The new target in the war on drugs?
Some critics think so, and they're blaming the DEA
and other agencies for trying to make up
for past failures.
May 19, 2006
By: Wayne J. Guglielmo
At a time when medical science offers doctors a potent arsenal of opioid and other drugs to treat pain, many patients still can't get the relief they need.
The numbers are stunning. More than 50 million Americans experience chronic pain, according to data cited by the American Pain Foundation. Nearly 25 million others have bouts each year of acute pain, typically as the result of an injury or surgery. Of those who need relief, as few as one in four receive the proper treatment.
Why are people suffering, despite remedies at hand to help them? Certainly, pain specialists are in short supply—there are fewer than 6,000, by one estimate—and so are the primary care nonspecialists who have enough knowledge and training to pick up the slack. But it's doctors' fear of being targeted as criminals that creates the biggest barrier to proper pain treatment, many experts say.
Doctors weren't always afraid of being led away in handcuffs. In the past, those who treated pain aggressively were more afraid that their medical board, especially in certain parts of the country, would come in and restrict their privileges or yank their licenses altogether. (See, "Pain Control: Did Dr. Lewis cross the line?" March 7, 2003). These days, however, many in and outside of the profession give medical boards higher grades. "Pain management has been a focus for us for the past several years, and we're very pleased at how our members have responded," says Dale L. Austin of the Federation of State Medical Boards.
But as the media and others have talked up the problem of Rx diversion, doctors have come under increasing surveillance by the Drug Enforcement Administration and its counterparts in the states. True, diversion is a problem in some areas, say critics, but they fault the DEA and state agencies for the way they're addressing the problem, accusing these agencies of sometimes doing an end run around medical boards.
"The DEA and state agencies have been treating doctors as if they're drug dealers," says Ronald T. Libby, a professor of political science and public administration at the University of North Florida. "Doctors have become part of the war on drugs."
Such charges, says the DEA, are wildly overblown. Drugs are diverted primarily through pharmacy robberies, prescription forgeries, and fraudulent Internet sales, says Rogene Waite, a DEA spokesperson, in a written statement. "Doctors who prescribe controlled substances in their legitimate medical practice have nothing to fear from DEA." (The agency declined a Medical Economics request for an interview.)
But it's the phrase "in their legitimate medical practice" that worries many people. Under the Controlled Substances Act (Title II of the Comprehensive Drug Abuse Prevention and Control Act, passed in 1970), the DEA registers physicians and other professionals to prescribe controlled substances as long as they do so in the "usual course of their professional practice." Over time, say critics, the DEA has taken this to mean that it can decide when doctors treating pain are practicing legitimate medicine.
That interpretation, these same critics say, is a bold example of the federal government overstepping its authority and treading in areas traditionally reserved for state medical boards. This January's Supreme Court ruling in Gonzalez v. Oregon appears to support that view, at least when it comes to physician-assisted suicide. Advocates of better pain treatment hope the physician-assisted suicide ruling—which said the Feds can't threaten doctors who prescribe controlled substances to induce death—will boost their cause, as well. (See, "Special Report: Assisted suicide survives—narrowly," Feb. 17, 2006).
Meanwhile, many say, the government's mission has resulted in more physician investigations and high-profile prosecutions, which, in turn, have sent a bigger chill through the prescribing community and exacerbated the epidemic of undertreated pain.
DOCTORS ARE EASY TO FIND
AND THEY DON'T CARRY GUNS
For most of its 30-plus-year history, the DEA has invested its primary energies in stemming the flow of illegal black market drugs, such as heroin, cocaine, "crack" cocaine, ecstasy, and marijuana, says the University of North Florida's Ron Libby. In the public's mind, this is the traditional image of the war on drugs, and, of course, it's still going on.
But, beginning in the late 1990s, two things happened to redirect more of the DEA's energies elsewhere. First, the agency came under withering criticism from Congress for not demonstrating greater progress in the war on drugs, despite big annual budget increases. Second, its administrative overseer, the Department of Justice, began trumpeting another and potentially bigger threat menacing the nation, and especially rural areas. This threat was the diversion and abuse of Schedule II opioids, in particular OxyContin or "hillbilly heroin," as the press dubbed it. According to a statement to Congress by a DEA official, the agency has "never witnessed such a rapid increase in the abuse and diversion of a pharmaceutical drug product."
In April 2001, the DEA put in place the "OxyContin National Action Plan," intended to stop the diversion and abuse by focusing on both bad prescribers and bad patients. To officials within the agency, the plan was simply a legitimate law-enforcement response to "a new generation of prescription drugs and their abuse." But, to critics, the DEA had engaged in a sleight of hand, focusing on prescription drugs and prescribers in order to divert attention from its own failure to staunch the flow of heroin, cocaine, and other black market drugs.
"If the battles you're fighting are being lost, then, to win the war, find battles that you can win," says David Brushwood, a professor of pharmacy health care administration at the University of Florida, Gainesville, and a critic of government narcotics policy. "Doctors are more conspicuous and easier to find than drug dealers, and, besides, they don't have guns and they don't shoot back."
Whatever the truth of the matter, to carry out its plan, the DEA hired hundreds of new drug diversion investigators, while also extending its presence into sparsely populated communities through its State and Local Task Force Program. According to the agency's website, by mid-2005, the program had expanded to 217 state and local task forces, staffed by 1,232 DEA special agents and 1,980 specially deputized state and local police officers.
The action plan has yielded results. In a statement last September to Congress, Joseph T. Rannazzisi of the Office of Diversion Control said that, since 2001, the "DEA has initiated 720 OxyContin investigations, which have resulted in 812 arrests."
The agency wouldn't disclose how many of those arrests involved physicians. But documents obtained from other sources indicate that, for 2004, DEA and state authorities arrested a total of 50 doctors, mostly in connection with OxyContin and hydrocodone and related products. Actual convictions resulting from DEA investigations totaled 24 in fiscal year 2004 and 39 the following year.
Such numbers, DEA officials say, give lie to the notion that the agency is out to get doctors, especially in light of the total pool of nearly 1 million practitioner registrants. (Besides doctors, the pool contains smaller numbers of dentists, podiatrists, veterinarians, and naturopaths.)
But some people have challenged the agency's math. Only a small portion of that registrant pool, they say, prescribes powerful pain meds to patients with any regularity, making it somewhat more likely that these doctors could be arrested. More important, they say, is the fact that the government investigates many more prescribers than it actually arrests or convicts—in fiscal year 2004, investigations totaled 737, not including investigations by the DEA's state and local task forces—and it's this threat alone that's enough to send chills up doctors' spines.
"All it takes is one investigation for your livelihood to go down the drain," says Will Rowe, executive director of the American Pain Foundation. And that makes doctors overly cautious, says Brushwood: "If I'm a doctor and I hear that my colleague, Joe, down the street is being looked at, I will adopt the most conservative approach possible to avoid even being investigated."
And the Feds aren't the only ones looking over doctors' shoulders. States and counties have their own initiatives, says Fred N. Davis, a pain management specialist and co-founder of ProCare Systems, a company that develops and manages full-time pain management practices.
At least two took place in his own state of Michigan. In one case, says Davis, a new state prosecutor, working on a tip from the neighborhood pharmacist, conducted a sting directed at a small-town internist, who was later charged and tried for inappropriately prescribing Vicodin. "The jury was out for a couple of hours before totally acquitting him," says Davis. "But, at that point, his life was ruined. He had to sell his medical office building to pay for his defense, which cost $100,000. And the negative publicity forced him to close his practice and move to another town, which meant the patients in that town didn't have a doctor."
NOW YOU SEE IT, NOW YOU DON'T:
THE VANISHING FAQ
In an attempt to minimize such scenarios, at least at the federal level, the DEA, in August 2004, posted a document on its website that spelled out, in Q&A form, "the clinical and regulatory issues surrounding the prescription of controlled substances." The working group responsible for the FAQ, as it came to be known, consisted of some of the most well-respected names in the field. Also in the working group was a highly placed official from the DEA.
Although some patient advocates thought it didn't go far enough, most applauded the document for laying out a balanced policy—one that asserts, in the words of the group, "that efforts to prevent abuse of opioid analgesics . . . should not interfere with medical practice and patient care." Among other things, the FAQ reminded doctors that they could:
prepare multiple scripts on the same day, with instructions to fill on different dates;
authorize a pharmacy over the phone to fill a prescription, in the case of a bona fide emergency; and
refill Schedule III, IV, and V prescriptions up to five times within six months.
The FAQ also reminded physicians that, as far as the federal government was concerned, there was no ceiling on the amount of a single prescription, although some states imposed one.
The document's final Q&A addressed the $64,000 question, one that people on both the law-enforcement and treatment sides wanted clarified: "Do the number of patients in a practice who receive opioids, the number of tablets prescribed for each patient, or the duration of therapy with these drugs by themselves indicate abuse or diversion?" No, the working group responded, "and they should not be used as the sole basis for an investigation by regulators or law enforcement [italics added]." The injunction seemed to pierce at the very heart of the idea that the Feds could determine what constituted good medicine.
Even for skeptics, the agency's apparent statement of principle was welcome news. But less than two months later, the FAQ vanished from the DEA's website, without an explanation from anyone. Then, after a month of silence, the DEA issued an interim policy statement in the Nov. 16, 2004 Federal Register.
After noting that the original document had been withdrawn because it contained "misstatements" and because it wasn't an "official statement of the agency," officials proceeded to set the record straight.
On the big question of what indicators might prompt an investigation, it backpedaled. All the quantitative measures mentioned in the FAQ—"though not necessarily determinative—may indeed be indicative of diversion," the statement said. Then the DEA added, quoting a famous Supreme Court decision:"It's a longstanding principle that the Government 'can investigate merely on suspicion that the law is being violated, or even just because it wants assurances that it is not.' " The agency also backpedaled on several other points, including permitting doctors to write multiple prescriptions on the same day.
For some, the timing of the agency's announcement seemed suspicious: In revising its stance when it did, was the DEA simply laying down a general principle of how it intended to proceed from now on? Or was it, at the behest of the DOJ, also ironing out any policy inconsistencies so that alert defense attorneys couldn't seize on them to derail ongoing prosecutions, including that of Dr. William Hurwitz, the Virginia pain specialist then on trial? (On Dec. 16, 2004, Hurwitz was convicted on 50 counts of conspiracy to traffic in controlled substances and several other charges; his conviction is now under appeal.)
Whatever the case, the agency's policy reversal alone was enough to make the patient advocacy community howl—and to provoke only somewhat more tempered responses from other groups, including the American College of Physicians. Said then ACP President Charles K. Francis in a letter to the DEA deputy administrator:
We're concerned that the interim statement "is causing confusion and will have negative effects on the care of patients." Francis went on to say that the withdrawal of the FAQ in October "itself sends a message that could have a chilling effect on appropriate pain care."
A response also came from another and more surprising quarter—the National Association of Attorneys General. In a letter to DEA Administrator Karen P. Tandy, the states' top law-enforcement officials said that the new document "emphasizes enforcement, and seems likely to have a chilling effect on physicians engaged in the legitimate practice of medicine."
Feeling the heat, the DEA last August published a "clarification" of its interim statement. It left unchanged the big question of what factors could signal an investigation, as well as its stance on same-day multiple prescriptions. On this last point, however, it sought to address the "mistaken impression" that patients who'd previously seen their doctors every three months in order to pick up a prescription would now have to see them every month. Not so, said the agency, although for some patients it might not be a bad idea.
At press time, the DEA said that a final policy statement is due out shortly and will address the other questions that commentators have raised.
IT MAY BE BAD MEDICINE BUT THAT'S NOT A CRIME
Complementing the DEA's get-tough enforcement policy is the Department of Justice's equally tough prosecutorial strategy. That strategy is to commingle civil and criminal standards in order to win a criminal conviction, says Eli D. Stutsman, an Oregon attorney who's handled the appeals for many such cases and was one of the lead attorneys in the Oregon Death with Dignity Act case before the Supreme Court this year. A recent case, now on appeal, illustrates this strategy in action, and what many view as its inherent problems.
On Sept. 24, 2004, 61-year-old internist Dr. Bernard Rottschaefer, who formerly practiced in Plum, PA, was sentenced to more than six years in jail, ostensibly for trading drugs for sex. He's currently free, pending appeal.
In his opening brief to the appeals court, Stutsman faults the government for bringing a weak case against his client. He argues that new evidence discovered since the trial shows that the prosecution's star witness—a 26-year-old drug addict who was in jail at the time on a variety of charges—perjured herself. On the stand, she claimed under oath that the defendant had entered into a drugs-for-sex deal with her with the unsubtle proposition, "You satisfy my needs, I'll satisfy yours." But in jailhouse letters to her boyfriend written prior to her testimony, she made clear that she'd lie to help the prosecution in hopes of getting a lighter sentence. Other female witnesses, also drug abusers, were shown to have lied, as well.
But Stutsman's appeal doesn't hang on whether the government argued a weak case, although he certainly thinks it did. He's also out to prove that it often ignored its criminal case and focused, instead, on proving that his client practiced bad medicine because he should have examined his drug-abusing patients more carefully and realized that they were lying.
To this end, the prosecution called a string of witnesses, including an expert who testified about all the ways that Rottschaefer had deviated from the standard of care. Even the DEA agent who'd conducted the initial office search was enlisted to make this point. Called to the stand by the prosecution, the agent testified that he'd reviewed the charts to see whether they "contained anything that would justify the issuance of the prescription."
But does the US Attorney General and the prosecutors who work for him have the right to decide whether a doctor is practicing good medicine? Stutsman thinks not.
"As we showed in the Oregon case, the Controlled Substances Act was never intended to allow an unelected law-enforcement official to make subjective medical determinations," he says, adding that federal prosecutors are now getting criminal convictions based on a civil standard of care. "If these doctors are guilty of malpractice, that's one thing—but malpractice isn't a crime."
Other attorneys are making similar appeals on behalf of their clients, including the attorney for Ronald A. McIver, a Greenville, SC, doctor who was sentenced last year to a 30-year term for conspiracy to dispense and distribute Schedule II drugs, among other violations. Ultimately, advocates hope, one of these cases may make it to the US Supreme Court and do for pain management what the Oregon case did for physician-assisted suicide.
Meanwhile, others are hoping that the top brass at the DEA, the Department of Justice, or the White House itself will step in and insist on a more balanced policy regulating opioids and other drugs.
"These are medicines first, and people tend to forget that," says the American Pain Foundation's Will "Many people need them to live normal lives—and, without medicine, their lives are hell."
EVERYTHING OLD IS NEW AGAIN:
THE HARRISON NARCOTICS ACT 1914
The government's scrutiny of doctors who prescribe narcotics dates back to the Harrison Narcotics Act, passed in 1914. As written, the law was never intended to prohibit doctors from prescribing morphine, opium, and other narcotics to treat pain and other afflictions. It was primarily a licensing measure, detailing doctors' responsibilities for accurate record-keeping. But buried in the law was a vaguely worded phrase—"in the course of his professional conduct"—that enabled law-enforcement officials to gauge not only what constituted professional conduct but its boundaries.
Based on this phrase, a variation of which law-enforcement officials rely on to this day, if a doctor was prescribing maintenance doses to an addict, that clearly exceeded the limits of professional conduct, since addiction was not a disease and addicts weren't patients. By the 1930s, thousands of doctors had been caught up in this Catch-22, leading to arrests, imprisonments, and professional and financial ruin.
Over time, Congress and the Supreme Court altered the "professional conduct" phrase to "professional practice" and incorporated it into new narcotics control legislation, namely, Title II of the Drug Abuse Prevention and Control Act or the Controlled Substances Act.
A DRUG TASK FORCE COMMANDER SPEAKS OUT
The Greater Warren County (OH) Drug Task Force is headed by Commander John J. Burke, a 32-year veteran of the Cincinnati police force and the president, since November, of the National Association of Drug Diversion Investigators.
Although Burke acknowledges that "the number of doctors involved in diversion is extraordinarily small," he says there's "no question that one bad doc with hundreds of patients can put a lot of pills on the street." These are the clear-cut, "egregious" cases, says Burke, cases where there's no doubt that what's going on is drugs for money or drugs for sex.
Despite this, bringing a case against a doctor is never easy, he says: "If Joe Blow is selling cocaine on the street, I don't have to overcome the fact that he has a license to sell cocaine, because he doesn't. But if Dr. Jones is prescribing OxyContin illegally, I do have to overcome the fact that he has a right to prescribe the drug. And that makes his case harder for a prosecutor to prove, and harder for him to accept in the first place."
Still, even Burke worries that, "as prescription drug abuse gets worse," a few inexperienced investigators and overzealous prosecutors could end up with a bad prosecution, one in which what appears to be overprescribing is, in fact, good pain management. "I think it's a rarity, but it could happen," he says.
And that, of course, would only inflame doctors' paranoia further, something Burke says he's as concerned about as anyone is. "I worry about doctors who refuse to prescribe opioids under any circumstances because of fear. It's not a good thing for any of us as patients."
LOWERING YOUR RISK FACTOR
There's no way to eliminate the risk that you'll be duped by a drug diverter and, perhaps, come under scrutiny by law-enforcement officials. In fact, if you've never been hoodwinked, the saying goes, you're probably not practicing effective pain management.
David Brushwood, professor of pharmacy health care administration at the University of Florida, Gainesville, has come up with an approach to avoid being duped that he calls VIGIL. Here, in summary, are the five-steps he recommends (for a fuller explanation, go to www.painandthelaw.org/mayday/brushwood_071505.php):
Verification. Before prescribing Schedule II opioids or hydrocodone/acetaminophen, verify that the patient will use the drugs responsibly (do this by checking with a previous provider, for example).
Identification. Require that the patient produce a government-issued photo ID.
Generalization. Explain to patients what the general rules are—no sharing drugs, no "emergency" verbal refills when there's no emergency, and so forth.
Interpretation. Gauge whether the patient's functionality is improving (require that she keep a diary, for instance, or talk to family members).
Legalization. Stay current on state and federal laws and what they require, such as physical exam and documentation requirements.
More prevention tips are offered by John Burke, the commander of the Greater Warren County Drug Task Force, in Ohio.
Use Rx pads for prescribing only, not to write reminders or notes.
Treat Rx pads as you would your checkbook.
Record the medication, amount, and number of refills in a patient's chart.
Don't leave the refill space blank—or fail to circle the appropriate number.
Don't sign Rx blanks in advance.
Document, document, document.