AMA Reaffirms The Right To Off-Label Prescribing
14 CommentsBy Ed Silverman // November 8th, 2007 // 11:41 am
The big physicians group meets this weekend in Honolulu to review and decide a variety of policies, such as ensuring affordable health insurance for patients with expensive medical conditions; trends in employer-sponsored health insurance; guidelines for evaluating state proposals for health system reform and ethical considerations regarding umbilical cord blood banking.
Along the way, the AMA delegates will also vote on resolution 918, which essentially continues an earlier policy that permits docs to prescribe off-label when they see fit. Although drugmakers can get into hot water for off-label promotions, off-label prescribing by doctors is, of course, a widely accepted practice. To learn more about the AMA position, though, you can read the resolution here.
Ken Thomas, RN
Wow! What arrogance. I would not want my MD prescribing meds to my kids off-label. Why? Because they DON’T know the full scope of the long-term effects. I don’t believe they are better suited to judge the benefits vs negatives in each drugs case. Why would I say that? Because I know how MDs get their drug action details….via the Drug Rep or the finely crafted promo piece that doesn’t have all the facts on it. I WISHED they would actually all read the original, double-blind, authenticated research papers for their conclusions, and before they are “doctored up” by the manufacturer paid lead researcher, but that isn’t the case.
Melody
Ken–
Why would you say such things? Doctors know EVERYTHING. (As a matter of fact, there are a couple who post here who continually assure us that their judgment and intellect is irreproachable! They are too knowledgeable and ethical to EVER be influenced by AMA dogma or pharma marketing or pseudo-science.) Surely doctors wouldn’t lie to us, would they? They wouldn’t prescribe off-label unless they had assurances from respected researchers and experts that this was approproiate. (They wouldn’t just take the word of one of their brethren that “it worked for me–try it”–would they? They scrupulously vet every article and author they read to establish scientific integrity, right?)
Get off these poor souls’ backs! They work HARD . . . they spend YEARS and vast amounts of money to attain their god-like status. They certainly don’t need non-doctors (you and me, perhaps) questioning them or their methods. Trust them . . . haven’t they EARNED your trust?
James
Yes–we certainly should never have doctors prescribing anything unless it is for the gov’t approved purposes.
After all, federal gov’t employees know more than our doctors, working with us, know about what is good for us and our bodies.
I trust the government to make all my decisions for me. Don’t you?
Lisa Van S
James,
Moseholder or Emslie,….Hmmmm.
Integrity,..Honesty. Its a no Brainer, and FDA’s Moseholder wins it,hands down.
strayze
My life depends upon off-label prescribing, for I have a
rapidly progressive rare and fatal disease. It is not
possible to test drugs for rare conditions for there is
not a statistically suitable patient base. In addn the
speed of decline leaves no room. My drug is not substi-
tutable with another drug. The kicker is that Medicare
D does not allow off-label prescribing. That means that
I’m a dead duck. There are no drug plans that are not
based upon the deadly Medicare D. That leaves me with a
$34,000 drug bill every year. All “help with drug costs”
plans, as well meaning as they are, cannot help with my
off-label drug because of Medicare regs.
Bob Freeman
Strayze, your plight is difficult and reflects fact that private and public programs are resistant to cover “experimental” therapies. One of the problems is, of course, rare conditions are not profitable for companies to pursue. The other is due to the fact it takes time for studies to be presented and published in the medical literature–If you can cite studies that goes a long way to establish that the prescribing is appropriate, not experimental. In other words it’s not just the labeling that’s considered but the total body of knowledge surrounding the disease and the drug’s use.
TOdd
strayze, your story definitely is the poster for why this is wrong. And I am with you 90% of the way. But if this is a true story, all it takes is 2 clinical trials and then there is really no way that anyone would turn down a prior auth. Also contact the manufacturer about PAP.
But I get the point, off label prescribing is the world we live in. Plain and simple.
So Ken you don’t trust someone who went to school for 11 years, but you would rather rely on your 2 year community college RN? You didn’t have to take logic at the JUCO did you? Arrogance is thinking the guy you take orders from all day knows less than you.
Lisa Van S
Todd,
Have an R.N. behind your name? 17 Years ago an R.N. saved the life of my son who could have died from Kawasaki’s Disease, a Disease that went undiagnosed by several Physicians, who appeared quite baffled by the symptoms of this rare, but potentially life threatening Disease. What would Docs do without Nurses, who have, and will continue to save their “BUTTS”
Some times,… Some things,.. are better left unsaid!!…
Hank
Anyone know what percentage of ’scripts are off-label? It’s got to be very high.
Atlex
Hank, it’s hard to know what percent of scripts are “off-label” for a couple of reasons. First, and foremost, scripts typically are not attached to diagnoses and must be linked back to diagnosis via database analysis. Most such analyses suggest off-label use of 50% or more However, that’s somewhat misleading. The vast majority of off-label use is for treatments that have been readily accepted into the medical community. Typically, these indications are in the medical literature or in medical compendia.
Strayze’s issue must be that his condition is not listed in a medical compendium; otherwise, his medication would be reimbursable by Medicare Part D.
Lori
Hank -
This figure is very difficult to track at the industry level. Most of these estimates are done at the drug or class level. Some products have almost all off-label usage; others have negligible or no off-label usage. I have worked on a couple of different products where off-label use was 50-60%.
The other consideration about off-label usage is that it is not all the same in terms of risk and safety. As I am sure you are aware, some off-label prescribing causes major health concerns while other off-label use is considered standard practice.
Bob Freeman
Hank and Atlex, I agree it’s hard to get an accurate figure because diagnosis does not appear on the prescription and it’s not always clear if it’s off-label.
However, fairly reliable data I have seen suggests that oncology drugs’ off-label use is as high as 70-75%. Is that bad medicine? absolutely not in my opinion especially in advance stages (III and IV).
TOdd
Lisa, let’s exchange education. You first….
Any college at all, HS diploma, a JUCO class or two?
Hank
Thanks to folks re: off-label use question. Those are roughly the stats I was imagining, and with the qualifications and provisos you included.
At the (risk/certainty) of stretching a point, perhaps there is a parallel between who can contribute to discussions like this and “off-label” use. Having “official” degrees, training, and experience is obviously tremendously useful for certain aspects of certain topics. Consumers as stakeholders can also bring a variety of “off-label” expertises - political, experiential, activist-grounded knowledge, etc. - to the table.
It seems to me important on all sides (1) not to pretend to know more than one does, (2) to acknowledge fallibility (i.e., non-omniscience)_whatever_ one’s background, (3) to aim toward learning from, or appropriately correcting, each other rather than knee-jerk dissing.
Again, on all sides.