Opiates are more common, but more controversial than ever -A Delicate Balance

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A Delicate Balance

Opiates are more common, but more controversial than ever

By Anne Harding

Ever since the United States government passed laws governing the

prescription of opioid drugs early in the 20th century, doctors and

regulators have been engaged in a balancing act, trying to use the

drugs to treat pain appropriately while preventing their abuse.

But growing use of opiate medications by patients with chronic,

non-terminal pain--which carries a small, but real, risk of

addiction--has made achieving balance even more difficult. A climb in

prescription drug abuse has paralleled the rise in legitimate use, and

law enforcement and regulatory crackdown efforts have made many

physicians afraid to prescribe pain medication to patients who really

need it.

" The person who suffers the worst is the patient, " says Heit, a

physician and chronic pain specialist, certified in addiction medicine

and practicing in Virginia.

A DEA FLIP-FLOP

Heit and others in the pain treatment field say the relationship

between law enforcement and physicians has taken a turn for the worse,

a reversal from 2002, when the Drug Enforcement Administration (DEA)

voiced intentions to act with " balance " in regulating prescription

narcotics.

Around that time, Heit says, the DEA approached a group of pain experts

to develop a document that would help clarify legal and clinical

issues. They came up with Prescription Pain Medications: Frequently

Asked Questions and Answers for Health Care Professionals and Law

Enforcement Personnel. The DEA released the document in August 2004,

complete with a press conference at the Washington Press Club. The

Journal of the American Medical Association reviewed it favorably.1

Two weeks later, the administration pulled the document from its Web

site, disavowing it " because it contained misstatements. " In November,

the DEA published an interim policy statement that some say is more an

effort to intimidate than to illustrate. For example, while the

original FAQ document stated that the amount of opiate medication a

physician prescribed or the number of patients in his or her practice

taking the drugs could not be used as the " sole basis for investigation

by regulators or law enforcement, " the new DEA statement said such

factors " may indeed be indicative of diversion, " and that investigation

is warranted " merely on suspicion that this law is being violated, or

even just because it wants assurances that it is not. " 2

" The word flip-flop comes to mind, " says Joranson, senior

scientist and director of the Pain and Policy Studies Group at the

University of Wisconsin Comprehensive Cancer Center and a member of the

principal working group that wrote the FAQ. Grant, a spokesman

for the DEA, says, " The withdrawal of the document doesn't represent a

change in our investigative emphasis or approach. "

Some speculate that the DEA withdrew the document after learning it was

going to be used in the defense of Hurwitz, the Virginia

physician convicted in December of 50 counts, including illegal

prescription of narcotic pain relievers to patients.

Hurwitz was prescribing opiate drugs to treat chronic, non-terminal

pain. While this is not why he was prosecuted, the practice remains

controversial in some medical circles, says Portenoy, chairman

of pain medicine and palliative care at Beth Israel Medical Center in

New York City. Such treatments may mean relief for " thousands, if not

hundreds of thousands, of patients, " but a shortage of safety data is

cause for concern.

RAPID GROWTH

Regardless, wider application of opiates has led to " very rapid growth "

in opioid consumption in the United States and in other parts of the

world, Portenoy says. The Automation of Reports and Consolidated Orders

System (ARCOS) has shown a steady climb in medical use of morphine,

fentanyl, oxycodone, and hydromorphone in the US from 1990 to 2001. The

amount of morphine, as measured in grams distributed, grew by 59% from

1990 to 1996, and by another 49% from 1997 to 2001.3,4

While European countries have seen a similar increase in legitimate

opiate use, cultural forces, including a generally less punitive

attitude toward drug addiction, have meant the medical community and

drug regulators are not at odds to the extent seen in the United

States.

Portenoy and others in the field say there is no evidence that a

contemporaneous rise in prescription drug abuse--with 2 million people

using prescription pain relievers for non-medical reasons in 2001 for

the first time, compared to 600,000 in 1990, according to the National

Survey on Drug Use and Health--has anything to do with growing medical

use of opiates.

Research shows that between 3% and 19% of individuals receiving opiate

treatment for pain will become addicted, according to Deborah Haller,

director of research in the Department of Psychiatry at St.

Luke's-Roosevelt Hospital in New York City. " Most experts in this field

would agree that if a person doesn't have a personal history of an

addiction problem, it's not a big risk, " she says.

CRUCIAL DISTINCTIONS

Much of the confusion, then and now, lies in the distinction between

dependence, which is associated with physical withdrawal symptoms, and

addiction. The definitions of the two phenomena have been tangled, with

physical dependence equated with addiction, rather than understood as

an expected consequence of regular opiate use.

In 2001, the American Pain Society, the American Academy of Pain

Medicine, and the American Society of Addiction Medicine published

definitions of tolerance, dependence, and addiction intended to clear

up the confusion. According to the document, addiction is characterized

by one or more of the following: impaired control over drug use,

compulsive use, continued use despite harm, and craving.

A problem remains, says Portenoy: There is no external validation of an

addiction diagnosis. It remains a matter of clinical judgment. And

abuse, or so-called aberrant drug-related behavior, is even more

difficult to define and appears more common. " When you look at these

kinds of issues from a diagnostic perspective, you can see it's

something of a morass right now, " he says.

Meanwhile, regulators have sought to crack down on the growing problem

of prescription drug abuse by targeting individual physicians and

pharmacists, making legitimate practitioners afraid even to deal with

patients in pain, Joranson says.

Joranson argues for a more systematic, " public health " approach to drug

abuse and diversion, involving a thorough investigation into the

sources of diverted drugs--whether they are criminals stealing pain

pills from drugstores and warehouses or fraudulent doctors. But the war

on drugs doesn't lend itself to such an approach, Joranson says;

headline-grabbing SWAT raids on physicians' offices and pharmacies tend

to be more popular.

Weaver, a physician certified in addiction medicine who runs

pain clinics through Virginia Commonwealth University Medical Center

and has published extensively on treating individuals with addiction

problems, says the best way to cope with the issue of pain treatment

and addiction is to carefully assess patients before prescribing

opioids to determine if they may be at risk for abusing them.

" I think if you're going to treat chronic pain in a doctor's office,

you need to be more structured than people have been, " says Jane

Ballantyne, chief of the Division of Pain Medicine at Massachusetts

General Hospital.

" We're beginning to see that we physicians have to take on board the

treatment of addiction as well as the treatment of pain, " Ballantyne

adds. " To ignore it is just to make matters worse. "

Anne Harding (aharding@...)

References

1. N.V. Chandrasekharan et al., " -3, a cyclooxygenase-1 variant

inhibited by acetaminophen and other analgesic/antipyretic drugs:

cloning, structure, and expression, " Proc Natl Acad Sci, 99:13926-31,

2002.

2. J.A. Snipes et al., " Cloning and characterization of

cyclooxygenase-1b (putative -3) in rat, " J Pharm Exp Ther, Jan. 13,

2005; doi:10.1124/jpet.104.079533.

3. B. Kis et al., " Acetaminophen-sensitive prostaglandin production in

rat cerebral endothelial cells, " Am J Physiol Regul Integr Comp

Physiol, 2004, doi:10.1152/ajpregu.00613.2004.

http://www.the-scientist.com/2005/03/28/S38/1