Samples Don’t Reach Poor Kids & Have Safety Risks
8 CommentsBy Ed Silverman // October 6th, 2008 // 1:09 pm
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).
Christopher
Presumably only those children who attended a doctor’s office or clinic were able to receive samples so that levels the playing field (cliche) right there. So presumably and regardless of economic standing kids receive samples consistently ie 1 in 10 of prescription recipients. Who assumed that the purpose of samples was to benefit the less well-off? Critics may well believe that sampling higher cost meds distorts the purpose but in whose mind? Who defined that as the purpose of sampling? What if less well-off kids need newer, higher cost medications? Diseases and conditions do not select for bank balances. Should they receive the cheap stuff? Of course not. This is why ‘critics’ and ‘observers’ need to be read with a certain ammount of circumspection.
Ed Silverman
Hi Christopher,
Good points. I won’t speak for critics or advocates, only myself. And samples were designed for various purposes, no doubt. I wrote what I did in the opening line of the post simply because I’ve heard from doctors that being able to offer samples to patients who may not otherwise be able to afford certain meds can be helpful. And I would think that would be a good thing. I agree with your last point about diseases not choosing bank balances. Perhaps another study is available or will be conducted to examine the extent to which expensive meds are sampled.
Thanks for stopping by,
ed
Christopher
Ed,
I agree with you and would advocate at all times for samples to be made available to less well-off families. (For the same reasons I supported for children to be included in GSK’s Argentina pneumonia study because it brought healthcare to those who otherwise would not have it. Simple as that.)
My point was, as you probably know, that critics and nay-sayers can squeeze the good from anything - including free medications - to support their self-serving point of view. That’s what annoys me. A little bit like the current political menagerie in the US where good ideas are sacrificed because somebody wants to make a point.
Like me I suppose but I’m not standing in the way of free meds for children.
Annette Kreuger VP Pharma-Biotech Group Industrialinfo.com
Right off the bat in exposing poor and/or uninsured to unproven or possibly dangerous new meds-people need to get over it. Virtually every drug poses a danger to someone in varying degrees and if the marketing campaign was sucessful enough, policyholders are being prescribed said unproven drugs. Meds are overprescribed as it is-rich or poor. Granted there is a different level of prescribing methods between different tiers of care (i.e. a private physician vs. a clinic setting). Not sure why this is, perhaps those in private practice are more aware of new developments. Of course, new does not always equate better.
It just proves that even within the insured there are different levels of care received.
It benefits everybody if a child’s health is taken care of. The uninsured and/or poor have a tendency to stay away from traditional pediatrician’s offices, choosing instead the emergency room when the situation becomes dire (or strangely enough, somehow worse when it is not a emergency). There are those who will rail against “them” getting something free while “we” presumably taxpaying insurance card carriers have to pay. This is ridiculous. Beyond the humanitarian aspect of a child being helped, the pure cynics should understand that a healthy child will cost them less in the long run.
harpy
“Diseases and conditions do not select for bank balances. Should they receive the cheap stuff? Of course not.”
Christopher - Are you falling prey to the delusion that “cheap” means ineffective? In many cases “cheap” means “on-the-market-for-a-long-time-with-understood-side-effects-and-efficacy.” I would have to be hard pressed to give my child a medication that just came on the market, knowing what I now know about pharma. Not to mention that the vast majority of drugs that are sampled haven’t been tested on children.
But tell me, what is the purpose of sampling? Why would a drug
deacompany want someone to try their product? As we’ve been told many times before, it isn’t out of the goodness of their hearts - it’s to make a sale. Pharma companies are out to make money –> drug samples get people to take their high-priced “new” drugs –> pharma makes money.Christopher
harpy - no I’m not falling into that one although I can see how my sentence could have given that impression. What I tried to communicate was that all children should have access to all suitable samples, regardless of economic standing.
Would be interested in your statement that “…the vast majority of samples haven’t been tested on children.” On what is that based? Do you mean samples in general or samples intended to be used by children? Makes a difference I think.
We both know the purpose of sampling. You don’t need a response on that, but perhaps amidst the profit motive which obviously is - and should be - present there might be some good coming from sampling if it means that some kids receive medicines which they otherwise would not have a chance to take.
Meg
Well, this is a surprise. Knowing the over-use of psychotropic drugs for children in state care (Governor Palin is currently being sued for this very thing), I just assumed that the possibly less-knowledgable, Medicaid-eligible child was the prime target for new samples, particularly psychotropics. On the basis of this information, it looks like my assumption is wrong. I was thinking of Rebecca Riley in particular, the little girl killed by a psychotropic cocktail in Boston at the age of four.
harpy
We have this from the article - “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”
And the difficulty of doing pediatric clinical trials leads to information being extrapolated from adult trials, which is flawed because children are not miniature adults. I don’t trust any new drug - for adults or children - to be properly understood as to the risks and benefits. I’ve seen too many articles and court cases on data manipulation to trust either pharma or FDA. That’s my issue and I’ll err on the side of caution.
I think we agree, Christopher, that children ought to have access to medicines they need - but you think samples are ok and I don’t. If it came right down to it, I would prefer to give kids the medications they need and not have to rely on the largesse of pharma.