Fisking the DEA

By Radley Balko
of the Cato Institute

May 15, 2005 - Last month, I wrote a column (here) on the DEA's anti-opioid painkiller campaign, and how it was unjustly investigating, arresting, and trying doctors using the drugs to treat chronic pain patients. The op-ed went out on the wire, and was picked up by several small newspapers, including the York Dispatch. Oddly enough, DEA administrator Karen Tandy wrote a response, which appeared a few days later.

A point-by-point refutation of Tandy follows.

Tandy writes:

In Radley Balko's April 8, 2005, article "In DEA's misguided campaign" it is the author who is misguided. The Drug Enforcement Administration has no "campaign" to target doctors. We do not police the medical profession; we leave that to state medical boards.

Patently untrue. The DEA grants licenses to doctors to distribute controlled substances, including opioids like OxyContin. As is detailed in an upcoming Cato paper by Prof. Ronald Libby, the DEA charges a fee for these licenses, and uses the proceeds to investigate doctors it believes are "diverting" prescription drugs. Doctors under investigation can then have their assets seized. And again, those proceeds fund more investigations. The agency also uses its registry of licensed dispensers to monitor the prescribing habits of doctors for signs of diversion. One U.S. Attorney said publicly that the federal government will weed bad doctors out "like the Taliban."

Further, the DEA website says it will utilize "Enforcement and Intelligence Tools" to prevent diversion.

Full text:

Coordinated operations have been initiated in field offices to target individuals and organizations involved in the diversion, illegal sale, and abuse of OxyContin. The DEA is using all available enforcement tools to disrupt these illegal operations, including interagency efforts on the federal, state, and local levels, which extend to both domestic and international arenas.

The same page says that doctors are the "primary" part of the problem. If doctors are the main source of diversion, and the DEA is using "all available enforcement tools" to "disrupt these illegal operations," that sounds quite a bit like a campaign primarily directed at doctors, doesn't it? The DEA also has a specific plan to battle the diversion of OxyContin, found here.

Finally, Ronald Fraser wrote earlier this month about some telling testimony Tandy herself gave before Congress.

In March 2004, DEA administrator Karen Tandy told Congress her drug warriors have "been successful in addressing OxyContin diversion as evidenced by a reduction in the rate of increase of OxyContin prescriptions being written and a leveling-off of OxyContin sales."

If she isn't targeting doctors, why in the world would the number of legitimate OxyContin prescriptions and sales be Tandy's measure of success in combating illegal diversion?

Rather, we target the diversion of legal drugs into the illegal market as the law requires.

That's true. And a big part of the problem is the law itself. The DEA should't be policing prescription drugs.

But the way the DEA is targeting the flow of legal drugs into the illegal market is also a huge problem. The agency is disproportionately focusing its efforts on physicians. You rarely see the DEA put out a press release celebrating the capture of someone who knocked off a pharmacy, or robbed a doctor's office. But the agency regularly boasts about the latest arrest of a doctor.

Prescription drug abuse is an exploding problem evidenced by the fact that almost one out of every ten high school seniors has abused Vicodin.

"Abuse" as defined by the DEA is overly broad, and includes all off-label use of a prescription drug (by this measure, anyone who takes Adderall or Provigil for increased concentration or productivity has "abused" the drug).

More kids may be taking prescription drugs for recreational purposes, and maybe that's not the best thing in the world, but I'd hardly call it an "exploding problem." Teens are going to experiment. Better Vicodin than heroin.

We also need to weigh the alleged problem with the costs of the potential ways of fighting it. Seems to me there's no real way to fight recreational prescription drug use without limiting access to prescription drugs by the people who need them. There will always be people who fool doctors, or legitimate patients who sell a few pills off the top, or kids who swipe Percocet from their parents' medicine cabinet. I'd argue those are problems we ought to just live with. You certainly don't solve the problem by arresting doctors who prescribe the drug, or by making the medication itself more difficult to obtain. Doing so means people who need the drug suffer, and the people who use it recreationally will merely move to something else.

Drugs are diverted a number of ways -- through pharmacy robberies, prescription forgeries, and fraudulent Internet sales.

I agree (I don't see what's wrong with letting people get their medication over the Internet, at their own risk. But that's another debate). So why is the agency spending so much of its time and resources on doctors?

Doctors are a very small part of the problem.

Yes, they are. But this is an odd concession from Tandy, and directly at odds with nearly everything else the DEA has published about drug diversion. It also strongly suggests that the agency has two sets of facts (if not more), depending on its audience.

From the DEA's own website:

Illegal acts by physicians and pharmacists are the primary sources of diverted pharmaceuticals available on the illicit market.

So which is it? Are doctors a "very small part of the problem," or are they "the primary sources of diverted pharmaceuticals available on the illicit market?"

I guess it depends on whether the agency is trumpeting its victories to Congress, or defending its tactics from critics in newspaper op-eds.

Balko's assertion that DEA arrests 200 doctors a year is blatantly wrong. Last year, DEA cases resulted in the arrest of 42 doctors -- less than one arrest for every 23,000 DEA-registered physicians.

This is a little tricky. First, Tandy misrepresents what I wrote. Here's the sentence in question:

"The high-profile arrests and prosecutions of physicians (up to 200 per year, by one estimate) have caused many doctors to under-prescribe or refuse to see new patients."

There's a difference. Doctors are being prosecuted by law enforcement at all levels of government, not just the DEA at the federal level. More on that in a moment.

But even here, the DEA is deliberately slippery. I called the agency several months ago to ask how many doctors they had investigated and arrested. I was told by two separate people -- one in the diversion office and the press office -- that the agency doesn't track those kinds of statistics anymore. Obviously it does. DEA officials apparently only release the numbers when it suits them.

The DEA can harass doctors in a number of different ways, which is why the numbers can get so confusing. Tandy may be correct in asserting that the DEA arrested just 42 doctors last year, but how many did it investigate? How many did it charge? How many faced asset forfeiture? How many settled?

Tandy wrote in USA today a while back that the agency arrested just 50 doctors in 2003. But she neglected to mention that the DEA investigated more than 700. In 2001, it investigated 850 (again, these numbers are in the forthcoming Libby paper). An investigation alone can ruin a doctor's reputation and practice. And 50 or so doctors may represent a small percentage of the total number of doctors licensed, but it represents a larger percentage of doctors who specialize in pain management. It also severely and disproportionately targets doctors who are willing to engage in the more controversial (but by all signs, more effective) high-dose method of treatment.

As noted above, the tracking problem gets compounded when you consider that the DEA also trains and works in conjunction with state and local law enforcement officials, who often then make their own arrests. These statistics aren't included in Tandy's "42." The state of Virginia alone, for example, says it investigates about one physician or pharmacist per week.

Tandy's "42" also doesn't account for doctors who are colleagues, friends, or who read about these investigations, arrests, and prosecutions in the paper, realize their livelihoods are on the line, and accordingly treat their own patients with more suspicion, underprescribe pain remedies, substitute more dangerous and less appropriate non-opioids, such as Bextra and Vioxx (some 16,000+ people die each year from this class of painkillers, vs. 200 or so at most from opioids (even by the DEA's own statistics)), or conclude pain management simply isn't worth the risk, and leave the field altogether. It also doesn't account for the number of medical students who read about the agency's high-profile arrests in the newspaper, and wisely decide to specialize in something less controversial, and less likely to end their careers. The Village Voice reported a few years ago that many medical schools are advising students to avoid pain management for that very reason.

Talk to any organization representing pain physicians (I did, including Dr. Joel Hochman, of the National Foundation for the Treatment of Pain). They'll tell you that Tandy's "42" statistic is terribly misleading. Dr. Frank Fisher, whom I've written about before, sends out daily emails to a distribution list on pain treatment issues. I'd say on average he sends two articles per week about new doctors being investigated, arrested, or tried for diversion.

Those 42 were not arrested for prescribing too much medicine. They committed egregious criminal acts such as exchanging prescriptions for sexual favors or kickbacks.

This is a deliberately sensational and outrageous accusation the DEA routinely makes when defending its persecution of doctors. To my knowledge, only three doctors have ever been accused of trading sex for prescriptions, and all three were accused by repeat drug offenders under questioning from police (presumably with a deal on the table in exchange for testimony). Two are still awaiting trial. One was acquitted. Certainly, there are some bad doctors out there. But the vast majority of those being investigated have been accused of writing too many prescriptions for too many pills, not keeping diligent enough records, or getting duped by lying patients. To say that all of them were exchanging scripts for sex or money in such a sweeping fashion is intentionally deceptive, or perhaps just strikingly self-deceptive. If Tandy's going to paint every doctor under investigation as a sex-crazed dope dealer or corrupt pusher, she ought to name the doctors she's talking about.

She won't because there aren't nearly enough of them to support such a broad generalization.

These doctors do not deserve sympathy -- far from it. No rational citizen would turn a blind eye to these doctors' criminal -- and lethal -- behavior. Balko refers to Dr. William Hurwitz, who was convicted by a jury on 50 counts of drug conspiracy, including drug trafficking that resulted in death and serious injuries.

And the jury's foreman in that case told the Washington Post he believed Hurwitz was sloppy, duped by his patients, and that -- direct quote -- "no, he wasn't running a criminal enterprise." They convicted him anyway. Basically of running a criminal enterprise. The prosecution also showed no evidence that Hurwitz got "kickback" money from the handful of his prescriptions' that found their way to the black market.

If Dr. Hurwitz's prescriptions were abused, we ought to be prosecuting the people who abused them. Instead, the DEA cuts deals with the people actually selling and abusing the drugs in return for testimony against a doctor. The agency also often continues to allow illicit drugs to penetrate the black market as it collects evidence against a targeted physician.

Hurwitz's recklessness is evidenced by his continuing to prescribe narcotics -- as much as 1,600 OxyContin pills to one patient for one day -- even knowing his patients were selling them on the street.

This is a misrepresentation of the evidence presented at Hurwtiz's trial. By all indications, Hurwitz didn't know his patients were diverting the drugs. Last December, Reason's Jacob Sullum reported:

". . . the testimony of former patients convicted of drug dealing tended to confirm his defense: that he was tricked by "predators" who always knew the right thing to say to get more drugs and who bragged about how they had won his trust. One former patient said Hurwitz's concern for his patients was his vulnerability; another recalled using makeup to cover injection marks on his arm and smoking crack before appointments so he would not seem suspiciously sleepy. All described the lies they told: complaints of unrelieved pain, reports of lost prescriptions, explanations for brushes with the law.

If there was a conspiracy, defense attorney Patrick Hallinan asked, "Why would you have to lie?" And if Hurwitz and his patient-dealers were in cahoots, why would he carefully record all the potential signs of trouble the prosecution would later cite as evidence of his "head-in-the-sand attitude"?"
Sullum concluded:

"More to the point, the jury was not supposed to determine whether Hurwitz was a good doctor; that's an issue for the state medical board. The jury was supposed to determine whether Hurwitz intentionally fed the black market in opioids. Since the evidence indicated that he prescribed in good faith, with the intent of treating pain, convicting him of drug trafficking sets a chilling precedent."

Writing in USA Today during Hurwitz's trial, Karen Tandy, head of the Drug Enforcement Administration said, "doctors acting in good faith and in accordance with established medical norms should remain confident in their ability to prescribe appropriate pain medications." Notice that "good faith" is not enough to keep the DEA at bay. Doctors also have to prescribe "in accordance with established medical norms," as determined by the DEA, and prescribe only those medications and dosages the DEA deems "appropriate."

As for that solitary prescription for 1,600 pills, Tandy uses this little nugget over and over again. At the press conference celebrating Hurwitz's conviction, for example, she held up a plastic bag filled with 1,600 pills for effect (as if Hurwitz were dispensing OxyContin in dime bags).

I've reported here that Hurwitz, a pharmacist, and an office aid all have said that particular prescription was clerical error, and that it was corrected before the prescription was filled.

But even if he had intended for that prescription to be filled, it's not nearly as outrageous as it seems. Patients on opioid therapy typically require escalating doses in the early stages of treatment. The dose can be increased with little or no side effects. Dr. Hochman, for example, says he has several patients who take 280mg of oxycodone medication three times per day, with no side effects. In fact, he says, his patients report that they only way they can tell they're even on the medication is, simply, that the pain goes away. That's 840 milligrams per day. If the dose they require from OxyContin were substituted with 10mg hydrocodone pills, the equivalent would be 126 pills per day. A 30-day prescription at that dosage would amount to 3,780 pills.

So a single prescription for 1,600 pills really isn't unreasonable at all. In fact, it would be convenient. The problem is, the DEA will no longer let patients get prescriptions that far into the future. Instead, they're required to trudge to the doctor far more frequently to get the pills in smaller quantities. Just another way the agency makes people who are hurting jump a few more hurdles.

Incidentally, Richard Paey -- the MS patient and paraplegic doing time in a Florida prison for desperately (and illegally) obtaining the pain medication he needed -- now gets morphine in his cell, paid for by the state of Florida. He gets the exact same high dosage that Tandy, the state of Florida, and like drug warriors say is unnecessary, and "proves" on its face that diversion is taking place.

High-dose treatment isn't yet universally accepted, though it's finding more and more adherents in the medical community -- even if fewer and fewer doctors are will to take the risk of actually administering it.

Here's the important question: Who do we want making this decision -- drug cops with no medical training, or doctors?

The Dr. Hurwitzes of the world need to be put out of business where they can do no further harm. It is disingenuous to suggest DEA's motives involve anything other than protecting the public.

Of course, hundreds of Dr. Hurwitz's patients have gone on record expressing their gratitude for the good he's done for them. Many said he saved their lives. They've also expressed their outrage at his conviction. But they weren't allowed to testify at his trial. Only the small percentage of bad patients were (yet another way the deck's stacked against drug war defendants).

Tandy couples Hurwitz's imprisonment and the ratio of gracious patients to criminal ones (about 5 percent of Hurwitz's patients abused his prescriptions) to conclude that he can now do "no further harm." A more accurate assessment would be that Hurwitz can no longer help the vast majority of his patients avoid excruciating pain.

This also seems like a good time to bring up the parts of my op-ed that Tandy didn't address.

• If the DEA's motives are only "to protect the public," for example, why did 30 state attorneys general "from both parties" write a letter to Tandy expressing their concern over the way the DEA has been treating doctors?
• Why did the three major medical associations representing pain specialists write a similar letter?
• Why did the five past presidents of one professional association of pain specialists write a letter protesting bald misstatements of fact at the Hurwitz trial?
• Why did David Joranson, who headed the collaborative group of pain specialists the DEA consulted to come up with its (now retracted) physician guidelines write a sharply-worded rebuke to Tandy and her agency?

Tandy can insist all she likes that her agency's actions have no effect on the "legitimate" treatment of pain. But the people actually effected by what her agency is doing -- pain doctors and pain patients -- are nearly unanimous in disagreement.

Contrary to Balko's assertion, DEA has not changed its investigative approach or its emphasis on physicians. The arrest numbers bear this out.

Again, arrest numbers are too amorphous to analyze. But there's no question the DEA has changed its investigative approach. It posted guidelines on its website that physicians could ostensibly follow to avoid investigation. It then abruptly pulled down those guidelines and renounced them, just as its most high profile target to date (Hurwitz) was on trial, and his attorneys attempted to introduce the guidelines as evidence.

The DEA came up with a set of guidelines under which it would investigate physicians, then revoked them. I'd say that a pretty clear example of "changing its investigative approach."

I couldn't agree more with Balko that pain medications are safe and effective -- when they are taken as directed by patients with legitimate need under a doctor's care. However, when these drugs get into the hands of abusers, such as those who crush and snort OxyContin pills to get high, these drugs cease being medicine and become dangerous street drugs neatly packaged in a pill.

Just how dangerous the drugs actually are even when used improperly is open to debate. Libby's forthcoming paper calls into question many of the DEA's methods of accumulating data on OxyContin deaths and overdoses. Nevertheless, we need to rethink how we approach this problem. Drug abusers will continue to abuse drugs. Make opioid painkillers more difficult to obtain, and they'll move on to something else.

Chronic pain patients don't have that option.

DEA is trying to end this abuse -- by addressing the many sources of drug diversion, including the rare doctor who is no longer healing but simply dealing for profit or pleasure. The public deserves no less from us.

Again, it's odd how the DEA asserts that abusive doctors are both "rare" and the primary source of illicit opioid painkillers. Can't be both, particulalry if illicit opioids are as pervasive as the DEA insists.

And as noted, Dr. Hurwitz may have been sloppy or kept poor records, but there are hundreds of grateful patients who will assert he was "healing." And the prosecution presented no evidence at his trial that he was "dealing" for either "profit" or "pleasure." They presented evidence only that he was tricked, duped, and otherwise hookwinked into prescribing meds for a small number of patients who then used the medication inappropriately. At most, Dr. Hurwitz is guilty of negligence. Even that's a stretch.

Finally, none of this addresses the fact that the current focus on criminal prosecutions as a strategy for reducing diversion and "harm" distracts focus and funding away from more effective ways of addressing the addictive disorders that are the actual cause of diversion and abuse. Dr. Hochman and other experts believe that if half the funding expended on investigations, prosecutions, incarceration and probations were spent on legitimate drug education for the young, and case identification and addiction treatment, OxyContin abuse (which is probably quite a bit less than the "epidemic" it's often portrayed to be) could be eradicated.

As for what the public "deserves" from the DEA, well, Jesus. It would take several books worth of words to do adequate justice to the damage that agency has done to the people it "serves." I don't have much use for the DEA at all. But if we're going to have a drug war, it oughtn't interfere with the treatment of people who are sick and suffering. It shouldn't even come close.

Radley Balko May 15, 2005