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.

A Bad Break for PPIs

A question for all our orthopedic, primary care, emergency medicine and physical therapy readers. When your patients come into see you with fractures do you ask them about their stomach?  No! – Well, maybe you should.  According to a recent meta-analysis, some of the drugs most commonly used to treat acid reflux can lead to fractures.

This is no small problem.  Millions of people worldwide are currently using these medicines often on a long-term basis. Each year sales of such drugs top $30 billion.

The type of medicines we’re talking about are more commonly known as Proton Pump Inhibitors (PPI) or Histamine-2 receptor antagonists (H2RAs). Among the former group are the best sellers such as Prilosec, Prevacid, and “the purple pill”- Nexium.  Among the latter: Tagamet (cimetidine) and Zantac (ranitidine). many are available over-the-counter.

The authors of the meta-analysis found that PPIs, which block acid production by up to 98%, are associated with an increased risk of both hip and any type of fracture. On the other hand, no significant relation was found between the H2RAs and fracture risk. Interestingly, H2RAs block only 70% of gastric acid production.

It’s thought that bone fractures resulting from the use of PPIs are due to defective calcium absorption.  This can lead to hyperparathyroidism which in turn may modify acid-related enzymes in bones.

Given the widespread use of PPIs this study has great importance to public health. Clinicians should carefully consider their decision to prescribe PPIs for patients, especially the over-50’s who already have an elevated risk of fracture, and the orthopedic / emergency medicine community should routinely question their patients about the use of such drugs.