The U.S. Food and Drug Administration (FDA) draws a distinction between direct-to-consumer advertising for pharmaceutical products, which it regulates, and advertisements meant to create disease awareness, which it does not regulate. Most other countries ban direct-to-consumer advertising because it can be misleading and may interfere with the doctor-patient relationship. Challenges arise when disease awareness efforts are made for a condition for which there is only one drug available for treatment. In this case, raising awareness of the disease may also raise the use of the one product available. This year a novel approach to disease awareness promotion has caused a number of questions to be raised regarding this type of marketing.
General Hospital is the longest-running U.S. soap opera. The producers of the show formed a partnership with Incyte, a pharmaceutical company that manufactures only one product, Ruxolitinib, which is used to treat myeloproliferative neoplasms (MPNs). MPNs, which are cancers that affect the bone marrow, can cause an overabundance of white blood cells (leukemia), red blood cells (polycythemia vera or PV), and platelets (thrombocythemia). Ruxolitinib treats the genetic mutation that causes PV. Due to their partnership, the producers of General Hospital created a plotline where a character on the show was diagnosed with PV. When faced with the various means of treatment the character chose to take Ruxolitinib.
There are several problems with this plotline. First of all, it is essentially direct-to-consumer advertising. PV causes the blood to thicken due to too many red blood cells, which can lead to blood clots. First line treatment of PV involves anti-clotting medications and regular blood donation (yes, believe it or not this amounts to medieval bloodletting). A drug called hydroxyurea is often used to reduce the bone marrow’s output of red blood cells. Ruxolitinib is not first line treatment of PV and is only used in selected cases where the preferred treatment doesn’t work or is ineffective. So the show’s storyline is misleading. In addition, increasing public disease awareness is said to improve outcomes by having patients seek care earlier in the disease. But this is plausible for common diseases that may otherwise go unrecognized or for diseases in which early treatment is superior to delayed treatment. MPNs are in fact rare and PV is even rarer still. PV is often diagnosed by either the patient suffering a blood clot or having it picked up on routine blood testing.
In the U.S., drug company advertising reached the highest annual spending in 2016, amounting to $5.6 billion for the year. Advertisements are appearing for specific drugs and unprecedented indications. There were even TV ads for topical antifungal medication and treatment for irritable bowel syndrome during the 2016 Super Bowl. Imagine what that cost! Ultimately direct-to-consumer advertising amounts to a massive medical intervention with unproven health benefits, dubious plausibility, and may indeed lead to harm, but unfortunately it is probably here to stay. By the way, in case you were wondering, the information for this column came from a medical journal. I don’t watch General Hospital!
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