OxyContin Being Tested On Kids... So Drugmaker Can Get 6 More Months Of Patent Protection

from the skewed-priorities dept

Thu, Jul 5th 2012 10:20am — Mike Masnick

Want a sense of just how screwed up the incentives of our patent system are today? Purdue Pharma, the makers of the highly addictive painkiller OxyContin, is now running clinical tests to get the FDA to approve its use for kids as young as 6-years-old. Why? Because the Federal Food, Drug, and Cosmetic Act section 505A includes a little "gift": if drugmakers conduct clinical studies for their drugs with kids, they can get six more months of patent protection. So even if they don't even sell OxyContin to six year olds, just securing the extended patent, thanks to the massive monopoly rents given to drugs still on patent, Purdue is likely to profit massively. Lots of people are reasonably troubled by this:

“They are doing (the pediatric trial) for patent exclusivity, there’s no doubt about it in my mind — not out of largesse,” said Dr. Elliot Krane, director of pain management at Lucile Packard Children’s Hospital at Stanford University in Palo Alto, Calif. “That’s important for their bottom line.”

Of course, some will argue that if this provides better drug availability to kids, and those drugs really help the kids, then perhaps this isn't a bad thing. But, no matter what, the incentives here are highly questionable.

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Filed Under: clinical trials, drug patents, fda, oxycontin
Companies: purdue pharma

54 Comments

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Anonymous Coward, 5 Jul 2012 @ 10:26am

and just who is gonna be stupid enough, apart from politicians, to believe that the incentive here is to benefit kids, not improve the bottom line profits? the patent system has been so screwed up by politicians giving extensions to old patents and granting new patents to undeserved pharmas, the only way to mend it is to completely wipe it out and start again, making sure that there isn't a politician in sight when the new rules are decided!
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Lowestofthekeys (profile), 5 Jul 2012 @ 10:30am

I'll be content with events like this when they finally put Vicodin into gummy form.
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Cory of PC (profile), 5 Jul 2012 @ 10:36am

Small Error
Uh, shouldn't there be a "get" between "can" and "six"?
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Josh in CharlotteNC (profile), 5 Jul 2012 @ 10:37am

Young
Get them hooked young.

Works for drugs, cigarettes, politics, and religions.
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Almost Anonymous (profile), 5 Jul 2012 @ 10:41am

On the kids!
It's pharmacy's version of taking a common idea and adding "on the internet" to get a patent approved.

"Oh crap, Viagra is coming off patent protection! What are we going to do?"
"Quick, form up a test group of kids, we'll be able to get six more months!"
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dwg (profile), 5 Jul 2012 @ 10:42am

...
Silly wabbit, Vics are for kids.
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Anonymous Coward, 5 Jul 2012 @ 10:43am

Seems like you're just desperate to find something--anything--that you can use to show that the patent system is the devil. The devil! Give me a break with the alarmist nonsense. The article you linked to says that doctors use the drug off-label regularly. You're not a doctor. You don't have a fucking clue about this drug, other than that it's addictive. So what? Pain medicines tend to be that way. I bet you wouldn't be whining about this drug if your own child was in pain and the doctor wanted to use it off-label. Says you: "the incentives here are highly questionable." Are they? What about your idiotic incentive to spread FUD about all IP law? What about your highly questionable ethics? You love to try and take everyone else apart, but the truth is you yourself can't withstand even moderate scrutiny. That's the reason why you run away from debates with your tail between your legs.
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:Lobo Santo (profile), 5 Jul 2012 @ 10:52am

Re:
7/10

Try not to do the 'wall of text' thing.
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Anonymous Coward, 5 Jul 2012 @ 10:57am

Re:
The patent system IS the devil, it's just really hard for those profiting off it to see from behind all their stacks of money.
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The eejit (profile), 5 Jul 2012 @ 11:01am

Re:
No, the patent system is just FUBAR. You should not be giving addictive drugs to kids unless they are either dying or it is absolutely essential for the treatment. Oxycontin is NOT an essential treatment for children.
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Dionaea (profile), 5 Jul 2012 @ 11:03am

Re: Young
We really need a 'sad but true' button...
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dwg (profile), 5 Jul 2012 @ 11:03am

Re:
Hmm. So, you agree with this drug-maker testing opioids on kids to gain 6 additional months of patent protection? I would like to hear you say exactly that, because that's exactly what's happening.
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Dionaea (profile), 5 Jul 2012 @ 11:05am

Re:
Sadly, doctors quite often don't have a clue what they're doing either.
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Mike Masnick (profile), 5 Jul 2012 @ 11:06am

Re: Small Error
Why yes... fixed. Thanks.
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Karim, 5 Jul 2012 @ 11:08am

Re:
I suppose you didn't read this part:

But three physicians working with Purdue on the trials said the Stamford, Conn.-based company appears to be doing the research to get a six-month extension on their patent for the original formulation of OxyContin, which expires next year.

�They are doing (the pediatric trial) for patent exclusivity, there�s no doubt about it in my mind � not out of largesse,� said Dr. Elliot Krane, director of pain management at Lucile Packard Children�s Hospital at Stanford University in Palo Alto, Calif. �That�s important for their bottom line.�

or this:

�There�s good medical evidence that suggests a brain that�s not fully mature is at greater risk at developing the disease of addiction,� said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing and the head of psychiatry at Maimonides Medical Center in New York City. The pediatric community underestimates those risks, he said, because they have given too much credence to drugmakers, who have systematically downplayed the dangers.

�Much of that misinformation (came from a) campaign funded by Purdue.�

...or any of it for that matter.

Or figure out the math:

$2.8 Billion / 2 = $1.4 Billion

I suppose you think that the physicians and "opioid" experts are just spreading FUD. Do you troll?

p.s. I am not a doctor.
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Karim, 5 Jul 2012 @ 11:09am

Re: Re:
format fail, sorry for this guys!
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Hephaestus (profile), 5 Jul 2012 @ 11:10am

Re: Re:
Ignore him. He is just throwing a hissy fit over ACTA failing in Europe yesterday. Not sure why he is such a dork every other day though.
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Anonymous Coward, 5 Jul 2012 @ 11:13am

>> and just who is gonna be stupid...
>> not improve the bottom line profits?
No one that matters is going to care.
It's a legal loophole in the system, and as long as the right palms are greased and beaks wetted, it's going to continue.
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Karim, 5 Jul 2012 @ 11:16am

Re: Re: Re:
Right. I should have realised that the artifacts would be "extra-trolly" today in the wake of having their asses handed to them (and by democratic due-process, for a change).
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Anonymous Coward, 5 Jul 2012 @ 11:17am

Re: On the kids!
Hey, it might help get them up in the morning...
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Mason Wheeler, 5 Jul 2012 @ 11:19am

Re: Re:
Sad but true. I used to work at a rehab center, and you would not believe the number of clients who got started that way. Not everyone fits the "junkie profile"; there are a large percentage who got prescribed something way too strong by a clueless doctor or dentist, then kept on it way too long, and then when the doc realized the patient was addicted to pain pills, he cut them off, cold turkey, with no resources or help to manage their addictions.

That happens more than you'd think, and Purdue isn't even the worst of it. Fun fact: patent or no patent, Mallinckrodt also makes a generic form of OxyContin. But Mallinckrodt is also the company that makes Methadone, which is what you use to treat opioid addiction. So they profit on it both ways!

Gotta agree, though. Testing OxyContin on kids is a crime against humanity, on par with just about anything Monsanto's done. St. Paul had it right when he wrote that the love of money is the root of all evil.
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Richard Weed, 5 Jul 2012 @ 11:26am

Didn't Sandusky go to jail for doing this to kids?
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Fanic, 5 Jul 2012 @ 11:39am

Re: Re: Young
I agree. To many times I have wanted to use one.
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SAG, 5 Jul 2012 @ 11:41am

Re: Re:
I couldn't agree more and have seen how destructive this type of medication can be in adults - I shiver to think how it would effect children...
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Digitalistically Speaking (profile), 5 Jul 2012 @ 11:43am

This is your kid on Drugs
What kind of parents sign their kids up for trials on addictive drugs?

I would much rather they allow them to use marijuana for pain control.
The manufactures of this little miracle weed don't need patent protections,are not afraid of the competition
and don't seem to worry about their bottom line.
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PJ, 5 Jul 2012 @ 11:44am

I have to say that this doesn't seem like the big deal it's made out to be... Isn't this the whole point of the Sec 505A? It provides a profit incentive to fund safety and effectiveness studies with children--studies that tend not to get done since children don't tend to be nearly as profitable as adults, for statistical reasons if nothing else. As to whether the the benefits of research with children outweigh the costs of delaying ANDA submission/generic drug production, that's an important question, but without some hard data, it seems reasonable to assume it's basically a wash.

And as for everyone getting bent out of shape over the particular drug, that's ridiculous. Doctors can and DO prescribe narcotic pain killers to children, including OxyContin. If the child is in excruciating pain, it would be terribly cruel not to. And they do it WITHOUT studies exploring the optimal dosage, timing, and side-effects. The whole point is to determine out with limited, carefully observed testing what those are. No doubt that opioid painkillers, particularly ones like OxyContin, ought to have a higher threshold of "need" for children than adults, but without exploring the effects, how are we to know what that is?
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The eejit (profile), 5 Jul 2012 @ 11:45am

Re:
Only with added steroidal abuse! Which makes it BADWRONGFUN!

/s
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Anonymous Coward, 5 Jul 2012 @ 11:47am

Re:
You're not a doctor. You don't have a fucking clue about this drug, other than that it's addictive. So what? Pain medicines tend to be that way.

Medical Marijuana is a pain medicine and it's not physically addictive, so you're wrong. Go on, admit it. You are wrong.

Go on . . . you can do it . . . thought not.
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Berenerd (profile), 5 Jul 2012 @ 12:06pm

Re: This is your kid on Drugs
ones needing money for their crack fix...
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Anonymous Coward, 5 Jul 2012 @ 12:11pm

Re:
Why do it so late in a patented drugs lifespan? It has been used offlabel for children so far. Why not just leave it as is? I would say that patent-lenght should not be the determining factor. There are plenty of other ways to give an incentive. Holding the price on newer medicine high for a longer period does not seem like the advantage to society you want from a patent. That is the primary reasoning.

secondly: Opioids! They include some real nasties. In general it is not something any doctor should use on children if they can avoid it. Getting an opioid approved for children is a slippery slope.
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Anonymous Coward, 5 Jul 2012 @ 12:14pm

Re:
please tell us how a child will be able to fully understand the effects happening to their bodies

and then accurately explain those effects to their physician

and then that physician accurately understanding what that child is telling them

..and to begin conducting these experiments a year before the patent expires. how long has oxy been used for pain management?

this is fubar'd
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SAG, 5 Jul 2012 @ 12:16pm

Re:
I don't need a study to know that kids getting hit by a bus is a bad thing and that's what opiates are - a bus accident looking for a place to happen. Also note that actual pain levels for kids are at a much lower threshold than for adults.

Given this and the further fact that PAIN is an essential feedback to let you know that something isn't right or needs further healing is problematic as children are not developed sufficiently to make proper decisions about what should and should not be masked. Opiates mask that pain and can lead to excessive overuse of whatever is damaged which leads to longer recovery times and/or further damage.
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Anonymous Coward, 5 Jul 2012 @ 12:48pm

Let's get more people hooked on Oxy so I can have even more people break into my car looking for things to steal to support their habit. Great!
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Anonymous Coward, 5 Jul 2012 @ 1:04pm

Maybe not so funny
It already disturbs me that vitamins (whose positive effects are at least arguable) comes in gummies, even for ADULTS. Can it be good for a four-year-old to find a bottle of "VitaFusion" and gobble down 150 of 'em...?

And don't tell me about "child proof packaging", please...
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BeaverJuicer (profile), 5 Jul 2012 @ 1:35pm

This may actually be a case of the patent system working for the betterment of society... But not because of the profits to pharma.

Everyone seems to be aware of the highly addictive nature of Oxy. Keeping the patent extended, for even 6 months, will keep the generics from manufacturing it, thus keeping it a little harder to get your hands on.

Once the Generics start making Oxy too, well, availability goes up, and street price goes down.

Again, in this one instance, I would support extending the patent for the betterment of society.

Now, can someone please make some Children's Chewable Barbiturates in cheap gummy form so I can stop paying the babysitter?
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Mason Wheeler, 5 Jul 2012 @ 1:56pm

Re:
Not sure exactly how it works in light of the patent, but there's already a generic oxycodone available, from a company called Mallinckrodt. They're also the ones who make Methadone, which is what you use to treat opioid addiction. So they profit on both sides of the issue. Lovely, no?
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DannyB (profile), 5 Jul 2012 @ 2:07pm

Re:
For fun, try googling for: children's chewable valium
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DannyB (profile), 5 Jul 2012 @ 2:10pm

Re: Re:
I believe the difference is that oxycodone is not time release.
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AzureSky (profile), 5 Jul 2012 @ 4:22pm

Re: Maybe not so funny
a few studies I have seen show how "child proof" really means "adult proof"

hell, years back when they started making those child proof lighters.....a woman I worked with couldnt get her lighter working, her 7yo daughter use to light her smokes for her....

thankfully she quit smoking eventually because I really think it was teaching her daughter a bad lesson about smoking.
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Teresa (profile), 5 Jul 2012 @ 4:56pm

Re: Re:
What neither of these 2 stories said, was that its a small test of 157 children in the US, ages 6-17, who are already opioid-tolerant, and are experiencing extreme pain from cancer, post-operative pain, and severe burns.

http://thechart.blogs.cnn.com/2012/07/03/pharma-company-studying-oxycontins-effect-in-chil dren/

If your child had severe burns, and you had the choice of giving them Oxycontin to remove the pain entirely, or giving them lesser pain meds and them still being in pain, what would you choose?

Now, I'm not saying Purdue is doing this out of the goodness of their hearts (more like to increase their wallets), but its not a bad thing that they're doing this testing.
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G Thompson (profile), 5 Jul 2012 @ 8:27pm

Re: Re:
Methadone DOES NOT TREAT opioid addiction, it replaces it with another addiction and one that is sometimes worse then the original since methadone is legal, able to be gotten for nothing (the state pays normally), and ubiquitous.
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Anonymous Coward, 6 Jul 2012 @ 8:14am

OUTRAGEOUS!
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Wally (profile), 6 Jul 2012 @ 8:20am

Screw the patent and copyright
Fuck the copyright and patent problems and shit involving politics involved. This is a very very serious breech in ethics and I hope the company involved gets their liscense pulled. Animals and critters are one thing, but FUCKING HUMAN TESTING Oxytocin ON CHILDREN is drawling the line. I hope people haven't squabbled about the politics and patent debates on this. Yes, human test trials are fine, but Oxytocin is not your average medication to use on a child. Things like that make me foam at the mouth and I hope to God that you all understand why.
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Wally (profile), 6 Jul 2012 @ 8:27am

Re: Re: Re:Methadone
Your statement on how it is just replacing another addiction to treat the addiction... Just to back your statement, I would like to remind everyone of how Anna Nichole Smith died. Overdose of Methadone.
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Anonymous Coward, 6 Jul 2012 @ 3:51pm

Re: Re:
What's the difference between medical marijuana and just plain old marijuana?
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Anonymous Coward, 6 Jul 2012 @ 3:54pm

Ten years from now, expect to see a dramatic rise in school shootings and youth homicides and suicides.
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Dadam, 6 Jul 2012 @ 11:03pm

In response to some of the more hysterical comments here, I want to point out that there are real children whose pain can only be managed by opiate pain killers. My 11 year old son has to use Oxy-contin as breakthrough pain meds for acute neuropathic pain.
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bb RN, 8 Jul 2012 @ 5:03pm

Has anyone noticed the shock value in this article? It starts with the first sentence: "the highly addictive painkiller OxyContin..."

Is OxyContin addictive? Yes. However, addiction starts when the drug is being abused. There's a difference between addiction and TOLERANCE, which occurs when a body gets used to having the drug, so it needs more for it to become effective.

Does anyone really think a 10-year-old will start snorting their OxyContin to get high? Hopefully, if in the correct household, they won't. You don't become addicted if you take your medication in the way it's prescribed.

I'm a nurse on a surgical floor, where we hand out narcotic pain killers all the time, by the way, so I know what I'm talking about.

I don't really see the problem with testing it on kids. See how they do with it. In certain cases, it would be absolutely appropriate to prescribe.
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bb RN, 8 Jul 2012 @ 5:05pm

Re: Re: Re:
That's correct, oxycodone is "immediate release" and OxyContin is time release.
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patent litigation, 9 Jul 2012 @ 5:35pm

sorry
Sorry, but I really don't think 6-year-olds should be taking OxyContin, and certainly not for the sake of extending patent protection for big pharma. This is a screwed-up incentive structure.
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satvairic, 1 Jun 2013 @ 4:01pm

Re: tech
the robberies wernt an epidenic til they pulled the genrics off the market for te last time in 2010 then pharmacy robberies went thru the roof knowing this new omula meant the end of the old formula than buying herion on the streets wich made a huge huge come back thanks to ourdu wich that drug is not regulatted to how much or it was cut with atleast with the o=pharma OC,s people felt safer and knew how much they were doing butdint know not to take with Alcohol number one then any type of CNS drug and Now there saying over 8 onces of Grapefruit can make yaD on oxy and 85 other drug it about anything Man made is whats dangerous,,the deadly side effects commecials for drugs on TV followed by the lawer commercials if you know some one who has taken that drug call rite away cuz its killing people and yuo may get sum money is how fast the lawer watch dogs are keeping up with the darkside of pills and cures..
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satvairic, 1 Jun 2013 @ 5:16pm

Re: Re: tech
the worst thing was hearing the lies on the OC,s Purdues reporst of course showing 15,00 the first time from 08-2011 when in fact 2011 ther were 2.5 million deaths related to alcohol related deaths just last year alone and a world report was recenctly done and aclcohol came out to be the worst drug in the world by ordinary polls done by a world group and they also Approvved a new formula that has bitrate bindwes in it they use in motercycle oil,Diesel ect go to whycpidia look up oxycodone and they will give ya the skinny on the Doctor who invented Oxycodone and years but alittle personal insite why he wanted to invent thisype of drug that was qway ahead of its time til our coverment made the mistake by lett,ing big pharmas get into our govs pocket thru Medicare and state ta state medicaid that wont pay for purdues oxname brand cuz they know its an in side sham and has ben for years,there just now trying to crack down on paying little pharmas from hitting the market neting them 10 million more if they were to produce the generic and make only 2 million!! thatis a sham and illigal and keeping the real patients that can handle it and not the kids stealing them fom paople kids are gonna try anything ti get High if there after that thru peer pressure or what ever ect.. but the gov ben blind eyeing it cuz theve ben in on the Cia help,n to bring in the loads of drugs and flip,n the money to keep that worthless war on drugs,,Obama himself the war freagan started was an Utter Failure on the war on Drugs Quote!!
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satvairic, 1 Jun 2013 @ 5:19pm

Re: Re:
Rite On,,, LOL
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satvairic, 1 Jun 2013 @ 5:36pm

Re: Screw the patent and copyright
Im with ya and when it comes to Foam,n at the Mouth I think you can see Behind there gaame from Both sides and are Crooked just like the crack dealer on the streets the FDA is just the street pawn but the real drug deals are going thru the whitehouse,,they ban Oxy old Formula but Endo trys ta sue too and loses so there is old formula Opand out there rite Now that is even Higher in addiction since no genrics of a regulated addition than dirty street Smck thats about to sTART TO HAPPEN ALL OVER! Cuz of oxy genrics the herion went so cheap and they were made by there bosses to make it stronger to compete with the legal drug dealers and its ben working in Folds rehabs and counslers want you to see any kind of drug bad and treat it if it ment there jobs!! ya think!!they were automaticly on the no genrics is there any genric Herion thtas safe to take as needed Like the prime minister in canada said to all yhe poltical partys tells a science test whats safe and not safe to take as recommended and Canadams sciencetist did just that looked at the drug it self and testsed and for it to be safe to take ass needed and recomended so it was Passed with out a blink of an eye with all that Political Power pressure Hanging on her shoulders she followed what rite,and also said what the untied states is about to face by letting political powere pulling the strings!! and its happenning just pay mind to certain things and you too will see thru the gov bullshit even if ya never took or had to take any of these pain meds,,
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