Bias in Sponsored Clinical Trials

 

How reliable are the results of clinical trials of new drugs? That’s an important question and one that is getting the attention of researchers.

When a pharmaceutical company develops a new drug, they must first put it through a clinical trial to prove its efficacy and safety. That means patients volunteer to be “guinea pigs” to find out if a new medicine will help them. Only after extensive clinical trials can a new drug be accurately evaluated. Clinical trials are required for FDA approval and form the basis of all new pharmaceutical developments.

But how reliable are these clinical trials and do they have an inherent bias? Huey Freeman, writing for The Epoch Times, tells us of some recent research that suggests there may be bias in some of these trials. He says, “Drug studies sponsored by drug manufacturers tend to report higher drug efficacy than studies not sponsored by drug companies, a report published in the Journal of Political Economy on Oct. 7 found. The report found a “sponsorship effect” that tends to bias sponsored studies toward reporting higher drug efficacies. The author could not find differences in study design between those funded by drug companies and those not.

“Removing the sponsorship effect would reduce the difference in efficacy … by about 50 [percent],” Tamar Oostrom, an assistant professor of economics at Ohio State University, said in her paper.”

“This effect was larger than I expected,” Oostrom told The Epoch Times over email. “My results suggest that sponsored arms of trials should be discounted substantially.” She said that the difference in results between sponsored and unsponsored trials may be that “manufacturers are running multiple trials and selectively publishing those that are more favorable towards their drug.”

Her research analyzed the published papers of 509 trials and 1,215 treatment arms (groups of participants). Most of the trials were published after the drug gained approval from the U.S. Food and Drug Administration. About three-quarters of those examined were for antidepressants, with the remaining quarter for antipsychotic medications. “My paper is the first to examine the effect of financial sponsorship on outcomes by directly comparing a large set of trials in which the exact same arms are tested with differing financial interests,” Oostrom wrote.

There is an obvious incentive for pharmaceutical companies to try to influence the results of clinical trials. Trials in which the manufacturer’s drug does well are more likely to be published. Publications are then used to market the drug to physicians who in turn are more likely to prescribe the new drug.

As an example of bias, Oostrom presented the case of Effexor, an antidepressant introduced by Wyeth Pharmaceuticals in 1993. Over the following 15 years, Wyeth funded 14 randomized controlled trials comparing Effexor’s effectiveness with that of its rival, Prozac. In 12 of these trials, funded solely by Wyeth, Effexor was found to be more effective.

However, when Effexor and Prozac were compared with alternative funding, only one out of three trials found Effexor to be more effective. “Each of these trials is a double-blind RCT comparing the exact same two molecules and examining the same standard outcomes,” Oostrom wrote in her paper.

This research only looked at psychiatric drugs but the results and conclusions may well apply to other clinical trials, too. More research is needed to see if this same bias is present in other clinical trials.

Understanding Cell Phone Addiction – Part III

 

In Part I of this series, we learned that many people suffer from cell phone addiction or digital dependency. This addiction is enhanced by a neurotransmitter in the brain, dopamine, that reinforces this behavior by giving people temporary pleasurable feelings, much like gambling or heroin addiction.

In Part II we learned there are many different categories of this addiction including Social Media, Gaming, Information, Texting and Messaging, and Gambling. These can lead to adverse impacts on our lives such as Mental Health Disorders, Social Isolation, Relationship Strains, Productivity Decline, Sleep Disruption, and Fear of Missing Out.

Today we will discuss ways to fight back and overcome this addiction. Dr. Gregory Jantz, mental health specialist, tells us to use these strategies:

Set Time Limits

Many smartphones now offer built-in-screen time tracking features that allow users to monitor their usage and set time limits for specific apps. Set daily limits for social media, games, or entertainment apps, and adhere to them.

Create Phone-Free Zones

Designate certain areas, such as the dinner table, or times, such as during meetings or before bed, as “phone-free.” These boundaries can help reduce screen time and encourage more meaningful engagement with those around you. 

Turn Off Notification

One of the most effective ways to reduce phone usage is to turn off nonessential notifications. Constant pings and vibrations trigger compulsive behavior, making it hard to resist checking the phone.

Engage in Physical Activities

Replace mindless scrolling with activities that improve your physical and mental well-being. Exercise, sports, or outdoor hobbies can provide a break from screens while promoting a healthier lifestyle.

Schedule Times for a “Digital Detox”

Be intentional about taking periodic breaks from your phone. This could mean going a few hours each day without it or dedicating an entire day of the week to disconnecting from screens. Or schedule a weekend retreat, where you engage in real-world activities without technology.

Prioritize Face-to-Face Interactions

Make a conscious effort to engage more in person. Whether it’s scheduling time with family and friends or attending social events, these real-world interactions provide emotional fulfillment and help reduce reliance on virtual connections.

Reframe Your Mindset

Shift how you think about your phone. Instead of seeing it as a source of entertainment or constant connection, view it as a tool meant for specific purposes, such as communication and work. Reframing your relationship with your device can help reduce its appeal as a mindless escape.

I hope you have enjoyed this deep-dive into the science and reality of cell phone addiction or digital dependency. While most common in young people, it is becoming increasingly more prevalent in the adult population. As in all addictions, recognizing the problem is the first step toward overcoming the problem.

Understanding Cell Phone Addiction – Part II

 

In Part I of this series, we discussed cell phone addiction; a growing problem in our digital world. There is evidence this problem is widespread and based on similar neuroscience to other addictive behaviors like gambling or shopping.

Dr. Gregory Jantz, a mental health specialist who treats additive disorders in Edmonds, Washington, tell us there are many types of phone addiction. Here are some of the different categories of addiction based on how the phone is used he has been able to identify:

Social Media

This form of addiction revolves around compulsive use of platforms like Facebook, Instagram, Tik Tok, and X. Users spend hours browsing feeds, posting content, and seeking validation through likes, comments, and followers. Individuals with this addiction are seeking the approval of their peers.

Gaming

Mobile gaming has surged in popularity, and some users find themselves hooked on games designed to offer endless levels or challenges. Games like Candy Crush, Clash of Clans, and Call of Duty are notorious for fostering compulsive gaming behavior.

Information

Some people are addicted to consuming endless streams of information. They feel a need to constantly stay updated with the latest news, trends, or knowledge, often spending hours browsing news sites, Reddit, or Quora.

Texting and Messaging

The compulsion to constantly check messages, respond immediately to texts, or engage in endless conversations through messaging apps like WhatsApp or Snapchat is another form of addiction. The need for instant communication and fear of missing out on conversations fuel this behavior.

Gambling

With mobile apps for casinos, sports betting, and online poker just a tap away, users can gamble without having to travel or even log on to a desktop computer. Gambling apps employ psychological techniques similar to those used in mobile games to keep users engaged. Through variable reward and payout algorithms, players experience intermittent wins that rigger dopamine release and reinforce the urge to continue gambling.

How can phone addiction or digital dependency affect your life?

Mental and Emotional Health

Dr. Jantz tells us numerous studies published in scientific journals have demonstrated the link between digital device addiction and mental health issues, including severe depression, anxiety, and even suicidal ideation. One study has even described this as “heroin for millennials.”

Social Isolation

Many individuals find themselves preferring virtual interactions over face-to-face communication, leading to a breakdown in real-world social skills and increased feelings of loneliness. The illusion of being connected through texting and social media often replaces meaningful, in-person connections, leaving individuals feeling more isolated despite being constantly online.

Relationship Strain

When one partner is glued to the phone during conversations or shared activities, it can lead to feelings of neglect and disconnection. This can cause tension and contribute to the breakdown of relationships, especially if phone use becomes a substitute for real interaction.

Productivity Decline

Constant notifications, combined with the urge to check for updates, makes it difficult to accomplish tasks. Research shows that multi-tasking can reduce efficiency and increase cognitive load, leading to decreased performance.

Sleep Disruption

Many people check their phones right before bed or wake up in the middle of the night to browse social media or answer texts. This habit interferes with sleep quality, leading to fatigue and diminished cognitive function.

Fear of Missing Out

People with this form of addiction are constantly checking for updates or messages to avoid missing something important or interesting. Additionally, seeing the “highlight reels” of others on social media contributes to feelings of inadequacy and loneliness.

(Note: For information on how to overcome phone addiction or digital dependency, read my next blog.)