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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: Sally'sConcerns
You very well MAY be a "drug abuser",since for some reason or other,you've chosen to take umbrage with my posts.Only YOU are taking what I said personally.

There are many people on FR,who live in constant pain due one thing or another.Most of them don't post to the pro-doper threads,demanding that all now illegal substances be made legal and wanting the WoD done away with.

You sound as though you could benefit from learning pain management classes,a set of new doctors,and perhaps some psychoanalysis. No,I'm not a doctor,I don't play one on T.V.,but you're far too angry over an internet thread. Oh,and as far as your migraines go,you should avail yourself of a headache clinic (The Diamond Headache Clinic,in Ill. is really very good!),so that you can get off sedatives.Cluster headaches are worse than migraines(and yes,I know EXACTLY how horrendous a migraines is,having suffered from them almost my entire life!),but sedatives are NOT given for them.

You may not realize it,but you just admitted to the fact that you REALLY want the high,want it more than to be free of the pain.Yeah...that makes you someone who isn't interested in just alleviating the pain.

241 posted on 04/25/2004 4:53:00 PM PDT by nopardons
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To: nopardons
I'm not taking what you said personally. It makes me no difference what some anonymous poster to an internet board says about people who are in chronic pain. Sweetie, you have no impact on my life whatsoever other than I was motivated to respond to you.

I wasn't aware this thread was a pro-doper thread. My mistake since I didn't see it in the title or in the keywords. I was under the mistaken impression it was about new and improved pain medication being developed.

As far as pain management, I've been to four separate pain management Doctors (all under the same primary care physician so I wasn't doctor shopping) and am currently under the care of another one. I had to change since I moved from Texas to Oklahoma. The migraines are caused by a botched 3 level cervical fusion. Before you make a sweeping generalization about what sedatives are prescribed for, you might review what Fiorinal (which contains a sedative) is prescribed for.

Nowhere did I admit I wanted the high more than I want adequate pain relief. Please take a moment to re-read my posts. I find it amazing how you can know what's in my mind by a couple of posts on an internet board.

I also would like to have you provide proof I ever said anything about illegal substances being make legal and the WOD being done away with. I think if you review my posting history you'll find I don't participate in the "to drug or not to drug" threads. Please have the courtesy to desist in putting words I never said into my mouth.
242 posted on 04/25/2004 5:10:42 PM PDT by Sally'sConcerns (It's painless to be a monthly donor!)
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To: Sally'sConcerns
Boy are YOU in denial!

You are correct about what this thread started out as,but,as usual,it was taken over by the pro-dopers.And you've added to their shrill cry.

As a life long migraine sufferer,I know full well what has been and is now prescribed for them.You're the one who said that you're taking a "sedative" for the migraines you get.You also posted to a public forum,that you NEED/enjoy the "HIGH",which lasts 30 minutes.If you don't want your own words to be used,as part of a refutation, then either think carefully before you post,or don't post.

I wrote about what FR's permanent group of pro-dopers post to threads..re their anathematic,knee-jerk,reflexive reactions and words.If they don't fit you,then you need to post more cogent replies.Elsewise,you'll be associated with that group.

You're still reacting as though you are the ONLY person,who suffers from debilitating pain.Yu aren't. A migraine is a migraine is a migraine, no matter why one has them.You've only suffered through them since 1994.I'm quite a number of decades ahead of you.You were an adult,when they first hit you;I was six years old.There is actually quite a largish group,on FR, who have migraines,due to operations such as the botched one,that set off your headaches,as well as others,such as myself,who get them for other,non-opperation related reasons.

Go read your own posts.I didn't embellish what's in any of them.

243 posted on 04/25/2004 8:05:38 PM PDT by nopardons
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To: nopardons
Reading your post reminded me of the 'good ole days' of suffering from cluster headaches.
244 posted on 04/25/2004 8:17:35 PM PDT by cyborg
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To: nopardons
Your interpretation:

You also posted to a public forum,that you NEED/enjoy the "HIGH",which lasts 30 minutes

My words:

The short time I experience the 'high' from the drugs is welcome relief as I get somewhat floaty and don't care nearly as much about the pain

You would take away a short period of time where I relax, get floaty and forget for a short time about pain

I don't see the words need or enjoy.

What are you so angry about? Why do you feel the need to put words in someone's mouth that they never said? The only one associating me with "that group" is you. Where did I say I thought I was the only person suffering from chronic pain?

Do you have a migraine now? Is that what is impairing your ability to read what I've said?

Life is too short and too precious to listen to you screech about what you think I've said. I hope you feel better soon. As for me, I'm going to toddle off to bed and enjoy the sound of the rain as I fall to sleep.

Good night and sweet dreams.

245 posted on 04/25/2004 8:27:22 PM PDT by Sally'sConcerns (It's painless to be a monthly donor!)
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To: Sally'sConcerns
you might review what Fiorinal (which contains a sedative) is prescribed for.

.Several years ago I was given this med for really bad headaches. Nothing stopped them from recurring, and one day I read something about tests finding that Fiorinal sometimes actually caused recurring headaches. I decided to try stopping the meds and the headaches did stop. Might just be a certain people thing, but it really did stop mine and I am headache free these days.

246 posted on 04/25/2004 8:33:28 PM PDT by ladyinred (Kerry has more flip flops than Waikiki Beach)
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To: nopardons
There are many people on FR,who live in constant pain due one thing or another.Most of them don't post to the pro-doper threads,demanding that all now illegal substances be made legal and wanting the WoD done away with.

.Amen my friend!

247 posted on 04/25/2004 8:44:04 PM PDT by ladyinred (Kerry has more flip flops than Waikiki Beach)
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To: Sally'sConcerns
You bet I'd take away your "floaty" time.Why isn't the relief from pain enough?Could it be because you ENJOY the high and the release from pain is just not as important to you? That's what it sounds like!

I'm not "angry", but you are and defensive to boot.Now just WHY is that? Because you like getting HIGH,but have the "out",in your mind, because it's "for the pain"?

I don't need to get all " floaty"...I just NEED the pain and the attendant,debilitating symptoms to go away.:-)

No,I don't have a migraine now,do you..or are you just so over medicated that you have no idea what your posts read like,nor anyone else's,for that matter?

If "life's so short",then I suggest that you shouldn't have started posting to me,but having done so,stop.After all,you just might get a worse headache doing so;not to mention apoplexy.;^)

248 posted on 04/25/2004 8:52:28 PM PDT by nopardons
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To: Jorge
Yes. When I was given hydrocodone for my back pain, I noticed it helped my depression as well. However, the SSRI's I was prescribed came with various unwanted side effects, and a few of the SSRI's I tried made me feel downright strange, so I discontinued their use. I have read that it is not clearly understood how these psychoactive drugs act on the brain, and many act to disable brain activity and long-term use can result in people acting as zombies as you've described having been given a chemical lobotomy. I see them mainly as a huge revenue generator for the pharmaceutical companies and the pill-pushers who prescribe them.
249 posted on 04/26/2004 11:44:56 PM PDT by gawatchman
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