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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: LisaMalia
Me too, I've had very severe pain and had to resort to hydrocodone. I wish there were more options. Thankfully I simply took the amount prescribed, and didn't have a problem.

Apparently though, the ideal of making drugs that cause a high to be harder to get is a real problem with some people, sadly.

They want to fill the emotional blankness with the drug. Not stop the pain.
61 posted on 04/23/2004 7:45:10 PM PDT by Monty22
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To: Monty22
I'm for addiction-free treatment without any highs. Just relief from pain.

I a way I agree, but not 100%.

In some cases I believe the "high" is just as important as a psycholical relief from mental depression/anxiety etc. associated with the disease or injury causing the pain, as the actual physical pain relief is.

I don't see what's wrong with a person who's had some traumatic injury that's scared the crap out of them and put them in a state of mental trauma as well, not only to get the effects of relief from the physical pain but also the psycholical relief of the "high" to help them switch to a "everything's going to be alright" state of mind.

I think the "high" is just as important as the pain relief when if comes to dealing with some conditions.

62 posted on 04/23/2004 7:46:51 PM PDT by Jorge
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To: Monty22
Sorry for calling you a dumb***. Don't call me a druggie. BTW, I have chronic pain in my left leg and could easily get narcotics prescribed if I wanted. I don't because I can't think clearly enough to write well on them. I am not a druggie by any stretch. A double espresso would probably do me in..
63 posted on 04/23/2004 7:47:25 PM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: Jorge
The 'high' is an emotional situation, not anything related to physical.

For emotional trauma, they can get treatment tuned for it, such as antidepressants that are effective.

This pro-high talk is insane, and the most anti-moral thing I've ever heard.

But, since you're a 20 year pothead you said, what can I expect since that's your crutch in life?
64 posted on 04/23/2004 7:48:41 PM PDT by Monty22
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To: jammer
"Celebrex and Ultram are great."

Sure. But it would be nonsensical to think that they--especially Celebrex--have the analgesic potency of opiates.

Ultram actually IS an opiate. (synthetic)

65 posted on 04/23/2004 7:49:14 PM PDT by Jorge
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To: AntiGuv
From my experience, pro-druggies are the same as pro-islam people. They are knee deep into it, and have an agenda.

I know it's not always the case, sometimes it's just ignorance. But the trend is clear.
66 posted on 04/23/2004 7:50:13 PM PDT by Monty22
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To: Monty22
Why don't you get your self righteous nose out of other peoples lives.
67 posted on 04/23/2004 7:54:36 PM PDT by lucidloony
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To: Monty22
Somewhere I read a report that said people who take pain killers do not become addicted if they really have pain. Only people taking pain killers for fun do! Huh? I have pain. I cannot get pain pills to stop the pain! I could become addicted! But, I won't because I can't get them! I will suffer alot, which is good, it is not addicting.
68 posted on 04/23/2004 7:55:03 PM PDT by wingnuts'nbolts
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To: Monty22
Well, in my case I am not a druggie (or ignorant, but let's leave that aside). I had a short period of Percocet addiction after surgery in 1997 and a nasty withdrawal, if that makes you happy.. =)
69 posted on 04/23/2004 7:55:38 PM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: AntiGuv
So.. You'd rather not find a non-addictive replacement for percocet?!!?
70 posted on 04/23/2004 7:57:46 PM PDT by Monty22
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To: Jorge
Worse yet, these drugs Celebrex and Vioxx attack the kidneys! So, they cannot be taken regularly! Sporatically, maybe, if only you could get a Doctor to perscribe and believe that you do not want kidney problems and will take the drug sparingly.
71 posted on 04/23/2004 8:00:03 PM PDT by wingnuts'nbolts
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To: Monty22
Geeezz.. I don't have a problem with researching and marketing non-addictive painkillers. I think it's a great idea!!

I have a problem with (a) frequently inadequate pain management that causes unnecessary suffering for many people; (b) the peripheral institutions of authoritarian coercion & control that have been built up around the Prohibition War; and (c) the immense amount of money wasted in misguided policies in that endeavor, that could be put to far better use.

I basically think that the objectives can be better achieved to the extent they can be achieved by much preferable methods. If I have any problem with this proposal above, it is more so in what motivates it and how it's likely to get implemented than certainly anything about the product itself.

72 posted on 04/23/2004 8:05:10 PM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: Monty22
I think that the point is that none of the current drugs are as of yet a replacement for the strong narcotic pain management drugs. And until there is a "psudo-narcotic" that can fool the brains dopamine receptors, there will be no replacement for them. Being someone who had to take them after I hurt my back so bad I was prenatally in tears, I thank God for creating this plant with such medicinal value.
My grandmother had cancer and was in such pain that she couldn't stand it. And still the doctors were reluctant to prescribe a strong pain med. And it was a fatal illness. And they worried about addition? She finally went to hospice and the were able to give morphine to keep her comfortable in her last days..

Sorry for my digressing, I tend to go on sometimes :)
73 posted on 04/23/2004 8:08:03 PM PDT by CMOTB (Do not write on or below this tagline)
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To: CMOTB
Oops I meant practically in tears. Maybe those narcotics have effected my spelling. (major sarcasm)
74 posted on 04/23/2004 8:14:49 PM PDT by CMOTB (Back up you hard drive. Even Jesus Saves.)
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To: CMOTB
I hear what you are saying.

Pain sucks. But, people made it how many hundreds of thousands of years?

Now we have medications that are flawed. We need to work on fixing it so it'll fix the problem. For the terminally ill.. Well, give them what they need. Frankly, just euthanize them first. Why make them suffer at all for a few days/weeks?

I'd rather them just pass instead of a drugged/pain haze.
75 posted on 04/23/2004 8:15:16 PM PDT by Monty22
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To: Monty22
Thats a matter of religious belief. She considered life to be kept as a gift from God. And was grateful for the blessings in her life, and let God decide when it was time. And God didn't want any of us to suffer, I believe thats why these and future meds are possible.

76 posted on 04/23/2004 8:20:21 PM PDT by CMOTB (Back up you hard drive. Even Jesus Saves.)
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To: Monty22
The 'high' is an emotional situation, not anything related to physical.

Actually they go hand in hand.

Anyone who has been treated for extreme pain with these drugs WILL tell you that the emotion situation of the trauma related to the pain was VERY MUCH helped by the "high" that went along with the pain relief.

This helped calm them psycholically and countered the fear and anxiety..which was an important part of the relief and healing process.

For emotional trauma, they can get treatment tuned for it, such as antidepressants that are effective.

With all due respect, this shows how little you know about medications and their safe use.

Antidepressants are stimulants which have the opposite effect of pain killers and could be dangerous if used in combination with them.

NO Doctor would prescribe antidepressants in combination with pain killers. That would be stupid.

This pro-high talk is insane, and the most anti-moral thing I've ever heard.

We're talking about SUFFERING here. Both physical and mental when it comes to many conditions, diseases or injuries.

When you are so upset that people going through such things might feel any kind of "high" as part of their relief from suffering...I hardly thing this gives you the moral high ground.

Most of us who've had loved ones go through the suffering of cancer etc. are only too glad to see them not only get relief from the physical pain but to be able to feel GOOD for a change...

But, since you're a 20 year pothead you said, what can I expect since that's your crutch in life?

Let me give you some advice;
You're not going to win anybody to your point of view by making personal attacks.

Secondly if you're going to bring up someone's personal life, at least be honest about it.

I said I WAS a real pothead for 20 years. From the time I was 15 years old until my mid 30's. I am turning 50 years old and am no longer a pothead. Not for a LONG time.

I was honest enough to reveal my past. You should be honest enough not to distort it in order to malign me anytime I disagree with you.
Fair enough?

77 posted on 04/23/2004 8:23:17 PM PDT by Jorge
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To: Monty22
For the terminally ill.. Well, give them what they need. Frankly, just euthanize them first. Why make them suffer at all for a few days/weeks?

Why don't you let that decision be up the the patient and their physician?

I'd rather them just pass instead of a drugged/pain haze.

How about you keep your big fat nose out of other people's business.

78 posted on 04/23/2004 8:24:02 PM PDT by Ken H
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To: Jorge
As a 20 year admitted pothead, I'll just ignore anything you ever say.. Fair enough?
79 posted on 04/23/2004 8:26:04 PM PDT by Monty22
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To: neverdem
I figure that after suffering through a really bad migrain, I deserve a buzz from my medication.
80 posted on 04/23/2004 8:33:56 PM PDT by zook
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