Sniffing Out Leukemia?

3 doctorsOK Ladies – here’s a question for you.   If you suffer from seasonal allergic rhinitis who do you go and see?

(a)  An allergist

(b)  An oncologist

(c)  A hematologist

If you answered (a) you’re probably feeling pretty confident right now.  After all the more common term for seasonal allergic rhinitis is hayfever and that’s something best managed by an allergist.  Right?

Not so fast! Maybe (b) or (c) would have been better choices.  You see, a team of scientists looking into the interplay of the immune system and cancer have just found a link between a history of airborne allergies – in particular those to plants, grass and trees – with risk of blood cancers in women.

Notably, the study did not find the same association in men, which suggests a possible gender-specific role in chronic stimulation of the immune system that may lead to the development of hematologic cancers.

The findings were published online last week ahead of the December print issue of the American Journal of Hematology.

allergic rhinitisTo the best of our knowledge, ours is the first study to suggest important gender differences in the association between allergies and hematologic malignancies,” says Mazyar Shadman, MD, from the Fred Hutchinson Cancer Research Center.

According to Shadman, who led the research, the immune system’s potential role in the cause of cancer is a focus of intense scientific interest. “If your immune system is over-reactive, then you have problems; if it’s under-reactive, you’re going to have problems. Increasing evidence indicates that dysregulation of the immune system, such as you find in allergic and autoimmune disorders, can affect survival of cells in developing tumors.”

The study included a large sample of men and women aged 50-76 years old from western Washington from the VITamins And Lifestyle (VITAL) cohort study. Participants answered a 24-page questionnaire that focused on: (i) health history and cancer risk factors, (ii) medication and supplement use, and (iii) diet. Participants provided information on age, race/ethnicity, education, smoking, diet (fruit and vegetable intake), and other lifestyle characteristics, self-rated health, medical history, and family history of leukemia or lymphoma.

History of asthma and allergies was also taken, including allergies to plants, grasses or trees; mold or dust; cats, dogs or other animals; insect bites or stings; foods; and medications.  Of the 79,300 VITAL participants who filled out the questionnaires, more than 66,000 individuals were selected after eliminating those who had a prior history of malignancies other than non-melanoma skin cancers and missing information on baseline cancer history.

Participants were then followed for eight years until they either withdrew from the study, moved away, had a cancer diagnosis other than hematologic malignancy or non-melanoma skin cancer, or died.

seer_logoIncidence of hematologic malignancies and other cancers was identified via the Surveillance, Epidemiology and End Results (SEER) cancer registry of western Washington.

Of the participants, 681 developed a hematologic malignancy during the follow-up period. These participants were more likely to have two or more first-degree relatives with a family history of leukemia or lymphoma, to be less active and rank their health status as low.

A history of allergies to airborne antigens was associated with a higher risk of hematologic malignancies. The most statistically significant association was seen with allergies to plants, grass and trees.

cat allergyThere was also an increased risk of plasma-cell neoplasms for participants who reported a history of allergies to cats, dogs or other animals. Plasma-cell neoplasms are conditions, both cancerous and noncancerous, in which the body makes too many plasma cells.

When stratified by gender, the incidence of blood cancers in response to these allergens was increased in women but not in men. The reason for this is as yet unknown.

However, Shadman and colleagues warn, “Given the limited number of cases within each sub-type of hematologic cancer, the risk estimates need to be interpreted with caution … and the possibility of chance finding due to multiple testing should be recognized.”

Even so, if you’re a women with allergies, you may want to keep a close eye on your blood work.

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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.