Culture Affects Fitness

Exercise (no surprise) and culture (surprise!) were part of the focus at the Annual Meeting of the American College of Sports Medicine in Seattle at the end of May.

As part of the research presented, one study, conducted by Rafer Lutz, Ph.D., came to the conclusion that when under stress, college women who do not exercise regularly are less likely to exercise.

According to Lutz, “Someone who isn’t regularly active may view exercise as ‘one more burden’ when stressed.”

On the other hand, the study found college women with consistent exercise levels, “accumulate more physical activity” when similarly stressed. Lutz again expounds, “those who make it [exercise] a part of daily life may view it as a stress reliever and an escape from pressure.”

A second study presented at the Annual Meeting examined exercise differences between 400 American and Chinese college students. Researchers found that Americans exercise for weight control and physical appearance, whereas the Chinese students exercised for health and enjoyment reasons.

Lead study author, Zi Yah, M.S. concluded, “Although we didn’t study the origins of these exercise motivations, it may be a reflection of cultural values and what young people are taught to prioritize about themselves.”

Expanding this connection between exercise and culture further to include older women, another study is of note. In 2005, at the Second International Conference on Women, Heart Disease and Stroke, University of California San Francisco School of Nursing researchers proposed that exercise in tune with culture creates better program compliance.

They provided a Tai Chi program to older Chinese women with at least one major risk factor for coronary heart disease. Normally exercise programs for women with heart disease have high dropout rates but the retention rate for this one was 96% and there was a waiting list for the next session.

Part of the success of the study resulted from the researchers being culturally in tune with the group. One researcher, Ms. Taylor-Piliae had spent 15 years in Hong Kong, speaks Cantonese and is familiar with the culture. "Language was not a barrier to understanding in this study," she said. "This is important."

Researchers learned that Tai Chi appears to be a form of exercise that is safe and acceptable to Chinese women. "I think the key is to find out what already is a popular form of exercise within an ethnic group. If it is safe and is equivalent to brisk walking, then it not only may be effective, but more acceptable."

Risky Business

The FDA’s latest draft Industry Guidance paper addresses how drug companies should present risk information in ads for prescription drugs and medical devices. It is meant to illustrate factors the FDA considers when evaluating ads and labeling for drugs and devices for compliance to relevant regulations. It delves into the mind of the consumer and provides examples on how companies should present risk information.

Risk information is critical to both health professionals and consumers and needs to be clearly communicated to its target audience. According to the FDA, omission or minimization of risk information is the most common violation of regulations for product advertising and promotion. They also claim research in Direct to Consumer (DTC) prescription drug advertising has shown that:

• “60 percent of patients believe ads directed at them do not provide enough information about risks”
• “60 percent of physicians believe that patients have little or no understanding from these ads about what the possible risks and negative effects of the products are” and
• “72 percent of physicians believe that patients have little or no understanding from these ads about who should not use the product”

To comply with regulations ads cannot be false or misleading, they must reveal facts about the product and consequences from its use and they must present benefits and risks in a balanced manner. In other words, you can’t play up the drug’s benefits while downplaying its risks.

When evaluating a promotional piece, the FDA evaluates the net impression communicated by all the elements of the piece. It does so using “well-developed social science principles supported by decades of scientific research.” They use science to figure out how we understand best.

For example, the FDA explains how research indicates when people process a list of text they are better able to recall items at the beginning or end of the list. So ads should not insert important risk information in the middle of reams of text.

They also discuss how cognitive load, or the mental effort required to take in information, is affected by the amount of information presented and in what way. Word choice, loud colors and busy graphics can be distracting or put more emphasis on one piece of information versus another.

The bottom line from the guidance paper is that drug and device communications need to present risk and benefit information in a balanced manner and in language that is clear for its target audience.

A Wall Street Journal article reported that drug makers “remain committed to producing responsible, balanced promotional materials” and have adopted voluntary guidelines that say risks “should be presented in clear, understandable language without distraction.” via a PhRMA spokesperson.

Sales, Science and CME

Pharmaceutical sales reps are taking advantage of the same Continuing Medical Education (CME) programs usually offered exclusively to healthcare providers. By obtaining a broader understanding of the science that supports and differentiates their company’s products, sales reps hope to differentiate themselves from their competitors.

The idea seems to have merit. So far, one pharmaceutical company has determined that their sales reps should be accredited and has teamed up with the American Society of Hypertension (ASH). Beginning this summer, Daiichi Sankyo will be sending sales teams to a Hypertension Accreditation Program designed to improve their understanding of hypertension and related cardiovascular diseases.

“Physicians prefer to interact with well-informed pharmaceutical sales representatives who not only understand the company’s products, but have a keen appreciation for the disease and underlying science.” - Henry R. Black, MD, President of ASH

The idea of CME training for pharmaceutical sales reps is not a new idea, although in the past, the content of such training was largely centered on the regulatory and compliance issues that directed the interaction between sales representatives and healthcare providers.

While our global economy is experiencing a downturn, pharmaceutical company leaders are optimistic about the future. Part of that confidence, it seems, comes from the idea of a smaller, but scientifically savvy, sales force. Beginning with the recruitment of medically competent candidates, and then providing continuing medical education, the name of the game to stay ahead is differentiation.

In an industry experiencing tremendous shifts - from the path of product development to new avenues in marketing - competition for market share is intense. CME accreditation could be another way for a company to set itself apart from the field. But, with more knowledgeable sales teams leading to stronger communication with healthcare providers, the patient’s health is ultimately better for it.

by Audrey Miller

How Do You Know Your Translation Provider is Good?

¿Comprendes?

Please read the following information carefully as it pertains to the medication prescribed to your child:

Para recibir la cantidad correcta de medicamento es indispensable cebar el inhalador. Cébelo antes de usarlo por primera vez o cuando no lo haya usado durante más de 14 días. Para cebarlo, quítele la tapa a la boquilla del disparador. Después, agite bien el inhalador y haga una pulverización al aire, lejos de su rostro. Para terminar de cebarlo, haga otras dos agitaciones y pulverizaciones de esta forma.

So, if you only speak English, do you now know how to give your child his or her medication? How does this make you feel right now? Confused? Angry? Concerned? Imagine being a non-English speaker and this is how the piece of paper stapled to your prescription medication reads:

You must prime the inhaler to get the right amount of medicine. Prime the inhaler before you use it for the first time or if you have not used it for more than 14 days. To prime the inhaler, take the cap off the mouthpiece of the actuator. Then shake the inhaler well and spray it into the air away from your face. Shake and spray the inhaler like this 2 more times to finish priming it.

Filling a prescription may not help you if you are unable to understand when or how to take it. The leading cause of medication errors is patient misunderstanding of prescription drug label instructions.

A new study from Northwestern University surveyed pharmacies in Texas, Colorado, Georgia and North Carolina where there are large Latino populations. Of the 764 pharmacies, only 43.3% could offer instructions in Spanish. 21.7% offered some translation services and 34.9% offered no services.

Most pharmacies offer none or limited translation services and not just in rural areas or those with small Latino populations. The conclusion of the study was that “Spanish-speaking patients encounter barriers to acquiring instructions that support the safe and effective use of medications.”

Should knowing how to take your medication properly be limited to persons who only speak English? That seems rather discriminatory. In a country where we have so much, is being able to read your prescription medication instructions too much to ask?