Pharmalot... Pharmalittle... Good Morning

Rise and shine, everyone, another busy day is on the way. We, however, have something of a respite this morning, if only because the local schoolhouses are closed this week, which means the short people are sleeping in. As a result, we have more time to devote to rummaging for fascinating developments. This calls for celebration, so please join us as we hoist another cup of stimulation and dig in for another interesting session. Hope your own goes well and you conquer the world. Meanwhile, do stay in touch...

Almost One-Third Of Chemotherapies Are Used Off-Label: Study (Reuters)

US Deaths From Overdoses Up For 11th Consecutive Year (Los Angeles Times)

Allergan's Botox Put Boy On Respirator, Jury Told (Bloomberg News)

Peregrine Reports Less-Promisiing Revised Lung Cancer Drug Data (Reuters)

Takeda Cracks Down On Suspended CMO Plant (Outsourcing Pharma)

Glaxo And Isis Rare Drug Disease Moves To Phase II/III (Pharma Times)

Gilead And Teva Settle Viread Patent Suit (Bloomberg News)

Jury Ends First Day Of Deliberation For J&J Mesh Implant Trial (NJ.com)

EDITOR'S NOTE: Please check this post for additional items during the day

sunrise pic thx to benimoto on flickr

36 Comments

Feb 20, 2013 - 9:14am
Ed, thanks for posting the story on Rx painkiller fatal OD's. Too bad it took almost 100 posts on this very same subject to prove that I was right, as per usual.
Feb 20, 2013 - 9:28am
OII - those fatal OD's don't matter if it inconveniences someone.
Feb 20, 2013 - 9:31am
OII, I think the key unanswered question remains how many of these overdoses are due to addicts and recreational users substituting prescription painkillers for heroin. Data from New Mexico shows that illicit drug overdose deaths, which more than doubled between 1990 and 1999, have remained approximately flat since 2000. This is the year in which the "prescription drug epidemic" began.

Graphing total drug overdose deaths, one gets a straight line going all the way back to 1990. To me this suggests that heroin and Rx painkillers are being used interchangably by recreational users, and that restricting painkillers will increase heroin deaths in direct measure with the number of Rx painkiller deaths prevented.

Feb 20, 2013 - 9:31am
Sorry OII, here's the link

http://www.nmlegis.gov/lcs/handouts/LHHS%20091012%20Michael%20Landen%20State%20Epidemiologist%20Prescription%20Drug%20Overdose%20Deaths%20in%20NM.pdf

Feb 20, 2013 - 9:42am
MC, I know you guys have been in a pretty heated debate, but having a chronic pain pt in the family, I'd call lack of access to appropriate pain medication an "inconvenience" in the same sense as having a neighbor who breaks out all the windows in your house once a week. I don't think the word quite adequately captures the experience.
Feb 20, 2013 - 9:50am
John2,

Take a look at the graph on page 2 here and tell me that opiate overdose deaths are shifting from heroin to Rx painkillers. This is national data, not what is happening in one state.

http://www.cdc.gov/homeandrecreationalsafety/pdf/poison-issue-brief.pdf

Feb 20, 2013 - 10:08am
Guys you are splitting hairs here. The same dope dealers in Newark, Camden and Paterson who will sell you heroin will also sell you oxycontin, vicodin, Xanax, or whatever is your pleasure. You can be a junkie or a legitimate pain patient, it DOESN'T matter.

You are all debating how many angels can dance on the head of a pin. Stop already, you will never solve the riddle or be able to tease apart the problem so that only pain patients get their rightful supply to the TOTAL exclusion of the junkies. That's why this baby needs to get thrown out with the bathwater, and go back to square one to figure out how we can focus the drug supply on those who really need it.

Feb 20, 2013 - 10:30am
Thanks for the data MC.

NM has the highest rate of deaths from drug overdose in the US. I agree that its not national data, but it is the only source I have been able to find that goes back pre-1999.

I also agree that the data that I provided is suggestive rather than iron-clad proof of my hypothesis. That's in the nature of any sociological data I'm afraid. I'm not trying to be dogmatic here, just offer a different POV.

The CDC graph shows flat heroin overdose deaths since 1999. The NM Dept of Public Health data shows that between 1990 and 1999 (years not covered by the CDC data), heroin overdose deaths and total overdose deaths each increased by a factor of about 2.5, corresponding to a compound annual growth rate of 11%.

In 1999, the growth in heroin overdose deaths suddenly grinds to a halt, and the "prescription painkiller epidemic" begins. From 1999 to 2010, the overall rate of drug overdose deaths increases about 1.6-fold in NM (4.3% CAGR), and about 2.2-fold nationally (7.4% CAGR).

I recognize that there are lots of ways to view this data, and that a key part of interpreting it involves asking why drug overdose deaths are increasing both before and after 1999, and whether the same factors are in play.

My personal view is that all historical efforts to reduce drug abuse by controlling supply have failed miserably, and by extension, that the growth in drug overdose deaths cannot be explained in terms of increased supply.

I recognize that intelligent people may have very different views on this, and that the data are incomplete.

Feb 20, 2013 - 10:35am
...and of course my main point, that one cannot blame increasing drug overdose deaths on the increased availability of prescription painkillers, as the growth rate of drug overdose deaths was as high or higher in the decade prior to the current "epidemic".

My position on this is not set in stone, but I think it is as reasonable an interpretation of the available data as many others. I don't think the growth in overdose deaths since 1999 should be viewed in isolation from prior trends.

Feb 20, 2013 - 11:05am
John2 - I follow you and let's say that your hypothesis is correct - I'm not sure that we should take a lot of satisfaction in that we are allowing prescription drugs to kill people that used to die from illegal drugs.

What we really need to know is if the increase in deaths from prescription opiates is due to people who have been prescribed them or people who have obtained them illicitly. I agree that it is difficult ot impossible to prevent overdose deaths in those that use illegal drugs OR obtain Rx drugs illicitly. But if the increase involves people who have been prescribed those drugs we have a big problem.

Feb 20, 2013 - 12:27pm
MC we have a huge problem. Go back to my link to the DAWN data or look it up. You'll see that many overdoses occur among legitimate pain patients with a legitimate Rx.
Feb 20, 2013 - 5:10pm
OII can you repost your link?
Feb 20, 2013 - 5:45pm
So while awaiting OII's link I ran some numbers.

According to the CDC, there were 15,000 prescription painkiller deaths in 2008 and approximately 12.3 million recreational users of prescription painkillers.

It seems somewhat reasonable to assume that the annual risk of death from overdose for an average legit user is less than or equal to the risk for a recreational user. We can set an approximate upper limit to the risk of a recreational user by assuming that 100% of overdose deaths occur within this subgroup of opiate users. The estimated upper limit for annual risk then comes to 15,000/2,300,000 = 0.12% or one in 825.

Approximately 30,000 Americans die in auto accidents each year (apologies for using this stat yet again), or about 0.01%.

My ballpark guess is that the risk of fatal overdose for a legitimate opioid user is about 5x that of driving a car, and probably a little less than bungey jumping or amateur car racing. To me this falls in the range of warning people and allowing them to decide if they want to assume the risk. But that's a value judgment, and I'm sure others will have different opinions.

Also the CDC notes that methadone is implicated in about a third of these deaths. As I understand it, methadone has been prescribed a lot for pain because it is considered "abuse resistant", but it has odd, non-linear pharmacokinetics that make it unusually easy for chronic pain patients to OD on (Saturation of metabolizing enzymes, if I recall correctly). That might be worth looking into, especially for someone like MC who is in a position to influence policy.

Feb 20, 2013 - 6:40pm
Sorry for the delay gents. I had to scroll through the bilious chortling of our resident anencephalic.

http://www.drugabuse.gov/publications/drugfacts/drug-related-hospital-emergency-room-visits

Feb 20, 2013 - 7:33pm
Good reference OII.

I don't know what to do about it.

In many ways I'm a shameless liberal, but it kinda makes me mad how much suffering was endured by my family because the default expectation is that anyone who claims to be in pain is lying and is going to chase their painkiller Rx down with vodka and a joint on their way to pick up a hooker.

I guess I should stop being surprised when things suck.

Feb 20, 2013 - 7:33pm
Other Data Sources @oii - cut and pasted from your link - last paragraph:

"* DAWN relies on longitudinal data collected from selected hospitals across the United States. Beginning in 2004, DAWN adjusted its sampling and weighting methodologies in order to improve the quality, reliability, and generalizability of its estimates. Thus, trends reported earlier than 2004 cannot be compared to more current estimates due to changes in the DAWN data collection reporting system. ** The abuse of pharmaceuticals (prescription and over-the-counter medications) is also referred to as “nonmedical use.”..."

This data is still "raw", meaning you have to drill down to get actionable data for "hot-spotting".

With 1 in 6 people currently living in USA at or below a poverty level even when working 2 or more "part-time" jobs, and 40 million without health insurance and donut-holed out of government assistance, is this increase because of how the "working poor's" aches and pains are being managed? Opiods can't be sold to the patient as better than off-the-shelf non-opiods, can they?!

Need a break out of demographics to explain the huge increases.

Feb 20, 2013 - 8:17pm
Here's some of the demographics:

The rates of ED visits involving cocaine, marijuana, and heroin were higher for males than for females. Rates for cocaine were highest among individuals aged 35–44, rates for heroin were highest among individuals aged 21–24, stimulant use was highest among those 25–29, and marijuana use was highest for those aged 18–20.

Feb 21, 2013 - 10:37am
@oii - what about prescription opiods?
Feb 21, 2013 - 10:48am
opiods:

-hydrocodone (alone or in combination) in 104,490 ED visits -oxycodone (alone or in combination) in 175,949 ED visits -methadone in 70,637 ED visits.

Feb 21, 2013 - 11:04am
http://rt.com/usa/fatal-painkiller-overdoses-rise-175/

from that article ".....About 60 percent of the fatalities were due to an overdose of prescription medicines, including addictive painkillers like OxyContin and Vicodin. Such opioid drugs were responsible for three out of four medication overdose deaths, which accounted for 22,134 deaths in 2010.

"Hot-spotting" + "Big Data = Big Picture?

too easy and too much truth?

Feb 21, 2013 - 1:36pm
Your article nails it.
Feb 21, 2013 - 2:25pm
Actually, John2 nailed it and OII buried himself in his own statistics.

OII clearly stated that oxycodone (alone or in combination) [was implicated] in 175,949 ED visits.

So making hydrocodone Schedule II isnt going to change anything because oxycodone and methadone are already Schedule II and contributing to many ED visits.

Again, OII's non-clinical non-opinion is irrelevant and incorrect.

Feb 21, 2013 - 4:42pm
6 thousand % increase in poppy products in Afghanistan since 2001.

Mercs got paid....

Feb 21, 2013 - 7:50pm
OIIIA, if you have learned how to hyperlink since yesterday why don't you offer up an article or two. Its easy to play armchair quarterback without providing your own data for us to examine. Or maybe you just like irritating me. On both counts, pal you fail.
Feb 21, 2013 - 7:51pm
Btw I'm enjoying white wine and a $75 Macanudo tonight while reading your stuff.
Feb 21, 2013 - 11:23pm
OII: You are the only idiot on this whole site hyperlinking stupid youtube videos and juvenille toilet humor, you old kook.

I have already completely dismantled your argument using YOUR data in my 2:25pm post here and you are too dumb to eve realize it. Stupid child.

That's right.....you dont even understand....your own data!! Put that in your pipe and smoke it with your macanudo, whatever that is.

"LMFAO HAHAHAHAH"

Feb 22, 2013 - 10:14am
After writing a 237 page doctoral dissertation 32 years ago I have had the pleasure of having my data "dismantled" on more than one occasion-specifically by a committee of seven MD's and PhD's at the Associate Professor level of higher.

In fact, as graduate students we were trained to dismantle our data as part of the process of learning to think critically about ours and other folks' data. Hence my keen scientific acumen.

Having typed my entire dissertation on an IBM Selectric before the advent of the PC you can appreciate my joy at the ecstacy of hyperlinking.

Actually I don't care if you are comoputer illiterate as you appear to be. So do the following:

1) open up a web page of a scientific article. 2) hit the Print button on your computer. 3( after printing it out, transcribe it into crayola so that you can easily retype it. 4) open up Pharmalot and type in what you have transcribed in crayon.

You see, it's quite easy. You don't have to learn either hyperlinking or copy and pasting.

Feb 22, 2013 - 10:45am
Wow. you managed to completely ignore my email and the facts. Who cares about your dissertation. quantity does not equal quality.

I am pastng this again from my previous email:

Making hydrocodone Schedule II isnt going to change anything because oxycodone and methadone are already Schedule II and contributing to many ED visits.

Read the above paragraph 5-10 times or have a non-senile literate person read it to you.

“LMFAO HAHAHAHAH”

Feb 22, 2013 - 3:37pm
In today's New York Times the International Narcotics Control Board reported that 99% of the world consumption of hydrocodone is in the United States. That's their data, not mine. Doctors in Europe have their share of pain patients but use virtually no hydrocodone. Given this impressive difference I propose not that hydrocodone be upscaled but that we get rid if it altogether.

So I pose this simple question. Since Europe can get along treating pain without hydrocodone why do we need it at all in the United States?

OIIIAI please take your Beano. Your intellectual flatulence is stinking up the Land of Pharmalot. See you later Pedro.

Feb 22, 2013 - 7:07pm
OII: "So I pose this simple question. Since Europe can get along treating pain without hydrocodone why do we need it at all in the United States?"

Isnt the EUMA is the country that gave the OK to acomplia and thalidomide?

You still like Europe? you are welcome to move there anytime. Take Barack Obama with you while you're at it....He's a Europhile too!

annnnnnddd you STILL havent managed to answer the question above

LMFAO, etc.

Feb 22, 2013 - 9:52pm
"Making hydrocodone Schedule II isnt going to change anything because oxycodone and methadone are already Schedule II and contributing to many ED visits."

I thought I answered your question by saying we should get rid of hydrocodone products altogether, then we would not have to worry about whether to or the impacts of re-scheduling it. Or, as Warden Norton said to Andy, "or am I being obtuse".

You don't like Obama. Well here is a little town in Mississippi that I passed through a number of years ago where I accidentally stumbled on a cross burning. Maybe you and your neo Nazi friends can crack a few down there. Now you can go bitch and moan to Ed again about me, you thin skinned POS.

http://en.wikipedia.org/wiki/Hazlehurst,_Mississippi

Feb 23, 2013 - 11:27am
Ah, More brilliance from OII! your "european solution" is to make EVEN LESS options available to pain patients....that pretty much makes YOU the "POS Nazi" to anyone in pain doesn't it?

"LMFAO HAHAHAHAHA"

Had NO IDEA you are a europhile with all their insolvency and stupidity. It actually makes you EVEN MORE revolting and idiotic, and I didnt know that was possible....

Feb 23, 2013 - 11:28am
Keep it up OII. I'm considering changing my name to "OII is a F&*#ing idiot"
Feb 23, 2013 - 12:12pm
@oii - "....In today’s New York Times the International Narcotics Control Board reported that 99% of the world consumption of hydrocodone is in the United States. That’s their data, not mine. Doctors in Europe have their share of pain patients but use virtually no hydrocodone. Given this impressive difference I propose not that hydrocodone be upscaled but that we get rid if it altogether...."

Hmmm, and that 6000% increase in poppy products in Afghanistan since 2001 - ah well, I might just be making stuff up in my "operations" imagination about the connections....

Ethical scientists in USA need to UNIONIZE otherwise hollowood sci-fi is all we'll keep getting from the cult of death - new embalming method worth BILLIONS!:

http://www.huffingtonpost.com/2013/02/21/zombie-cells-sandia-national-labs-university-new-mexico_n_2730166.html?utm_hp_ref=science

Feb 23, 2013 - 8:29pm
OIIIA, you remember that Billy Joel song, "Captain Jack". Made me think of you the line about "Saturday night, couldn't get a date, stayed at home to masturbate". Why don't you go wash your hands so that you can get back to the keyboard and resume your insults. Yes I love European folks. More civilized and don't bitch and moan about their absence of pain. C'est la vie. Hope you got your "PC's for Dummies" by now. I don't make many promises but if we ever meet you will be saying LMFAO with no teeth.
Feb 23, 2013 - 8:35pm
dz, when the troops come home from Afghanistan I hope they bring back enough poppies to make enough heroin so that every worthless junkie can overdose and we can be done with their useless lives. Any left over we can give to the always plaintive patients to shut them and their apologists up for awhile.