Trinkets for docs

[ColoradoGuy]

A recently introduced federal bill (http://content.nejm.org/cgi/content/full/357/18/1796) follows the lead of several existing state laws and requires drug companies to report how much money they spend on gifts to physicians--everything from pizza, pens, and pocket calendars for the residents to free trips for the department chairs. It turns out this is quite a lot of money--19 billion/year, in fact. And, although docs claim this kind of thing doesn't influence prescribing behavior, research shows it does. Big Pharma is not stupid; they wouldn't spend the money unless they were getting a return for it. Actual regulation of this activity seems far off, and would in fact face some legal challenges, but the goal of this "sunshine bill" is just to let people know the enormity of the sums involved. It's a first step.

[kristie911]

It's a step in the right direction. Maybe if the freakin' drug companies didn't spend 19 mill on gifts and probably twice that on stupid televison commercials, maybe they could sell their products at prices the consumer could fucking afford.

[blacbird]

If this bill passes, I can guarantee a Bush veto. With some truly tortured reasoning expressed for it.

caw

[InfinityGoddess]

If this bill passes, I can guarantee a Bush veto. With some truly tortured reasoning expressed for it.

caw

Agreed.

[Higgins]

If this bill passes, I can guarantee a Bush veto. With some truly tortured reasoning expressed for it.

caw

Something about how the...the...the (very fast) free markets systems (note gratuitous plurals or idiopathic sluring) lives (note totally deranged emphasis on some randomly selected word)..it lives (as if explaiing or emphasizing but more likely just an attempt at imposing some kind of syntax on the state of being completely lost) on bribes (maybe he means this or maybe he doesn't) not bribes...it thrives (okay thrives is probably more what he thinks he might be saying)...it thrives (painful pause, painful repetition, apparently for the audience's benefit...but who knows?...this one man, this one "President" has buried more hopes about understanding how the human mind works than the last few decades of primatelogy) (and then very fast) a systems that gives free markets their needs (and then suddenly very slow and with a lot of rubato on the random emphases) and the decider has to say stop. And I say stop. (very fast) And that's why I have to veto this bill.

[robeiae]

The actual bill:

http://thomas.loc.gov/cgi-bin/query/z?c110:S.2029:

I don't understand the linkage to Medicare/Medicaid/SCHIP.

Also, I don't like this portion:

(A) IN GENERAL- The term `payment or other transfer of value' means a transfer of anything of value that exceeds $25, and includes any compensation, gift, honorarium, speaking fee, consulting fee, travel, discount, cash rebate, or services.
(B) EXCLUSIONS- Such term does not include the following:
(i) Product samples that are intended for patients.
(ii) A payment or other transfer of value made for the general funding of a clinical trial.
(iii) A transfer of anything of value to a physician when the physician is a patient and not acting in his or her professional capacity.If it's just "reporting," why exclude anything? Why leave those loopholes in there? And why the $25 minimum?

[ColoradoGuy]

If it's just "reporting," why exclude anything? Why leave those loopholes in there? And why the $25 minimum?
Half the pens and pads of paper scattered around nursing stations and on physician desks come from one drug company or another. Maybe it's a practical realization accounting for all those would be a nightmare, even more than the nightmare of the larger things. I assume the underlying intent of the whole bill is to make it such a hassle to keep track of it all that much of the gifting will just stop for that reason.

[robeiae]

Half the pens and pads of paper scattered around nursing stations and on physician desks come from one drug company or another. Maybe it's a practical realization accounting for all those would be a nightmare, even more than the nightmare of the larger things. I assume the underlying intent of the whole bill is to make it such a hassle to keep track of it all that much of the gifting will just stop for that reason.So, what's to stop a drug company from issuing each of their reps 1000 Am-Ex gift cards at $20 a piece? And don't all those supplies count as gifts that can have the very same kind of impact that is being addressed?

I'm just saying: if it's important, why do it half-assed?

[ColoradoGuy]

So, what's to stop a drug company from issuing each of their reps 1000 Am-Ex gift cards at $20 a piece? And don't all those supplies count as gifts that can have the very same kind of impact that is being addressed?

I'm just saying: if it's important, why do it half-assed?
I don't know, Rob, but that threshold for gifts is similar to other ones, such as the limits in at least one state I know on what a state legislator can be given without reporting--$25.00.

[robeiae]

I don't know, Rob, but that threshold for gifts is similar to other ones, such as the limits in at least one state I know on what a state legislator can be given without reporting--$25.00.
Do you think that state has curbed the "buying" of state legislators with its reporting requirements?

This whole thing strikes me as fluff, nothing more. But I expect little else from Congress, these days.

[Bravo]

CG,

are there any studies showing that doctors provid bad medications b/c they've been swayed by these trinkets?

i might be wrong, but i highly doubt it. i can see doctors being swayed by a friendly pharm rep b/c if he's choosing b/n very similar drugs (or the exact same drug as in clarinex and claritin). but does it really matter?

most doctors seem to either:

1) get annoyed by pharm reps visiting their office but agree to listen to their pitch b/c the rest of their office appreciates the free lunch or

2) develop a personal relation w the rep and when choosing b/n similar drugs would choose the drug that their friend is selling.

you might as well just get rid of the reps altogether then.

which isnt really advisable since doctors dont have the time to keep up w all the literature re: every single new drug that comes out.

like rob said, this seems like yet another waste of time for this congress.

[blacbird]

Do you think that state has curbed the "buying" of state legislators with its reporting requirements?

We up here in the enlightened far north have three legislators headed to prison on bribery convictions having to do with "gifts", another charged but not tried yet, and several more under serious investigation. They all have claimed the money they were given (in one case caught on video being handed wads of bills which he unceremoniously stuck in his pocket) were gifts and not really bribes. No matter, said the juries. And the IRS has yet to weigh in on the matter, but they're just waiting for the criminal cases to shake out before they do.

So, yeah, I do think these reporting laws have some value. Like any other laws, they require diligent enforcement, and they're never perfect, but I'd hate to contemplate a system for public officials without them.

caw

[ColoradoGuy]

Well, here's the gist of the issue. Drug companies give lots of free stuff to doctors, and this has been shown to make doctors more likely to prescribe the giving company's drugs. Unfortunately, a lot of prescriptions are written on the government tab, especially since the massive Medicare drug boondoggle/benefit (in which Bush specifically forbade haggling down the price of drugs using the governments enormous buying leverage). So the feds have a huge stake in this. At least one of the references in the linked NEJM article shows that doctors will, when "bribed" in this way, write for expensive brand-name drugs when cheaper generics will work just as well. So . . .

Doctors are stupid
Doctors are human
Drug companies are very, very crafty
If nothing's done Medicare will probably go bust even sooner than predicted.There's another article in this week's New England Journal (11/8 issue--you can't see it online without a subscription yet) in which the CBO predicts the cost of health care is the single most important determinant of the economic future of the USA.

So you got any suggestions?

[Bravo]

Drug companies give lots of free stuff to doctors, and this has been shown to make doctors more likely to prescribe the giving company's drugs. U

i dont have time right now to read the article, but if you can indulge me:

do the doctors give the "wrong" drugs b/c of this influence?

[blacbird]

i dont have time right now to read the article, but if you can indulge me:

do the doctors give the "wrong" drugs b/c of this influence?

There are degress of "wrong" potentially involved here. I know there have been allegations of doctors preferentially prescribing certain companies' more expensive brand-name pharmaceuticals when equally-effective and cheaper generics are available. And there are often various similar but not identical products available for certain uses, such as statins for blood-pressure, which may have variable side-effects and variable benefits, dependent on conditions with individual patients; doctors have been accused of preferentially prescribing a particular company's product when another company's drug might have been preferable, for medical reasons. And, of course, there's the matter of simple over-prescribing, making expensive prescriptions when such aren't really necessary in a given case.

As Colorado said, these companies aren't stupid, and they wouldn't be laying out this largesse without the expectation of important net returns for their effort.

caw

[Bravo]

i can see the doctors ordering a more expensive drug to be problematic if they said "do not substitute".

but otherwise, most pharmacists just give the generic brand.

[Shweta]

One doctor I had would always give away those freebies to his patients.

His reasoning was: "I know there have been studies that show that all these brandnamed pens and notepads have subconscious effects on doctors. I'd like to believe I'm immune to that, but I know nobody is. But they keep giving us this stuff. So here, have a pen, help me prescribe the right drugs instead of the ones I'm being primed to prescribe."

(A lot of these are drugs that don't have generic substitutes, by the way)

I loved that guy. He was awesome.

[ColoradoGuy]

CG,

are there any studies showing that doctors provid bad medications b/c they've been swayed by these trinkets?
Yes (http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=10294441&dopt=AbstractPlus) and yes (http://www.finance.senate.gov/press/Bpress/2007press/prb042507a.pdf). The free meetings and trips have been studied the most.

[Bravo]

okay thanks. i think a lot of the bigger gifts have been banned by the AMA though.

but i dunno, youre the doc so you tell me:

does it help to meet pharm reps?

and would you be willing to still meet w them if they didnt provide something for the office or you?

[ColoradoGuy]

okay thanks. i think a lot of the bigger gifts have been banned by the AMA though.
The AMA has no legal authority to ban anything. And a lot of docs don't belong to the AMA--I don't.
does it help to meet pharm reps?
In my opinion and 30 years of experience, no--never.
and would you be willing to still meet w them if they didnt provide something for the office or you?
I have always refused to meet with them, primarily because such "detail people" (as they're called) are low-level folks with no useful scientific insight. And they're trying to sell me something.

[Bravo]

okay got it.

case closed.

i dont think this needs to be legislated, but since its not like there's a war to stop or anything major to solve i guess they might as well go pass their sunshine bill.

(and i did think the AMA banned accepting large gifts for their members, but im not sure where i heard that from)

[ColoradoGuy]

okay got it.

case closed.

i dont think this needs to be legislated, but since its not like there's a war to stop or anything major to solve i guess they might as well do pass their sunshine bill.
Yeah, but the problem is still there, and it's huge. Physicians writing Medicare and Medicaid prescriptions are analogous to government contractors, and the money they are spending with the prescriptions is the taxpayers' money.

[illiterwrite]

Interesting. I worked for a medical communications company in Toronto for 6 or 7 years. Our big thing was "conferences" for doctors -- in sometimes exotic locations (Jamaica, Mexico, Europe), sometimes just "away" (in the mountains, down to California or Arizona). The hotels were always swanky. The doctors were paid well. There were usually 2 half-days of talks, followed by golf, spa, dinners, shows (in Las Vegas), etc. Plus the doctors expensed whatever they wanted. Once a doctor bought a new leather jacket and the pharma company paid for it. Certain doctors were known as pharma whores -- that is, they'd pretty much say anything about a drug if they were paid enough. Two doctors spoke often and charged $10,000 to speak. They got it. I heard a story about one doc who threatened a rep, saying that if he didn't get what he wanted (and I can't remember what it was, exactly), he'd start a smear campaign about the drug.

And the stories go on and on.

[ColoradoGuy]

Yep.

[Perks]

i dont have time right now to read the article, but if you can indulge me:

do the doctors give the "wrong" drugs b/c of this influence?I'll give you an example of something kind of odd. I took my daughter in to the pediatrician for a case of pink eye. (I now know that 'pink eye' is mostly viral and you don't really need to anything about it unless it drags on or is seriously bothersome. And scarily, the best pink eye remedy? Breast milk. No lie. It's astounding.)

Anyway, my pediatrician had a pen and a notepad with a drug name on it, which he prescribed - Vigamox. At the pharmacy, and even after my insurance, a tiny, tiny, teeny bottle of this stuff was $60.

But what did I know. The doctor said she needed it.

Later when I mentioned this to my friend, a toxicologist high up in the FDA, he said, "Vigamox?! What the hell for? A little garden variety pink eye? That's heavy duty stuff. It's a nuclear bomb."

So, she arguably needed no drug at all and certainly not both barrels, but my doctor had a stack of gewgaws from the Vigamox people and was prescribing it all over the place.

[blacbird]

i can see the doctors ordering a more expensive drug to be problematic if they said "do not substitute".

but otherwise, most pharmacists just give the generic brand.

Every pharmacist I've ever gone to has taken the prescription, said something like, "Come back in about a half-hour," and walked away. They don't substitute doodly-squat. It's not their job. Prescribing is the job of the physician. Them, I've had ask me if I want a generic alternative.

But it's not hard to envision geriatric patients, poor patients, uneducated patients, being intimidated by this sytem, and victimized.

caw

[Bravo]

ive had a different experience.

i sometimes have to fight so that they dont switch it to a generic.

[ColoradoGuy]

I'm not aware of any data anywhere that shows a difference in action or outcome between a brand-name and a generic version of the same drug. If you know of any I'd love to read about it. (And only peer-reviewed stuff in reputable journals counts, not drug company puffery.)

[brokenfingers]

Perks bought up the exact issue I was going to address in response to Bravo's question if "there any studies showing that doctors provide bad medications b/c they've been swayed by these trinkets?"

While I don't know if there have been any actual studies done per se, I do have a lot of anecdotal evidence that they can be quite overzealous when handing out prescriptions.

I've heard many stories with children, which I think is especially heinous since the long term effects of new drugs are relatively unknown as far as children go.

[Bravo]

I'm not aware of any data anywhere that shows a difference in action or outcome between a brand-name and a generic version of the same drug. If you know of any I'd love to read about it. (And only peer-reviewed stuff in reputable journals counts, not drug company puffery.)

i never said there was any data about this....????

all i said was that pharmacists change the prescriptions all the time.

but anecdotally, the generic brand for a certain brand seemed to always to give me a mild adverse reaction.

when i went to a new pharmacist, they automatically used the generic even though the doctor had put the name brand on the form. they didnt ask me, they just did it.

so i told them to switch.

and after a bit of a discussion, they did it, and voila.

no adverse reactions.

who knows why that was.

but that's really beyond the scope of this discussion. all i was saying was that pharmacists routinely switch to generics so sometimes it doesnt really matter what the doctor prescribes.

[ColoradoGuy]

all i was saying was that pharmacists routinely switch to generics so sometimes it doesnt really matter what the doctor prescribes.
They are allowed to do this unless the Rx reads "do not substitute" on it. It's usually a check-box on the form--unless checked, the pharmacist may substitute a generic if one is available.

[Bartholomew]

One doctor I had would always give away those freebies to his patients.

His reasoning was: "I know there have been studies that show that all these brandnamed pens and notepads have subconscious effects on doctors. I'd like to believe I'm immune to that, but I know nobody is. But they keep giving us this stuff. So here, have a pen, help me prescribe the right drugs instead of the ones I'm being primed to prescribe."

(A lot of these are drugs that don't have generic substitutes, by the way)

I loved that guy. He was awesome.

My father got free medicine all the time because his doctor would give him wads of samples. I still have a bunch of the packets. :-/

He did this because my father was living on high doses of morphine and he knew we couldn't afford the other medicines he needed. A pharmaceutical company, on a superficial level, supplied my father with free stomach medicine for something closing on four years.

I have definite mixed feelings about restricting how much a drug company can gift a doctor.

[illiterwrite]

I thought that, because generics don't have to undergo the same kind of testing prior to launch, there could be safety issues with them. I don't have any hard data to back that up, but I do recall a bunch of physicians talking about the problems associated with an automatic switch to generics.

[Mac H.]

I thought that, because generics don't have to undergo the same kind of testing prior to launch, there could be safety issues with them.
'Generic' drugs are approved in the USA under the 'ANDA' process instead of the full process.

So if I want to make a brand of Asprin, I can use the ANDA process and avoid repeating the clinical trials to prove that aspirin is safe and affective - instead I simply list the existing studies.

To use the 'generic' route, the dosage form, strength, method of administration, qualityd, performance characteristics and intended use have to be equivalent.

The bio-equivalence tests for generic drugs is IDENTICAL to the tests that brand-name drugs have to do on reformulation .. so there isn't a difference there.

So if I do a generic version of a Bayer drug, I have to jump through the same hoops as Bayer does if they decide to make a minor tweak in the manufacturing process .. even down to changing the physical equipment they use in the factory! (Replacements of individual components & repairs to physical equipment aren't considered changes)

The drug manufacturers agreed to the rules to allow generics to be easily made in return for an extra 5 years or so of patent protection on their existing drugs.

Changes between brand name drugs and generics are mainly the inactive ingredients .. such as binders and fillers. However brand name drugs can make the same changes to their pills with the same process .. so there isn't really a difference in protection. For example, one brand of tablet may contain gluten, another may be gluten free.

Mac