generic drugs that may do the same job, yet cost is rarely mentioned in the ads).

Advertising words to consider very carefully

Keep this in mind: the main purpose of DTC drug advertising is to sell a product, not educate consumers. The language of drug ads makes that clear. Consider these common examples.

• "A leading treatment for this condition." Perhaps, but what if there are only two or three drugs available for that condition? When considering any treatment, it’s important to know what the other options are and how they compare, yet it’s unlikely this additional information will be mentioned.
• "No other treatment has been proven better." This suggests that the advertised drug is great. Yet it might be only as good as — and no better than — older, less expensive, or even over-the-counter competitors. Plus, drug ads are unlikely to mention the option of taking nothing for the condition in question, even though many minor ailments get better on their own.
• "In clinical studies, this medication proved more effective than standard treatment." So, how good is standard treatment? If a drug helps only 20% of people with a disease and "standard treatment" helps 15%, the added cost and risk of side effects of the new therapy may not prove worthwhile.
• "I don’t care about studies… it works for me" or "This drug gave me my life back." The power of the anecdote — one person’s story of near-miraculous improvement with a particular treatment — is undeniable. The problem is that studies do matter. Otherwise, we’d all be taking the advice of a proverbial "snake oil salesman" recommending unproven and potentially dangerous drugs because someone said it worked for them. And, of course, in ads promoting drugs or procedures, that "someone" is often a paid actor or spokesperson.
• "For some, one pill is all you need for 24-hour relief." This sounds good, but how many is "some"? If one in 100 get 24-hour relief, the drug may be less effective than the ad suggests. Also, what does "relief" mean? If a drug reduces pain by 10% for 24 hours, that’s a rather modest benefit; a competitor’s drug might reduce it by 80% or even 100%. These details are often left out of drug ads.

The bottom line

As an arthritis specialist, I’ve found that patients who ask me about drug ads are often surprised to hear about important information the ads left out. For example, most of the newest and most effective drugs for rheumatoid arthritis are given by injection under the skin or into a vein, yet many ads for these drugs never mention this!

Also, I think DTC drug advertising has had unexpected costs: these ads tend to "medicalize" everyday aches, pains, and other symptoms while calling for prompt treatment with their medication. For some people, this constant barrage may be terrifying or anxiety-inducing, as if just around the corner there lurks a new deadly or debilitating condition you should hurry to investigate with your doctor.

So, be wary. Even if information in a drug ad can be considered accurate, it may not be thorough, balanced, or unbiased. In the end, it’s another instance of buyer beware. Stay tuned.