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Drug Makers Hope to Kill the Kick in Pain Relief
NY Times ^ | April 20, 2004 | SANDRA BLAKESLEE

Posted on 04/23/2004 4:22:42 PM PDT by neverdem

Worried that millions of Americans are using prescription opiate painkillers to get high rather than to ease severe chronic pain, drug makers are working on ways to prevent abuse.

Cooperating closely with government officials and pain specialists, the companies are educating doctors, rewriting warning labels and tracking pills as they move from pharmacy to patient.

They are also reformulating pills with added ingredients. One combination blocks euphoria. Another produces a nasty burning sensation.

"The problem of prescription painkiller abuse is much bigger than people realize," said Dr. Clifford Woolf, director of the neural plasticity group and professor of anesthesia research at Massachusetts General Hospital in Boston and Harvard Medical School.

"No other drug type in the last 20 years had been so abused in such a short period of time," he said. "It's an epidemic."

According to the Substance Abuse and Mental Health Services Administration, more Americans abuse prescription opiates than cocaine and the abusers far outnumber those who misuse tranquilizers, stimulants, hallucinogens, heroin, inhalants or sedatives. After marijuana, pain pills are the drug of choice for America's teenagers and young adults.

How modern painkillers came to be abused is a story of good intentions gone awry. The painkilling action of the opium poppy has been known for thousands of years. Misuse of painkillers also has a long history. A century ago, mothers routinely rubbed tincture of opium on the gums of teething babies to soothe the pain, then took a nip for themselves.

If the medicine was not locked up, other family members often helped themselves. Indeed, the problem got so bad that makers of paregoric, the most popular liquid opiate, added camphor to their formulations to set off a gag reflex.

In recent decades, doctors stopped prescribing opiates because 5 to 10 percent of people who took them became addicted.

Fear of addiction led to the undertreatment of pain and to untold suffering, said Dr. Russ Portenoy, chairman of the department of pain medicine and palliative care at Beth Israel Medical Center in New York.

The 50 million Americans with chronic pain needed help. It arrived five or six years ago when pharmaceutical companies put very large doses of opiates into slow-release formulations. A person who swallows such a pill feels no euphoria but is relieved of pain for up to 24 hours.

The new painkillers were heavily marketed to primary care physicians, Dr. Portenoy said. It was thought that the drugs would not be abused because addicts would not be tempted by sustained release painkillers.

Unfortunately, addicts quickly found that they could grind the pills, swallow or snort the powder and get a high dose of opiates delivered directly into their bloodstreams. They also liked the fact that the drugs were pure and the exact dosage was known.

To counter abuse, drug makers are developing ways to reformulate prescription painkillers. Purdue Pharma in Stamford, Conn., which makes OxyContin, is thinking of adding a second drug, called an opiate antagonist, that neutralizes the effects of the opiate.

The antagonist would be walled off using polymers or some other sequestering technique, said Dr. David Haddox, the company's vice president of health policy.

A patient who swallowed the drug would get full pain relief, as intended. But if someone tampered with the pills, the antagonist would be released.

Then, Dr. Haddox said, one of two things would happen: "If you are a recreational drug user, you feel nothing. The effect is canceled out.

"Why abuse something that has the same effects as a glass of water?"

"But if you are physically dependent," he continued, "you get no euphoria and it might cause withdrawal. You'd get a double whammy."

A second approach is to mix in a chemical irritant like capsaicin, the main ingredient of hot chili peppers, said Dr. Woolf, who has a patent on the idea.

Because the esophagus and stomach do not have many receptors for hot peppers, patients could take the pills as prescribed and find relief, he said. But the lining of the nose and cheeks are loaded with pepper receptors, and anyone who ground up such a pill would get a burning feeling in the chest, face, rectum and extremities, as well as paroxysmal coughing.

Reformulations are a promising avenue, but there are risks.

"We want to make sure that a patient who has need of an opioid does not suffer side effects from a second drug for which he or she has no need," Dr. Haddox said.

"We need to make sure the antagonist doesn't leak," he added.

Approaching the problem from another direction, drug companies and the federal authorities are trying to educate doctors and crack down on doctors who, for whatever reason, dispense painkillers inappropriately.

The Food and Drug Administration, Dr. Portenoy said, is going after doctors who are "duped, dishonest, disabled or dated."

For example, the agency is relabeling prescription painkillers to warn primary physicians of the risks involved. Some doctors, he said, are using the new drugs for broken fingers rather than devastating chronic pain.

New labels are also being introduced to tell doctors how to recognize patients who may be prone to abuse — those with a personal or family history of alcohol or prior drug abuse or mental health problems like bipolar disease, for example — and if the doctor is suspicious, how to monitor those patients with urine tests or other methods.

Some patients go doctor shopping, obtaining prescriptions from a dozen or more family physicians. Others tamper with prescriptions. To address this, drug manufacturers are providing doctors with tamperproof prescription pads that make forgeries difficult. When a prescription is photocopied, the copies say "void."

Doctors are also being taught how to write prescriptions more carefully. Instead of writing 14 pills, which a patient could alter to 140, the doctor writes out the word fourteen. Doctors are also being urged to lock up their prescription pads in the same way they would personal checks.

The Drug Enforcement Administration registers all people who handle opiates, inspects the documentation of opiate distribution, controls imports and exports and oversees the amount of the drugs produced, bought, sold or otherwise transferred. Yet, despite these controls, large amounts of prescription painkillers are being stolen once the drugs move into the hands of pharmacies, doctors and patients. Armed robberies, night break-ins and employee thefts are common.

In the face of so much criminal activity, the drug agency is stepping up efforts to prosecute dishonest pharmacists and doctors who sell opiates for personal profit and to use computer search programs and other means to close down so-called pill mills on the Internet. Electronic prescription monitoring systems are being enlisted. If the same prescription goes to 15 pharmacies, the computer system will sound an alarm.

Still, drug addicts will continue to find ways to foil the efforts to foil them.

People who came to like paregoric learned to boil the liquid, which removed all traces of camphor. The dregs were pure tincture of opium.


TOPICS: Business/Economy; Crime/Corruption; Culture/Society; Extended News; Government; News/Current Events; US: District of Columbia; US: Massachusetts; US: New York
KEYWORDS: capsaicin; chronicpain; dea; opiateabuse; opiateantagonist; opiatedependence; opiates; wod
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To: JDoutrider
BTW, I've been on that scale. I know for DAMN sure it isn't the number of pain, but the trend and relative movement of it.

an 8 or 9 means nothing. You take that number, and see how it changes versus treatment.

You should know that, being a medical expert and all.

What's the name of the scale again? I want a good laugh.
141 posted on 04/24/2004 12:13:34 AM PDT by Monty22
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To: JDoutrider
Just so you know, the Mankoski Pain Scale means nothing in absolute terms. It's a lot like the polygraph. A make believe scale that is used to measure change. You can go from 2 to 5 and it's seen as bad.

People have different levels of pain levels. You should know this. I'm surprised you'd insult me, while mispelling the name, and not even knowing what it really is all about.
142 posted on 04/24/2004 12:20:26 AM PDT by Monty22
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To: Monty22
Sir Monty:

It matters not who you bow down to when you are mistaken...

It DOES matter when your ignorance is mistakenly posted as truth.

I DO wholeheartedly believe you need to get yourself informed about the arena of analgesics!

What you have posted here is positively uninformed and biased. We in the medical profession, consider what your arguments against analgesics are neanderthal.

The AMA, JAMA. et cetera wholly condemn your thesis...what medical college are you graduated from?

Inquiring minds need to know.

143 posted on 04/24/2004 12:24:43 AM PDT by JDoutrider
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To: JDoutrider
Where are you graduated from?
144 posted on 04/24/2004 12:26:12 AM PDT by Monty22
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To: Monty22; JDoutrider
Monty22: "an 8 or 9 means nothing."

Mankoski Pain Scale
Copyright © 1995, 1996, 1997 Andrea Mankoski. All rights reserved.
Right to copy with attribution freely granted.

8

Physical activity severely limited. You can read and converse with effort. Nausea and dizziness set in as factors of pain. Stronger painkillers are minimally effective. Strongest painkillers reduce pain for 3-4 hours.

9

Unable to speak. Crying out or moaning uncontrollably - near delirium. Strongest painkillers are only partially effective.

145 posted on 04/24/2004 12:27:22 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: Monty22
To start, as in..

As in.. you're stuck for a way out of your position?

Why do I bother.

It beats being honest and admiting that you recommended "SSRI's at the time of trauma to start"? (post #110)

146 posted on 04/24/2004 12:27:36 AM PDT by Ken H
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To: AntiGuv
Those numbers mean nothing. I can go in with a headache and say I'm a 6, take an aspirin, and say it's a 7 after.

It's a COMPLTELY SUBJECTIVE RATING

The only thing doctors look for is the change, up or down. Then they know the effect (more or less) of the medication!

147 posted on 04/24/2004 12:29:29 AM PDT by Monty22
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To: Ken H
Again, I said SSRI's to start from then if needed. IF the emotional trauma may need it.
148 posted on 04/24/2004 12:30:13 AM PDT by Monty22
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To: AntiGuv
In response... An 8 or 9 means EVERYTHING...sorry for the mistatement...
149 posted on 04/24/2004 12:32:42 AM PDT by JDoutrider
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To: Monty22
Just as an idle aside, in order to know the effect of the medication, one must first prescribe the medication without yet knowing the effect of the medication..

BTW, your statement was definitely false on its face, please don't compound the spectacle by persisting in your falsehood.
150 posted on 04/24/2004 12:32:58 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: AntiGuv
Also, this is not a common use scale.. note:
Results 1 - 10 of about 125 for Mankoski Pain Scale

that's it. She made it up.

The 1-10 scale is a simple relative scale. It is commonly used.

Your paste of a personal website, is embarrassing to you.

It's not a standard. The real pain scale of 1-10 is a purely relative scale.
151 posted on 04/24/2004 12:34:27 AM PDT by Monty22
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To: JDoutrider
Nobody uses that scale, or that name for it. It's a one-off personal use site.

152 posted on 04/24/2004 12:36:23 AM PDT by Monty22
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To: AntiGuv
Again, as I've researched, one person came up with this and you found their site.

And this is your reply? Pitiful!
153 posted on 04/24/2004 12:38:44 AM PDT by Monty22
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To: Monty22
hehehe.. It must suck to be you in this thread. You're really getting gangbanged from all sides. I'm surprised your fellow drug warriors haven't swooped in to your defense.

Perhaps you should stop while you're behind, go to bed, and decide whether it's worth coming back in the morning.

PS. You're starting to whine in some of your posts. It's very unbecoming..
154 posted on 04/24/2004 12:40:33 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: AntiGuv
You quoted this as your source:

andi@valis.com

www.valis.com/andi
393 Anna Avenue
Mountain View, CA 94043

I am a human computer interface designer, which means I do industrial design for computer software. I design the parts of programs that people interact with. My job is to make software useful, easy to use, aesthetically pleasing, and if possible, fun.
I work at Sun Microsystems in the Software Products and Platforms division.
155 posted on 04/24/2004 12:42:12 AM PDT by Monty22
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To: Monty22
LOL! I personally don't give a damn about the scale. Scale or no scale it doesn't reduce the cluelessness of your comments. I admit, my only goal was to prove you wrong. I succeeded.. =)
156 posted on 04/24/2004 12:42:34 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: AntiGuv
As I note, your 145 quoted this person.. And so did someone else who 'attacked me'.

LOL.


No whining, but I'm shocked you guys are reaching so low.
157 posted on 04/24/2004 12:43:23 AM PDT by Monty22
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To: Monty22
Again, I said SSRI's to start from then if needed. IF the emotional trauma may need it.

Yes, I know you said SSRI's to start, and I assumed you would continue them if needed. Thank you!

Now, where do you get that SSRI's are to be used "at the start of trauma" when the Merck Manual says this:

"Drugs to assist sleep may help, but other drugs are probably not indicated because they may interfere with the natural healing process."

http://www.merck.com/mrkshared/mmanual/section15/chapter187/187f.jsp

158 posted on 04/24/2004 12:44:17 AM PDT by Ken H
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To: AntiGuv
You failed, you tried to use some nonsense against me, and I proved how silly you were :)

You failed, badly.

So far people on this thread:

1: someone jordge to me that docs won't prescribe anti-depressants and opiates.

WRONG

2: something about some computer science major's pain scale

SILLY

Sorry, you druggies lost bad.
159 posted on 04/24/2004 12:45:21 AM PDT by Monty22
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To: AntiGuv
Actually, it stinks to be you pro-dopers.Few people here even bother with these threads,because you play "dog-pile on the rabbit",with the antis that show up.Most people do NOT agree with you and your kind.But then, you already knew that.:-)
160 posted on 04/24/2004 12:46:27 AM PDT by nopardons
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