THE CHILL IN THE NATION'S MEDICAL COMMUNITY

By John P. Flannery


[John P. Flannery is a former appellate law clerk, federal prosecutor, special counsel to the US Senate Judiciary and US House Judiciary Committees, now in private practice; courteous comments are welcome at [email protected]]
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1/2006 - Doctors in this nation are afraid to help patients manage pain as they are afraid that the Justice Department will have them in hand cuffs like common "drug dealers" -- just for writing prescriptions for pain medication. That's why patients are going untreated or under-treated. But there is hope.

The US Supreme Court yesterday sent the Justice Department a powerful message, told them to back off, and to stop meddling in medical care in the states - as it was none of their business.

We can only hope that the courts don't stop with yesterday's decision, as there's more that the Department's doing wrong - terribly wrong.

It all started when the voters in Oregon twice endorsed doctor-assisted suicide, by which doctors prescribed pain medications for the terminally ill. The Justice Department thought it knew better than the medical profession, pronounced an "interpretive rule" that such pain management and treatment was not "legitimate medicine", and set out to usurp the Oregon voters.

The Justice Department was eager to revoke a doctor's registration with DEA by which he could dispense medication, ready to criminalize any physician for dispensing "controlled substances" that even arguably assisted suicide. And here's the rub: it didn't matter one bit to the Justice Department that these targeted physicians had fully complied with Oregon's death with dignity law. Attorney General Janet Reno in President Clinton's Administration forbade the Justice Department or DEA from characterizing any Oregon physician's assistance to a terminally ill patient as anything other than a legitimate medical practice.

Reno asserted that to authorize DEA or the Department to make such wrong-headed judgments, treating this conduct as if it were not a legitimate medical practice, would be to "displace the states as the primary regulators of the medical profession, or to override a state's determination as to what constitutes legitimate medical practice."

Senator John Ashcroft had tried to curtail assisted suicide when he was a Senator. When he became Attorney General himself, he overruled Reno's judgment and issued the disputed directive outlawing the Oregon medical practice. A physician, a pharmacist, and some terminally ill patients from Oregon challenged the Justice Department's legal authority to interfere.

The federal trial court stopped the Justice Department dead in its tracks with an injunction, and the federal appellate court found the Ashcroft rule offensive as it altered the "usual constitutional balance between the States and the federal government" when the underlying statute, the Controlled Substances Act (CSA), authorized no such disruption.

Otherwise, the appellate court said the Controlled Substances Act targeted conventional drug abuse, and thus excluded the inexpert Attorney General from making decisions on medical policy.

In its 6-3 decision, in Gonzales v. Oregon, the Supreme Court agreed with the lower courts, and told the Justice Department that it had no authority to meddle in Oregon's statutory schema to regulate medical practice in the case of the terminally ill, not under the Controlled Substances Act, or any other legal authority.

Justice Kennedy, speaking for the majority, said "[the Justice Department] does not acquire special authority to interpret its own words when, instead of using its expertise and experience to formulate a regulation, it has elected merely to paraphrase the statutory language [of the Controlled Substances Act]."

Justice Kennedy made it crystal clear that the Attorney General "is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law"

Justice Kennedy concluded, "It would be anomalous for Congress to have so painstakingly described the Attorney General's limited authority to deregister a single physician or schedule a single drug, but to have given him, just by implication, authority to declare an entire class of activity outside 'the course of professional practice,' and therefore a criminal violation of the CSA."

Worse, Kennedy concluded, if the Attorney General were free to make medical judgments, then those he "could make [would not be] limited to physician-assisted suicide." Kennedy disapproved any such broad grant of power that might enable the Attorney General to decide "whether any particular drug may be used for any particular purpose," or "whether a physician who administers any controversial treatment could be deregistered" and prohibited from lawfully prescribing any controlled substances.

According to the Supreme Court, "Congress regulates medical practice insofar as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood" but, beyond this, "the statute manifests no intent to regulate the practice of medicine generally."

The reason is simple: the federal government must defer to the States' "great latitude under the police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons."

No Attorney General may bar a medical use that is at variance or "inconsistent" with another's "reasonable understanding of medical practice."

Thus did the Supreme Court refuse "to effect a radical shift of authority from the States to the Federal Government to define general standards of medical practice in every locality."

But that's not the end of the pain that the Department would inflict. The Justice Department has also been going into every locality in the country, trying to substitute its 'medical' judgment for that of physicians who prescribe medication to manage pain.

In the current issues of the New England Journal of Medicine, Drs. Timothy E. Quill and Diane E. Meier, caution that 'regulatory oversight [by the Justice Department] translates into a high risk of disciplinary action for prescribing opioids and other controlled substances.'

You don't have to tell this to Dr. Deborah S. Bordeaux. Dr. Bordeaux worked as a physician for less than three months at a pain clinic in South Carolina as a temporary employee, and was prosecuted by the Justice Department for four prescriptions that she wrote for 7.5 grams of pain medication, OxyContin and OxyIR, for two long-standing patients of the clinic, with extensive medical charts and medical tests going back years.

Another physician testified that Dr. Bordeaux's patients had legitimate complaints, her records were sufficient, she had prescribed ordinary doses, within the range of accepted treatments, that her patients' described conditions causing the pain that were quite believable, and her medical choices were 'appropriate.' Nevertheless, after a jury trial, Dr. Bordeaux was convicted and sentenced to 97 months in prison.

How could that happen?

It was because the Government was allowed to prove in court what she could have, should have done, medically-speaking, and, in this other context than the Department's Oregon debacle, substituted its medical judgment once again for the physician, and the Government did so with standards found nowhere in the Controlled Substances Act.

For example, the federal prosecutor asked its witness at trial, whether these prescriptions were 'medically necessary', as if the issue was whether the expense of the prescription deserved medical coverage. The trial court judge expressed his reservations that this term, 'medically necessary', had anything to do with the trial - as this term, 'medically necessary', was nowhere to be found in the Controlled Substances Act.

But the testimony was not struck and the jury had no guidance as to how they should use or disregard it.

The federal prosecutor introduced testimony about what the 'proper procedure' was - as if this were a civil negligence case. Again, there's nothing in the Controlled Substances Act that, even remotely, talks about 'proper procedure.' Again the jury heard it and the jury was not told how, if at all, they could properly use the evidence.

The federal prosecutor also introduced testimony about what was the 'best possible services' - another standard entirely irrelevant to the criminal prosecution, founded upon the Controlled Substances Act.

The Justice Department thus accomplished two things in its prosecution. It introduced its medical judgment by these terms and phrases, and did so in the form of civil practice standards that are not found in the applicable criminal statute.

As a former federal prosecutor, who prosecuted drug cases, I'm sure there are cases where there are doctors who are flat out moving drugs, without any medical pretense. But these are not the cases that concern us as abusive assertions of government power.

It is the case like Dr. Bordeaux that gives us pause that the Justice Department is substituting its medical judgment for the physician's and making the variance between the Department's conception of legitimate medicine and the practitioner's the federal crime.

The U.S. Court of Appeals for the Fourth Circuit upheld Dr. Bordeaux's conviction. That was before the Supreme Court handed down its decision yesterday.

Now that the Supreme Court has expressed itself, disfavoring the medical standards of the Justice Department, particularly those not found in the criminal code, Dr. Bordeaux may petition the Supreme Court as to whether the Supreme Court believes that the Justice Department has overstepped its authority in her case as well.

In the meantime, that chill you feel in the medical community comes from our nation's capital and, more precisely, from the Department of Justice.





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