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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
Which is precisely what I said.:-)
201 posted on 04/24/2004 1:27:08 AM PDT by nopardons
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To: nopardons
You haven't a clue;not a single one.

Sure I do. I am quite well-aware that my position is a minority position. I have never doubted that the vast majority of people are ignorant. In fact, I am regularly shocked that the stupidity of the world manages to exceed even my expectations no matter how far I lower them.

If the majority agreed with me, then I would never bother advocating a change, because 'the system' (in the grander sense) would already be as I would have it (obviously). To state over and over that a majority disagrees with me is to state nothing but the obvious.

Most precepts which are commonly or even near-universally held today were at some point in time a minority viewpoint.

202 posted on 04/24/2004 1:27:52 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: nopardons
You were referring to my comment which was referring to that, amongst other things.
203 posted on 04/24/2004 1:28:40 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: AntiGuv
Excuse me, what exactly would you change? You've not made your position clear on this thread.

I want to limit addictive drugs and put them out of the market for medical use. To replace them with safer, healthier alternatives.

What's your scheme?
204 posted on 04/24/2004 1:30:24 AM PDT by Monty22
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To: nopardons
I've had enough tonight. I slept after work, came on and saw this, thought it was a productive thread about future medication, and got attacked by the libertarians.

Goodnight.
205 posted on 04/24/2004 1:33:46 AM PDT by Monty22
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To: Monty22
You had responded to a point about guns earlier in the thread--

I'm as pro gun as anyone, did LBJ and FDR support that somehow?

--so I thought a brief yes/no question on the Second Amendment would not be out of line.

Do you think the Second Amendment means that NO government may infringe on the RKBA?

206 posted on 04/24/2004 1:35:28 AM PDT by Ken H
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To: Ken H
Before I go to bed..

Ok. semi-autos, little restriction

The form now isn't so bad. I'd have a time limit on felony and mental defective stuff, probably 5 years.

I like the class 3 setup for full auto/supressors.. Without the Reagan ban.. Should be able to get new stuff, with same fees as now and some extra background checks.

207 posted on 04/24/2004 1:38:47 AM PDT by Monty22
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To: Monty22
I'm off too...good night.
208 posted on 04/24/2004 1:43:52 AM PDT by nopardons
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To: Monty22
Excuse me, what exactly would you change?

That is a rather involved question and I'm uncertain I want to get into such an in-depth discussion, especially when it's almost certainly to no purpose (I'm fairly certain neither of us is going to persuade the other).

I can tell you right off the bat where our fundamental disagreement arises: I do not view 'getting high' as an inherent evil of its own accord; you clearly do. I certainly do not view it as inherently criminal, even when it is criminalized. To the extent that the thread has gotten off a productive track, as you characterize it, it is based on that essential divergence in our views.

I have no problem with limiting addictive drugs as much as possible to proper usages; I do not agree with putting them out of the market for medical use unless an equally effective alternative is found. I certainly do not object to the discovery of safer, healthier alternatives so long as they do not replace something of superior qualities.

From the most basic perspective, I would not conflate drug use with drug abuse as if they are one and the same. The rest of what I would change directly follows.

209 posted on 04/24/2004 1:44:04 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: Monty22
I actually stood up and fought on this thread, and reduced them to shreds.

That's cute that you think so.

210 posted on 04/24/2004 1:44:54 AM PDT by jmc813 (Help save a life - www.marrow.org)
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To: Monty22
I'm not clear on what you mean.

In your opinion, does the Second Amendment mean that adult citizens have a guaranteed right to own a firearm, even if a State or city says otherwise?

211 posted on 04/24/2004 1:51:19 AM PDT by Ken H
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To: AntiGuv
Sheeeeeeeeeeeeeeesh...just a wee bit of a egomaniac,aren't you?You're "brilliant",anyone who doesn't agree with you is ignorant and stupid beyond your ken.Yeah,right,and I'm the Queen of England...BODECIA!

Hmmmmmmmmm..."most precepts which are commonly or near-universally held today were at some point in time the minority?Thus spake Zarasth...errrrrrrr,you.That's one of the funniest,silliest,most wrongheaded things I have EVER read on FR and I've been reading posts on FR for more than SIX years now.

Marriage is between one man and ones woman,or one man and some women (in some cultures),NOT between two men or two women has been a pretty UNIVERSALLY held precept,for many millennia and that's just for starters! And you,YOU have the gall to claim that the vast majority of people are ignorant? GO LOOK IN THE NEAREST MIRROR...THEREIN YOU'LL SEE THE VISAGE OF ANOTHER IGNORANT PERSON!

Good night,it's late,and you are far too delusional,arrogant,and egomanical to lose anymore sleep debating.

212 posted on 04/24/2004 1:59:48 AM PDT by nopardons
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To: Monty22
Oh, and I will confess that part of the reason why my specific position is unclear is because it is indeed unclear. I have a set of principles that I would apply to drug policy that is starkly at odds with that currently prevailing. I am uncertain how that translates to specific policies because I would refine the details gradually as new policies were implemented and one could study what works and what does not.

I am not an extremist nor am I particularly fond of precipitous change, even when it is change in the right direction. I am generally the type to prefer methodical, well-considered, incremental steps toward an ultimately ideal policy arrangement. I realize that much of this is platitudinous, but that's in short why I do not have a crystal clear proposal of how I would rearrange things.

If I could change two things tomorrow generally related to Prohibition then I would legalize marijuana and I would implement a treatment-first approach to law enforcement. But that's digressing from the particular point at hand (medical use of narcotics). In general, I would approach drug abuse first and foremost as a medical problem and not as a law enforcement problem, but that's another cliche.
213 posted on 04/24/2004 2:04:42 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: nopardons
You're getting hysterical. I am pleased that my post had precisely the intended effect. Heh. =)
214 posted on 04/24/2004 2:06:27 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: AntiGuv
Actually, I am quite calm,so calm,that I am falling asleep.

The ONLY "hysteric",on this thread now,is you Nappy.:-)

215 posted on 04/24/2004 2:12:05 AM PDT by nopardons
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To: nopardons
Have a g'night. Sleep well!
216 posted on 04/24/2004 2:15:43 AM PDT by AntiGuv (When the countdown hits zero - something's gonna happen..)
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To: Jorge
My bet is you are not on the usual opiate type pain killers such as vicodin, oxycodone etc. Otherwise the typical antidepressants would be very dangerous.

Generic version of vicodin also known as hydrocodone.

The fact is using opiates such as heroin and speed together are considered deadly.

The fact is speed has a completely different chemical composition than anti-depressants do. Vicodin is synthetic codeine and is nowhere near the strength of morphine. (heroin)

As I said, it's traditional protocol for chronic pain patients to be prescribed an anti-depressant as well as pain medication. In no way is this similar to speed and heroin.

You're right, all of this is temporary and will stop when medical science comes up with a restorative operation or I die (hopefully of old age).

217 posted on 04/24/2004 4:13:41 AM PDT by Sally'sConcerns (It's painless to be a monthly donor!)
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To: Monty22
What does the 2nd have to do with drugs? Drugs aren't arms that I can tell.

Are you familiar with the Robert Wood Johnson Foundation?

218 posted on 04/24/2004 4:43:45 AM PDT by jmc813 (Help save a life - www.marrow.org)
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To: AntiGuv
I am quite well-aware that my position is a minority position. I have never doubted that the vast majority of people are ignorant.

Rest assured that your opinion is NOT in the minority here on FR where the ignorance rate is much les than society as a whole.

219 posted on 04/24/2004 4:45:10 AM PDT by jmc813 (Help save a life - www.marrow.org)
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To: nopardons
And you,YOU have the gall to claim that the vast majority of people are ignorant?

We elected Bill Clinton twice for crying out loud. Yes, most people are ignorant, sadly enough.

220 posted on 04/24/2004 4:47:24 AM PDT by jmc813 (Help save a life - www.marrow.org)
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