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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: Monty22
"Celebrex and Ultram are great..."

Ultram was originally marketed as a nonaddictive, non-opiad pain reliever. However, it along with it's generic twin Tramadol has turned into a real addictive monster.
Take a few moments to do a Google/Yahoo search for Tramadol, or Ultram addiction. I think you will see a much different picture than you described.
221 posted on 04/24/2004 5:17:42 AM PDT by devane617
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To: Monty22
Drugs are not protected by an amendments.

What protects your right to breath? You right to marry, or not? Or, maybe you have it backwards: Does the Constitution (a) enumerate our rights, or does it (b) enumerate the powers of government?

Now go back to the Prohibition amendment question.

222 posted on 04/24/2004 5:45:35 AM PDT by eno_ (Freedom Lite - it's almost worth defending)
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To: Monty22
Define 'teatotal' please.

Do you abstain from consuming psychoactive substances? We are way into "meaning of "is" territory here. What's so hard about "teatotal?"

223 posted on 04/24/2004 5:49:00 AM PDT by eno_ (Freedom Lite - it's almost worth defending)
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To: Jorge
Horse hockey. It stimulates opiate receptors, but is an opiate antagonist also. Ask an opiate addict.
224 posted on 04/24/2004 3:02:39 PM PDT by jammer
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To: jmc813
I NEVER voted even once,for Clinton.Did you?
225 posted on 04/24/2004 6:07:42 PM PDT by nopardons
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To: Monty22
If we're going to be honest, as I was with my anti-depressant/pain killer treatment (which you said 'NO' doctor would do!(LOL)) why don't you answer my questions about what your current illness is.

Firstly, I was talking about the more common anti-depressants like Welbutrin and the opiate pain killers. One is a stimulant, the other is a depressant and no reputable doctor would prescribe both at once. Unless he's a quack.

It seems that there are other anti-depressant/pain killer treatments that would not cause drug interactions as you and some other posters have pointed out. I'll take your word for it.

And as far as what my "condition" is, I have a terminal illness which I rarely discuss in online forums anymore, because it only lead to problems in the past online.

But I can assure you I am doing well for now, am still working full time and am very thankful to God for that!

226 posted on 04/24/2004 10:52:48 PM PDT by Jorge
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To: gawatchman
I think that narcotics are a little too controlled, and could actually be dispensed to treat depression as well as pain as long as they are not abused. They help elevate someone's mood, and can make them more responsive to other forms of treatment, and in moderation are less dangerous than alchohol.

I agree 100%.

As someone who used to be depressed to the point of being suicidal in my late teens and early 20's(and attempting it more than once) I found that certain narcotics were very helpful psychologically.

I'm not talking about getting high every night to numb the pain of being depressed.
I'm talking about short term use of narcotics to break the patterns of negative thinking that keeps people trapped in depression day after day, week after week, often for years on end.

I know this from experience. I would get stuck in ruts of depression that I couldn't seem to get out of no matter how I tried. I would become so negative as to drive everybody away who wanted to help and would become physically ill, on top of it repeatedly.

However, I discovered that certain drugs, especially narcotic pain killers would as you said, elevate my mood. And not only that, they would break the self-feeding pattern of negative thinking, which would free me from the depression.
AND NOT JUST when I was taking the narcotics, but even long after I would stop taking them.

There is also a growing body of evidence that SSRI's actually induce mental illness in the long term, and are actually quite dangerous.

Yes they are. And the idea that person has to keep taking them EVERYDAY is no good, not only physically but mentally.

I think they make people into zombies.

227 posted on 04/24/2004 11:29:33 PM PDT by Jorge
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To: jammer
Horse hockey. It stimulates opiate receptors, but is an opiate antagonist also. Ask an opiate addict.

Whatever. The fact is Ultram is classified as a synthetic opiate. Look it up.

228 posted on 04/24/2004 11:31:50 PM PDT by Jorge
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To: eno_
Words and phrases have set meanings.You just made up your own meaning,which is completely false/erroneous.

A "teatotaler" is someone who does not drink alcoholic beverages.

You were asked a perfectly good and legitimate query,and supplied a ridiculous answer.

229 posted on 04/24/2004 11:39:27 PM PDT by nopardons
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To: All
Here we go again. Personally, I feel that the only way you can have a valid, carefully considered discussion on this topic is to limit it to those who must grapple with the day to day problem of dealing with intractable life-altering, chronic pain. Once you have dealt with the pain (literally, as well as figuratively) THEN perhaps you are entitled to tell others what they should (but usually it is more along the lines of how you should NOT ) deal with it.

As one who is receiving medical help to try to cobble together a life still worth living despite pain of incredible proportions.... I can't tell you how grateful I am that we have medications available and how exceedingly frustrated I am that the under 10% who abuse them seem to set the standard for the 90% who do not. It just makes me want to throw up that once this discussion starts it seems to be divided into the camps of the "liberal on drug policy....libertarians" and the "uptight, let them take aspirin or grit and bear it" camps.

Not that I believe for an instant that my opinion (or even more compelling---personal experience) will change your mind, but for what it is worth, please consider the following. After YEARS of suffering because many doctors have been cowed into thinking opioid and addict are the same word.... for an instant the medical profession gained some clarity on the issue of actually agressively TREATING pain.

In that instant, I was granted permission to begin to LIVE again.... not pain free, but free enough to make the difference of bed-ridden to being able to spend a morning with my young grandchildren. I am grateful that I can sweep the porch, work on crafts, fix a meal..... grateful to water the plants.... and get on my knees to THANK God, who in His mercy has given me this period of grace and freedom to think, act and react with clear thinking.

I have tried Oxycontin, but am currently taking a relatively high daily dose of methadone (yes, the same drug used to treat heroin addiction) because it has been found to be a relatively cheap, effective, and highly tolerated way to treat systemic pain which is aggravated by additional joint inflammation. Guess what? I'm not addicted.... I am able to function! When you take what you need, WHEN you need to take it.... the result is phenomenal. Granted, my reason for taking it is not to get high, it is to function.

I urge those of you who want to ban a good thing to consider that more of us are helped than harmed by the current trend that allows treatment for pain. I see your efforts to throw the "baby out with the bath water" as a threat to my constitutional rights. Ultram, Cataflan, etc. while good medications were far to mild to help.

What I am confused by is the strident drone of those who have no pain to deal with to tell me that I have no right to deal with an issue which affects me greatly. There are laws on the books to deal with addicts, so why do you want to deal with those of us who are not?

Personally, I am far from libertarian, and socially more than fiscally extremely conservative.... but totally baffled by the open derision of many who believe that when it comes to the issue of prescription pain killers, anyone who sees them in a good light MUST be in favor of addiction and social chaos. The bottom line is this. If you are ever faced with the choice of living or existing, your opinion may change. In the meantime, laws exist to deal with addicts, let the rest of us act like adults and get medical treatment with the correct drugs, in a high enough dosage to let us function. Be happy that we can contribute to society... and find another (and greater) issue to fight.... "hill is too small to die on...."
230 posted on 04/25/2004 12:46:27 AM PDT by snickeroon (walk a mile in my shoes and we'll talk)
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To: nopardons
A "teatotaler" is someone who does not drink alcoholic beverages.

OK, so where do you draw the line? Would a teatotaler be OK with kava kava? Nicotine? St. John's wort? How about recreational scorpion stings (yeah, that's a current thread on FR)? Nitrous oxide (be sure to buy food-grade)?

How do you define it? Anything but alcohol? Or what?

231 posted on 04/25/2004 4:31:19 AM PDT by eno_ (Freedom Lite - it's almost worth defending)
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To: Jorge
I did. Mechanism of action unknown, except that it has small agonist activity for the mu opiate receptor.
232 posted on 04/25/2004 4:32:48 AM PDT by jammer
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To: snickeroon
The lesson here is that truly understanding what it means to be a conservative is a benefit:

Some people think it means wanting everything the Left does not want, and everything a cop would wish for.

The true path is to see the Constitution as the Founders saw it, and to see today's laws in light of whether the Founders would have seen the as neccessary.

Perhaps the key pivotal event is the New Deal-era court stacking that enable that arch-Leftist FDR to redefine what the FedGov could stick its nose into. Cutting the functions and size of the FedGov back to pre-New Deal size is an excellent guide to what is the right thing to do.

Less regulation - a LOT less! Fewer government hacks. Fewer laws more carefully enforced. It's the recipe for good things in all issues, not just pain medicine.
233 posted on 04/25/2004 5:27:28 AM PDT by eno_ (Freedom Lite - it's almost worth defending)
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To: nopardons
I NEVER voted even once,for Clinton.Did you?

Of course not. But a majority of people did. Twice. The fact that they did, especially the second time, shows me that the American populace in general is ignorant. Listen to some of Sean Hannity's "man on the street" interviews if you need more proof.

234 posted on 04/25/2004 7:50:49 AM PDT by jmc813 (Help save a life - www.marrow.org)
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To: nopardons
Do you think I'm a drug abuser? I've been taking opiates of one form or another since 11/94 for chronic pain due to a botched 3 level cervical fusion. I also take muscle relaxers, anti-depressant and a sedative medication used to treat migraine headaches. Mine is a daily regimen of these medications. Even with the amount of meds I take, I don't get full pain relief. 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. The high feeling fades after 30 minutes or so and then I become as functional as I'm capable of being.

You would take away a short period of time where I relax, get floaty and forget for a short time about pain. Do you think I'm a pro-doper? If so, I thank you for your label and your condemnation.

I also am not a guy. I don't take my legally prescribed drugs for something as minor as a hangnail.

I also gave birth 27 years ago via c-section and was prescribed a narcotic pain reliever. What's funny about the pain med they gave me then was the doctor was over dosing me. The nurses insisted I take 2 every 2 hours which left me unable to get out of the hospital bed as they wanted me to do. I had to raise a large stink in order for them to discontinue bringing me 2 percodans every 2 hours.
235 posted on 04/25/2004 11:10:22 AM PDT by Sally'sConcerns (It's painless to be a monthly donor!)
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To: neverdem
Pain relief **is** euphoric--the cessation of pain will make you kiss the nurse's hand, or feet, even--but anything that'll keep painkillers around to relieve pain, I'm for.
236 posted on 04/25/2004 11:14:37 AM PDT by Mamzelle (for a post-Neo conservatism)
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To: neverdem
What would be really great would be some kind of super asprin. Pain relief but no hook.

My back acted up a couple of days ago. Thankfully 1000mg of asprin put paid to that, but I have great sympathy for those who have pain that over-the-counter stuff can't handle.

237 posted on 04/25/2004 11:24:13 AM PDT by LibKill (Yep, we are cowboys. WYATT EARP cowboys.)
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To: Monty22
bull and $hit. They obviously can make nonaddictive painkillers, they're already doing it well.. Celebrex and Ultram are great.

Celebrex is a Cox 2 inhibitor NSAID. Can't take it with a lot of drugs, such as Coumadin, or history of ulcer.

Ultram is pretty good, but SURPRISE, can cause addiction as well.

Both are far more expensive then some of the opiates, which are actually great drugs when used correctly.
238 posted on 04/25/2004 11:26:44 AM PDT by Kozak (Anti Shahada: " There is no God named Allah, and Muhammed is his False Prophet")
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To: AntiGuv
The solution in the sense you mean would be to synthesize and equally effective, nonaddictive painkiller.

The way, heroin was originally developed as a "non addictive" replacement for Morphine.
239 posted on 04/25/2004 11:36:05 AM PDT by Kozak (Anti Shahada: " There is no God named Allah, and Muhammed is his False Prophet")
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To: Monty22
bull and $hit. They obviously can make nonaddictive painkillers, they're already doing it well.. Celebrex and Ultram are great.

Get over your druggie ideals, that's soooo old.

Celebrex is an NSAID which means it's an anti-inflammatory the same as motrin, aspirin and vioxx.

Here's some information about your so-called non-addictive painkiller Ultram:

http://www.orthomcneil.com/healthinfo/painmanagement/products/ultramfaq.html

Who Should Not Take ULTRAM®? Cases of abuse and dependence on ULTRAM have been reported. ULTRAM should not be used in opioid-dependent patients. Since ULTRAM can reinitiate physical dependence, it is not recommended for patients with a tendency to drug abuse, a history of drug dependence, or chronically using opioids.

Additionally, anyone who has had an allergic-type reaction to either ULTRAM or any product containing an opioid medicine (like Tylenol®* with Codeine) should not take ULTRAM.

Can I Take ULTRAM® Along with Other Medications? There are certain medications that should be used with caution while taking ULTRAM. These other medications include tranquilizers, sleeping pills, antidepressants, and opioid pain medicines. Be sure to talk with your doctor about all other medicines you are taking before starting your prescription for ULTRAM.

Does ULTRAM® Have Side Effects? All medicines, including ULTRAM, can cause side effects. People who experienced side effects with ULTRAM in medical studies usually did so at the beginning of treatment. The most frequently reported side effects experienced with ULTRAM were constipation, nausea, dizziness, headache, somnolence, and vomiting. Patients should talk to their doctors about any side effects they experience while taking ULTRAM.

ULTRAM may impair your ability to drive a car or operate machinery.

Why would Ultram impair your ability if there wasn't some type of kick or high associated with it?

Seizures have been reported in patients taking ULTRAM.

Patients with a history of severe, life-threatening allergic (anaphylactoid) reactions to codeine and other opioids may be at increased risk and therefore should not receive ULTRAM

From the pdf file on Ultram: Ultram is a centrally acting synthetic opoiod analgesic.

Ultram may induce psychic and physical dependence of the morphine-type (u-opioid)

Ultram can be addictive per the manufacturer of the drug in the same manner as morphine.

240 posted on 04/25/2004 2:37:31 PM PDT by Sally'sConcerns (It's painless to be a monthly donor!)
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