Category: Research Findings

What’s the Deal with Male Birth Control?

By: Aria Gray MPH: Maternal and Child Health candidate 2017

I have been on many different types of birth control in the past 10+ years, all with varying levels of success and each with a new set of side effects including migraines. It has never been a question of if I should try a new method since no there is no effective reversible male birth control available.

Recently, it has made headlines that a male birth control shot has been found to effectively prevent pregnancy in a newly published study. Unfortunately, participants in the study reported adverse side effects including mood changes, depression, and increased and 20 participants dropped out of the study leading researchers to stop the study earlier than planned.

These reports come very soon after another recently published study that was in the news, which cited that hormonal birth control can cause depression in women.

While this particular study was cut short, it is my hope that research continues to search for a safe and effective method of male birth control. Over 80% of the male participants in the study responded that they would use this method of contraception outside of the study, which is hopeful for the future, and a sign that this method is very much wanted and needed. Both women and men deserve to have reproductive freedom without having to jeopardize their health or mental health.

But for now, until male birth control that is safe and effective is developed and approved, women must bear an unequal burden to prevent unwanted pregnancies.

Read more about this interesting topic here.

Research Dissemination: Part 2

The most highly regarded place to publish medical research findings is in a peer-reviewed scholarly journal. However, journals are not all considered equal.

Most people have at least heard of the so-called “top-tier” journals including The Journal of the American Medical Association (JAMA), the British Medical Journal, and the New England Journal of Medicine. There are also mid-tier journals which are still respectable, but less competitive, and then there are lower quality journals whose standards and peer review process are much less rigorous (or non-existent) and consequently are taken much less seriously by the medical community.  

The dream is usually to have an article published in a top-tier journal, however, this is not always the best choice depending on the content and goal of a paper. If a paper does not present novel and/or ground-breaking findings, it is probably not worth an author’s’ time to submit it to a top journal and then wait, only to be rejected. Also, if authors’ want to get the results of a study published quickly so that the data is publicly available (for instance to help support an application for FDA approval), it is probably better to go with a less prestigious journal that has a higher acceptance rate or a less rigorous review process.

In addition to journal prestige, there are many other factors that must also be considered when deciding where to submit a manuscript. For example, medical specialty, target audience, impact factor, primary language or region, length limits, and allowance of figures and other supplementary materials are all potential considerations.

Due to the complexity of the factors that weigh into this decision, many medical publications agencies offer assistance with target journal selection by researching and compiling this information for authors so that they can more easily make a decision based on the variables that are most important to them for a particular manuscript.

Getting the right information in front of the right audience in a timely manner is critically important in fields such as medicine and pharmaceuticals since that information could potentially affect the lives and well-being of countless individuals.

Publication Planning: You have the data, now what?

Research, in any field, tends to be time-consuming and expensive. This is especially true of large-scale medical research trials. Therefore physicians and pharmaceutical companies, just like researchers in other fields, want to make optimal use of their research activities by producing as many publications from the resulting data as possible.

There are limits to how far these boundaries can be pushed, however. For example, duplicate publications are generally not permissible. This “double-dipping” includes publishing or presenting an identical work in multiple journals or at multiple conferences, but it also bars researchers from reworking a published piece in a way that does not contribute any new knowledge or insights to the results that were originally published.

One study usually measures a large number of variables and can therefore still be broken down into countless publications without violating sanctions against duplicate publications. For a clinical trial of a particular drug, for example, publications could focus on different outcome measures, such as the mechanism of action, safety, efficacy, economic considerations, administration, adherence, etc. Different publications could also examine these variable in various subgroups, such as pregnant women, the elderly, patients with certain co-morbidities, etc.   

In order to balance the desire for publication volume with the need to be ethically responsible by only publishing works that have scientific value, it is essential that large organizations and companies engage in publication planning activities. By convening a group of stakeholders at a publication planning meeting, an organization or company can lay out all of their available study data and determine what can and should be published from it.

In addition, gap analyses can be conducted to determine the topics or types of information that are missing in the current body of literature which can then serve as basis for future research studies intended to produce that information.

In this way, the cycle of medical research and publishing is continually pushed forward to produce new and valuable knowledge, both for the research community and for healthcare providers.

Is industry sponsorship a problem? Considerations for ethical research and medical publishing.

Clinical research and other drug development and testing activities can be funded, or “sponsored,” by a number of sources, including physicians, universities, government agencies, special interest groups, and pharmaceutical companies. Many people have an understandable concern regarding the reliability of research funded by the pharmaceutical companies that stand to make a profit from the drugs being tested.

While these conflicts of interest will probably always be a concern, it is important to note that there are increasingly more regulations and safeguards being put into place both within the industry and from external sources like the federal government in order to encourage the use of ethical practices in medical research and publishing.

I was also skeptical of the legitimacy and/or motives behind industry-sponsored research, however, what I didn’t realize until I began working within the medical publishing industry was the extent to which research and marketing activities are deliberately segregated by pharmaceutical companies.

For example, the parent company at which I’m currently interning encompasses both a medical publishing agency and a health care marketing agency. Although everyone works in the same building, the agency’s pharmaceutical clients generally require that any of the agency’s staff members who are involved with marketing or advertising for their company not be involved with the planning or publishing of the clinical research being conducted for their products.

So, contrary to what some may perceive to be true, it is not the case that marketing teams are soliciting particular studies or data to be collected in order to help them sell a product. Instead, physicians and researchers are designing and conducting studies based on the scientific and clinical value of the data being produced. In this way, the scientific information is originating from scientists and medical professionals and then being provided to marketing and advertising departments, and not the other way around.

Come back next week for part two of this discussion on the ethical considerations involved in medical publishing.

Smoking Rates Down, E-Cigarette Rates Up

Earlier last month, the FDA announced a new rule that would extend the authority given to them in the 2009 Family Smoking Prevention and Tobacco Control Act to include all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco.

If you’re not familiar with the original act, you may be wondering, what does this mean? 

Well, prior to this new rule taking place, there were no federal regulations on e-cigarettes, which meant e-cigarette companies had the ability to sell to minors under the age of 18 without restriction. Given the rising rate of e-cigarettes over the last few years, especially among youth, this lack of regulation caused reason for public health concern.

The CDC’s most recent Youth Risk Youth Behavior Survey revealed that among high schoolers, while cigarette use decreased significantly from 28 percent in 1991 to 11 percent in 2015, 24 percent of students reported using e-cigarettes during the past 30 days. Even though cigarette use is at an all time low for this population, many health experts fear that e-cigarettes may serve as a gateway to smoking. More importantly, most e-cigarettes contain nicotine, which has been shown to have a negative impact on adolescent brain development.

The new rule is a foundational step for the FDA in protecting people from the dangers of tobacco use. Not only does it allow the FDA to restrict sale of e-cigarettes to minors, but also allows them to regulate the marketing and distribution of these products. This means the FDA will help to prevent misleading claims made by manufacturers, evaluate ingredients, and communicate risks of these new tobacco products.


Inside Medical Publishing: What information is being published?

Last week we discussed the basics of what medical publishing is and why it’s important. Today I want to look at the actual substance of what’s being published. There are many different types of information that are published or presented in the medical community, including original research, meta-analyses, systematic reviews, case studies, review articles, editorials, and more. Of these types of medical publications, the most familiar and most common is the reporting of the methods and results of clinical studies, both observational studies and controlled clinical trials.

The purpose of these studies can vary but generally they fall into one of the following categories; assessing the safety or efficacy of a drug, device, procedure, or lifestyle; investigating or testing methods for identifying and diagnosing conditions; comparing interventions or care models; determining risk factors and effects of conditions; or determining methods for improving quality of life.

Clinical trials of drugs in particular consist of a major, multi-step research process that is highly regulated. These trials fall into one of 5 phases (from 0-4) which range from isolating and testing potentially useful compounds, to continued long-term studies of a drug’s safety and efficacy after it hits the market. To read more about these clinical trial phases, check out the FDA’s more detailed description here.

Also, if you’re interested in the kinds of clinical research being conducted or you’d like to be involved as a research participant, you can check out the U.S. clinical trials registry where researchers post information about their studies, recruit study participants, and even sometimes post their results for the public to see.

What is medical publishing?

This summer I’m interning at a scientific communications agency that focuses on providing medical publication support to pharmaceutical and medical device companies. This summer, I’ll be writing a series of blog posts that explore the process of medical research and publishing. So, first things first…

What is medical publishing?

Medical publishing is the process by which the information and data produced through medical research is distributed in an effective, ethical, and transparent way so that health care providers can ultimately use that information to provide the best possible treatment and care to their patients.

Researchers both nationally and internationally are continually producing new medical knowledge by developing and testing drugs, devices, procedures, treatments, and diagnostics. The data that are collected during these studies have the potential to drastically impact the way that physicians and other health care providers diagnose and treat their patients.

However, in order for health care providers to adopt the most effective practices, they first need access to the information that indicates which products and practices are the safest and most effective for a particular condition or patient.

This is where medical publishing steps in to fill the gap between research and practice. By publishing the results of medical studies in a credible and trustworthy way, this vetted information can then be accessed by practitioners who turn to these publications for the most up-to-date, high-quality information when treating patients.

In addition, by publishing the results of these studies, both the research community and industry can also stay connected to what’s going on in their respective fields, which is critical for maintaining a productive and informed cycle of research and development.    

The Brain Controls the Body, But Can the Body Control the Brain?

We all know our moods can affect how active we are, but did you know how much you move can also have an affect on our mood?

That’s right, according to researchers at Harvard Medical School, the connection between your brain and your body is a two-way street. They found that consistent exercise, such as running, cycling, and aerobics can affect your mood by increasing a protein found in the brain called brain-derived neurotrophic factor, or simply BDNF, which aids in the growth of nerve fibers.

Other studies have shown that those with ADHD can reduce their symptoms (although only temporarily) by doing 20-minutes of exercises such as cycling. Afterward, participants were motivated to do tasks that required thought and were less depressed, tired, and confused.

Forms of meditation, such as yoga, qigong, and tai chi were all shown to be helpful at alleviating depression, by allowing people to pay closer attention to their bodies and not on external factors. These changes in posture, breathing, and rhythm have all shown to affect the brain in a positive way. In some cases, people with post-traumatic stress disorder (PTSD) no longer met the qualifications for it once they began practice meditative movement.

Additionally, another study has shown that while exercise is beneficial for well being, self-esteem if further improved when moving synchronously with someone else. Moving along with someone else also showed signs of cooperation and charity toward others, as well as improved memory and recall skills.

Ultimately, these findings only stress the close connection held between your brain and body, and show that how much you move can not only help you stay physically fit, but can also affect the way you think and feel. These findings also present an alternative remedy to more traditional treatments for depression, such as psychotherapy and medication.

So next time you find yourself exhausted and completely overwhelmed, put on your sneakers and take a few minutes to get some exercise. You’ll not only sleep better, but in time, you may find yourself feeling more positive about life as well.

Coffee: Foe or Friend?

Coffee has long been debated about whether or not it’s healthy, particularly since most of us drink it on a daily basis. While some reports have linked it to heart disease and cancer, recent developments are showing that coffee, indeed, is good for your health — or at least the benefits outweigh the risks.

So why the reversal? Well, one explanation, is that previous studies failed to consider that high risk behaviors, such as smoking, drinking, or physical inactivity were likely to be more common among coffee drinkers, and those factors could have resulted in the negative beliefs about coffee consumption.

Most studies are now finding an association between coffee consumption and decreased mortality, in particular, reduced cardiovascular mortality. Other studies have shown that coffee is linked with reducing the occurrences of Parkinson’s disease, type II diabetes, breast cancer, and liver disease, while increasing cognitive function and decreasing depression.

Doctors at the Harvard School of Nutrition say coffee works at minimizing depression not only for its caffeine content, but also by controlling inflammation in the brain through its high number of anti-inflammatory polyphenols, which are also found in fruits and vegetables. By reducing the amount of inflammation, the brain can then produce more serotonin, also known as the “feel good” chemical, which is found in antidepressant medications.

However, doctors say not all coffee is the same, and to look for brands with high amounts of polyphenols. Also, if you’re looking for a healthier way to drink coffee, the suggested daily recommendation is 1-2 cups, so anything over may end up being detrimental, especially if your body doesn’t metabolize it as quickly. Over consumption of coffee can also be linked to increased cholesterol levels and heart disease, so it’s important to drink it in moderation. It’s also suggested to consume more mild blends, as opposed to stronger brews like espresso. And finally, the less sweets you add to your cup o’ Joe, the better. Some sweetened coffee drinks can contain up to 500 calories!

Other Dangers of Using Devices at Nighttime

Most of us know that using mobile phones or e-readers before bed can disrupt our sleep cycles, but did you know there are other dangers associated with prolonged exposure to artificial light at night?

Recent research suggests that excess blue light exposure may be doing more than robbing you of a good night’s sleep, and could also increase your risk of cancer, obesity, and depression.

It’s important to understand why the blue light emitted from mobile devices affects your circadian rhythm. Typically, after awaking, people usually open the shades to let in the morning sunlight. Special cells in your eyes detect the natural light and signal your brain to shut off its production of melatonin. The physiological process doesn’t stop there—the morning light also signals cells to increase production of the stress hormone cortisol and a hunger-promoting hormone called ghrelin. The morning light also signals your body temperature and heart rate to rise.

In essence, the morning light allows your body to “reset” itself to prepare for the work ahead, which is exactly what’s supposed to happen in the early hours of the morning. However, this physiological resetting can sometimes occur at night, which is when things can start to go amiss.

Previous research has shown that people who use mobile phones, e-readers, or are exposed to LED lighting have increased appetite, took longer to fall asleep, experienced less restorative REM sleep, and were more tired the following day than those who did not use such devices before bedtime. Another study demonstrated where device users experienced a 55% drop in melatonin after only five days, which can be alarming because in addition to its sleep-inducing powers, melatonin has also been shown to be an anti-cancer agent.

While most of the recent research is too early to determine the true effect of blue light at night, scientists aren’t afraid to suggest that folks burning the midnight oil on their devices are more likely to be obese or suffer from heart disease. Other studies have linked late night workers to higher rates of both breast and prostate cancer.

So, in a world driven by technology, what can we do to ensure we’re getting the proper kind of sleep? Fortunately, there are several steps we can take that won’t require us to toss out our smartphones and computers. With a proper balance, we can have both!

The best advice public health gives us in this department is to power down those devices at a normal hour, or at least an hour before you go to bed (of course, the earlier the better).

Next, try reading an actual paper book before bed. Foregoing the artificial light from a phone or e-reader will signal your brain to begin producing melatonin at a decent hour to prepare your body for sleep.

Also, try purchasing energy-efficient light bulbs. Certain companies now produce bulbs that automatically change their hue depending on the time of day.

Finally, if you must use an electronic device before bed, purchase an app that allows your laptop or phone to emit blue light during the day and shifts to warmer wavelengths by evening. While this option isn’t as healthy as reading a traditional paper book, it should help your body to still produce some amounts of melatonin.

Sweet dreams!