In an ideal world, free samples would help uninsured patients get a jump on treatment they may not otherwise be able to obtain. But a new study in Pediatrics finds that free samples are not making their way to poor and uninsured children and, moreover, pose significant safety considerations (here is the abtract).
The researchers analyzed data on 10,295 US residents who were younger than 18 years old from the 2004 Medical Expenditure Panel Survey, and found 10 percent of children who received prescription meds - and 4.9 percent of all children - received one free drug sample that year.
Specifically, kids whose family incomes were below 200 percent of the poverty level, were no more likely to receive free samples than those with incomes of 400 percent of the poverty level (3.8 percent vs 5.9 percent). Children who were uninsured for part or all of the year were no more likely to receive samples than were those who were insured all year (4.5 percent vs 5.1 percent). And 84.3 percent of all sample recipients were insured.
The 15 most frequently distributed pediatric free samples in 2004 included two schedule II controlled substances - the Strattera and Adderall ADHD pills - and four meds that received new or revised Black Box warnings between 2004 and 2007 - the Novartis Elidel ezcema treatment; Glaxo's Advair for asthma, and Strattera and Adderall.
The findings will likely exacerbate the debate over samples, which drugmakers widely use as promotional tools while arguing that patients can save money and doctors can determine whether a med works before prescriptions are written. Critics, however, say expensive meds are more widely sampled, which distorts the purpose.
The lead author, Sarah Cutrona, a Harvard Medical School instructor, says samples tended to be the newest, so safety had often not been thoroughly vetted. Samples also often lack instructions for children or info about what parents should do in the event of an overdose. “We need to discuss it more and maybe consider stopping the use of free samples entirely, if there are such potential harms," she tells The New York Times.
Ken Johnson, senior vp at PhRMA, tells the paper that "free samples have helped improve the quality of life for millions of Americans, regardless of their income.”
Last month, a retrospective study in the Southern Medical Journal found that free drug samples provided by drugmakers to doctors could actually be costing uninsured patients more in the long run (back story).