FDA Ad Study: Clarifying the Confusion

As a public health agency, the FDA encourages the communication of accurate health messages about medical conditions and treatment.  One way the pharma industry does this is through non-branded disease awareness communications. These are aimed at either the general public or health care practitioners and discuss a particular disease or health condition, without making mention of any specific drug.  Usually, they encourage consumers to seek, and health care practitioners to provide, appropriate treatment for the particular disease state.

This is helpful for under-diagnosed and under-treated diseases such as depression, hyperlipidemia, hypertension, osteoporosis, and diabetes. Some research has shown that consumers prefer disease awareness advertising. It’s considered more informative and less persuasive than full product advertising.

The pharma industry likes it too.  Disease awareness communications are not subject to the regulations and restrictions mandated by the FDA for prescription drug advertising.

But now, the FDA is concerned that disease awareness ads might confuse consumers. According to a Federal Register notice issued on June 20, the agency wants to know whether the public can distinguish between product claims and disease information, and how different types of information impact comprehension.

So worried in fact,  the Agency has planned a study entitled, “Experimental Study: Disease Information in Branded Promotional Material” to look into those questions.

The study will examine print ads for three conditions – COPD, lymphoma and anemia.

4,650 American adults will be divided into three groups and asked to review the ads electronically.

  • One group will see information about the disease that avoids discussion of disease outcomes the drug has not been shown to address i.e.  “Diabetes is a disease in which blood sugar can vary uncontrollably, leading to uncomfortable episodes of high or low blood sugar.”
  • Other participants will see disease information that mentions consequences of the disease that go beyond the indication of the advertised product, such as, “Untreated diabetes can lead to blindness, amputation, and, in some cases, death.”
  • A third group will see drug product information only.

Disease information will be presented in different ways. For example, on alternating paragraphs, on separate pages or in different fonts and colors from product claims.

Specifically the study will address whether or not consumers are able to distinguish between claims made for a medication and general disease information when they see an advertisement for a drug.  For example, if an ad for a drug that lowers blood glucose, mentions diabetic retinopathy do consumers  think the drug will prevent the affliction, even if no direct claim is made?

The Agency says: “If consumers are able to distinguish between disease information and product claims in an ad, then they will not be misled by the inclusion of disease information in a branded ad. If consumers are unable to distinguish these two, however, then consumers may be misled into believing that a particular drug is effective against long-term consequences.”

SRxA’s Word on Health looks forward to seeing the results. Given that warning letters have been issued in the past over ads that contain mixed messages, this is an opportunity for the FDA to revisit its stance toward such advertising, reduce consumer confusion and, most importantly, learn how best to disseminate useful health information.

COPD – E

Word on Health was interested to note that regular use of vitamin E in women over 45 may help decrease the risk of chronic obstructive pulmonary disease (COPD), according to researchers at Cornell University and Brigham and Women’s Hospital. Long-term, the risk falls by approximately 10% in both smokers and non-smokers.

As lung disease develops, damage occurs to sensitive tissues through several proposed processes, including inflammation and damage from free radicals,” commented Anne Hermetet Agler, of  Cornell University’s Division of Nutritional Sciences. “Vitamin E may protect the lung against such damage.”

Previous research had found that higher intake of vitamin E was associated with a lower risk of COPD, but this is the first time it has been shown that increasing vitamin E intake can prevent COPD.

In this study, nearly 40,000 women aged 45 years and older were randomized to receive either 600 mg of vitamin E or a placebo every other day.  Although fewer women taking vitamin E developed COPD, the supplement appeared to have no effect on asthma.

If results of this study are borne out by further research, clinicians may recommend that women take vitamin E supplements to prevent COPD.

While this may be good news for some, Word on Health reminds its readers that vitamin E supplements are known to have detrimental effects in some people. For example it can cause increased risk of congestive heart failure in cardiovascular disease patients. As such, any future recommendations would need to balance both benefits and risks.

Do you have COPD, or tips for those who are living with the disease?  If so, SRxA’s Word on Health is waiting to hear from you.

Oral Corticosteroids as Effective as Intravenous Dosing in COPD

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States.  It affects more than 6 percent of adults in the US, and accounts for $32 billion in direct health care costs. Each year there are approximately 600,000 hospital admissions for acute exacerbation COPD, making this 1 of the 10 leading causes of hospitalization nationwide.

Systemic corticosteroids are known to be beneficial for patients hospitalized with acute exacerbation of COPD; however, their optimal dose and route of administration has, until now, been uncertain.

According to a new study published in JAMA , despite guidelines recommending use of the low-dose oral route, a higher-dose intravenous route was used in 92% of patients admitted to over 400 U.S. hospitals.

Researchers compared the outcomes of those initially treated with low doses of steroids administered orally to those initially administered high dose intravenous steroids during the first 2 hospital days.

The primary outcome analyzed was a composite measure of treatment failure, defined as the initiation of mechanical ventilation, in-patient mortality, or readmission for acute exacerbation of COPD within 30 days of discharge.

After results were adjusted for various factors including patient, hospital, and physician characteristics, the risk of treatment failure among patients given low doses of steroids orally was not significantly different from those treated with high-dose steroids intravenously. Also, pa­tients treated with low doses of steroids administered orally had shorter lengths of hospital stay and lower costs.

The authors concluded that the use of high dose intravenous steroids does not appear to be associated with any measurable clinical benefit and at the same time exposes patients to the risks and inconvenience of an intravenous line, potentially unnecessarily high doses of steroids, greater hospital costs, and longer lengths of stay.

An editorial in the same journal added that the results “are sufficient to take action to change practice now.”

Or as we frequently say here at Word on Health – less is sometimes more!

Breathing Easy

SRxA is pleased to report that it has been a week of good news for two of the top players in the pharmaceutical industry.

First, GlaxoSmithKline announced that they see little threat of generic competition for their asthma and COPD drug Advair® (fluticasone propionate and salmeterol inhalation powder) when it comes off patent in the US in 2011.  Noting that “it is very difficult to make a generic version of Advair,” GSK’s CEO, Andrew Witty, told the audience of a JP Morgan healthcare conference that “we are working on the basis of substantial Advair business for the foreseeable future.”

Shortly thereafter, in a separate announcement, the FDA noted that it completed the safety review of Pfizer and Boehringer Ingelheim‘s once daily COPD drug, Spiriva® (tiotropium bromide inhalation powder) and came to the conclusion that “available data do not support an association” between use of the drug and increased risk of stroke, heart attack or death due to cardiovascular causes.  The safety review was initiated in 2008 after data from a meta-analysis suggested a small excess risk of stroke compared with placebo.

Word on Health hopes that the new year will continue to bring good news for pharma.