Embattled doctor's attorney seeks Supreme Court relief
By Sherry Robinson
Dr. Joan Lewis has asked the state Supreme Court to take superintending
control over her hearing before the state Board of Medical Examiners.
The board has charged Lewis, an Albuquerque practitioner who
specializes in patients with severe, chronic pain, with six counts of
"injudicious prescribing." Lewis has developed a unique program using
narcotics, or opioids, that measures and tracks the severity of pain and the
effects of the drugs. Lewis's license to practice in New Mexico rests on the
outcome of the board proceedings. Groups of patients, doctors and national
organizations have filed amicus briefs in support of Lewis.
The hearing is scheduled June 20. Lewis's attorney, Frank Spring, says
he doesn't have enough information to prepare a defense because the board
and the Attorney General's Office have refused to answer questions.
Spring filed the brief June 5 after state District Judge Carol Vigil
dismissed a petition seeking appointment of another hearing officer and a
judgment that the state's Pain Relief Act governs the case. He asks the
Supreme Court to stay the hearing, appoint an independent hearing officer
and rule that the Pain Relief Act applies.
The Pain Relief Act provides that health-care providers treating
intractable pain won't be disciplined if they comply with the board's pain
relief guidelines. Lewis was a co-author of the guidelines. The board's
accusation "in all likelihood means that the board believes Dr. Lewis
administers opioid medications in higher doses than they consider prudent,"
Spring writes in the petition.
A second issue is whether Lewis can get a fair hearing because the
board, through the Attorney General's Office, has refused to respond to
reasonable requests for information, Spring says. He argues that the board's
president and hearing officer, John Romine, has been unduly influenced by
the Attorney General's Office, which has the dual role of advising the board
and prosecuting the case. This violates Lewis's right to due process, he
"If Dr. Lewis is disciplined for providing medical care, which the Pain
Relief Act would otherwise allow, then the intent of the Legislature in
enacting that enlightened law will have been frustrated, Dr. Lewis will
suffer the ignominy of a dishonor, if not a revocation, of her license to
practice medicine, and her patients will be relegated to the less
scientific, less effective care provided by physicians who are wiling to
conform to the wishes of the board rather than to those who dare to
effectively treat the needs of patients in intractable pain," Spring wrote
in the petition.
"If the old guard is allowed to humiliate a practitioner for daring to
use an empirically effective approach, then this will be a bleak message for
patients in chronic pain."
PAIN RELIEF ON TRIAL
JULY 10, 2003 - The state Board of Medical Examiners accuses the Albuquerque specialist of "injudicious prescribing" of narcotics for six pain patients. An assistant attorney general calls Lewis' practice "voodoo."
Supporters -- including patients, doctors, medical ethicists and three national organizations -- have lined up behind Lewis. Allied doctors and patient advocates insist that narcotics, or opioids, have a legitimate role in treating severe, chronic pain. Regulators like the state board, they say, are creating a climate of fear for doctors. The result is undertreatment of pain and needless suffering.
"The board action against Dr. Lewis is the beginning of denying the citizens of New Mexico adequate pain management in their time of need," says one patient's attorney, Carolyn Merchant.
This case is complicated by the behavior and tactics of the board's hearing officer and the New Mexico Attorney General's Office, which Lewis' attorney and her supporters have found alarming.
"It's an appalling situation in which Joan Lewis doesn't stand a chance of getting a fair hearing," says her attorney.
People who suffer constant, debilitating pain aren't suffering in isolation anymore. In the last 15 years, pain patients, their advocates and doctors have grown into a movement replete with organizations and Web sites. They've inspired new medical guidelines and pushed legislation intended to give doctors some latitude in treating pain aggressively.
The operative word here is "aggressively." Practitioners like Lewis use narcotic medications, often in large quantities, to relieve severe pain and say they can do this without addiction. Lewis, in fact, has devised a system that not only measures and tracks the severity of pain and the effects of the drugs but can flush out addicts ("Hurting like heck," The Tribune, Sept. 11, 2000).
After visiting Lewis' clinic last year, Dr. B. Eliot Cole of the American Academy of Pain Management described Lewis' program as "pure genius" and "brilliant."
However, these practices often clash with the war on drugs and the medical community's fear of misuse or diversion. And while many physicians have embraced the use of opioids to treat terminally ill patients, not everybody subscribes to their use for others.
"There are people who are having pain," explains Dr. Walter Forman, a nationally recognized pain practitioner at the University of New Mexico Health Sciences Center. "They're not dying. Their pain is relieved by the use of opioids. They're not going around robbing and killing. They're outstanding citizens who work in important jobs and take morphine every day. I don't know how we sell this to the public, and doctors are the public."
Bennett Cohn, director of litigation for the Attorney General's Office, sees it differently.
"The first issue is whether or not doctors like Joan Lewis, who are almost cult-like in nature, will be able to prescribe significant amounts of opioids and whether or not the nature and quantity of pills is medically excessive," says Cohn, who represents the board. "A second issue is whether or not Dr. Lewis has properly examined patients for purposes of determining alternative treatments available rather than subjecting them to significant doses of opioids."
He defines the "cult-like" doctors as "folks around the country who believe in the new theory of pain management, prescribing massive quantities of opioids."
Members of that cult, apparently, would be the Compassion in Dying Federation and the Americans for Better Care of the Dying, both national nonprofit groups supporting better end-of-life care, including improved pain care, and the American Academy of Pain Management, the largest multidisciplinary pain management organization in North America.
The three organizations, as well as Forman, signed amicus briefs supporting Lewis.
Cohn argues that Lewis "prescribes upwards of 100 (pills) a day for people. When someone says, 'I don't have any pain,' they don't, but do they know what month it is?"
Cohn says he personally has had calls from friends, family members and patients regarding Lewis treatment. The calls, he says, are part of a larger picture that includes complaints from insurance companies that object to paying for these prescriptions and from pharmacists. "It all converges to say, is this medicine or some kind of voodoo practice?"
Lewis' defenders say in amicus briefs: "It is not uncommon for physicians to be investigated for prescribing controlled substances in amounts that regulators perceive as excessive."
Says JoAnn Levitt, a Roswell doctor who supports Lewis, "I've seen some of the people she treats, and they wouldn't even be walking if it weren't for her." Levitt think critics need a better understanding of chronic pain and the effect of opioids.
A host of diseases, ranging from heart disease to complications of diabetes, can cause people severe, long-term pain.
"By the time they get to the pain clinic, they've been through physical therapy, all that they can stand; surgery, all that they can stand; all the ways of treating pain, including nonsteroidal analgesics," such as Advil and ibuprofen," Levitt says.
They're difficult patients." In HMOs, doctors don't have time to listen to patients complain," Levitt says. "That's the problem: Nobody listens to them. They get depressed. They attempt suicide. They've lost functions and social interaction. These patients never get well. They never have enough money to pay their bills. You have to see them regularly and keep track of them. It's too much trouble for most doctors. It's amazing Dr. Lewis takes the time to do that."
Levitt says narcotics can reduce the pain of 75 percent of patients so they can carry on the activities of daily living.
The most common opioids used in pain relief, such as morphine and methadone, are cheap, effective and have minor side effects. Addiction isn't an issue with pain patients, she says.
"Morphine has been used since God was a child," Levitt says. "They don't become addicts if all you're controlling is their pain."
Patients are more likely to abuse over-the-counter medicine. "They think, if one is good, 15 must be better, but aspirin can cause severe gastric bleeding," Levitt says. "Morphine doesn't cause gastric bleeding."
Side effects of opioids include constipation and sedation, but the sedation tends to be temporary, Levitt says. Other effects, such as nausea, vomiting and confusion, can be treated, she says.
As one of Lewis' patients, Ann Ryan, explained previously, "If you're in pain and you take opiates, you don't get high. There's no kick. The pain absorbs the opiates."
Says Levitt, "This is what a lot of older doctors don't understand. You don't get the euphoria of unregulated street drugs where there's no idea of what strength they are."
A second issue, Levitt says, is the traditional turf warfare among doctors.
"Certain specialties think they are the only ones qualified to treat pain," Levitt says. Surgeons, for example want to treat pain surgically. "When somebody's had three or four back surgeries and still can't walk, what are you going to tell them to do? More surgery?"
Other doctors might prefer a nerve block, "but they only last a short period of time," Levitt says. "You can't have a $1,200 epidural every five days to control your pain."
Levitt also comments that the more established medical organizations think they're the final authority on various treatments and discount newer organizations, like the American Academy of Pain Management.
Altogether, Lewis' new techniques and her treatment of pain across various specialties "is ego trampling for some people," Levitt says.
In September the state Board of Medical Examiners served a notice of contemplated action, a terse, four-page document stating that the board has sufficient evidence which, if not rebutted or explained, will justify revoking or suspending Lewis' license to practice medicine in New Mexico.
In the document, each of the six counts lists only controlled substances prescribed for unnamed patients "in quantities that exceed what was medically indicated" for stated periods.
"I have no idea what I'm accused of," Lewis says.
Lewis has heard that one patient claims the program turned him into an addict. Another had a heart attack, but the manufacturer said heart problems were unknown in connection with that drug.
The four remaining patients, chagrined at the board's action, are participating in one of two amicus briefs, along with eight more of Lewis' patients. Other participants are Dr. Aroop Mangalik, chairman of the UNM Health Sciences Center ethics committee; Joan McIver Gibson, director of the UNM Health Sciences Ethics Program; Levitt, a former member of the Board of Medical Examiners and a co-author with Lewis of the board's pain guidelines; and New Mexico pain doctors David Bennahum and Walter Forman. Robert Schwartz, a UNM law professor who follows health issues, is representing them without fee.
From amicus patients, "what comes through to me is a sense of real desperation," says Schwartz. "They will have a very hard time leading any kind of life or deciding to stay alive if they can't count on Dr. Lewis. They feel the health-care profession had little concern for them. Dr. Lewis was the first to take them seriously and provide relief."
Ethicists Mangalik and Gibson want to be sure the board conducts this case "in a way that assures doctors that their use of pain medication will be fairly reviewed," according to the brief. Gibson says she doesn't know the details of Lewis' case, but insists that professional standards should apply.
"Managing pain well is such an important mandate," Gibson says. "There is a strong body of science and experience that allows physicians and others to manage pain, and there is an ethical and moral mandate to do so."
Levitt, a former board member for 11 years, "is concerned that the board appears ready to ignore both the Pain Relief Act and the very guidelines that it issued itself in 1996," the brief says.
"In my opinion, she is very, very knowledgeable and has done a lot of good research on pain management," says Levitt, who practiced medicine for 50 years before retiring. "She documents everything she does."
Bennahum is an internist at UNM's Health Sciences Center, a national expert in pain control and founder of the medical school's ethics committee. Forman is himself a pioneer in pain treatment, involving himself in the first initiative in 1988. Both "are concerned about whether physicians who practice in this area will be accorded adequate process if the board decides to review those cases where pain medication has been prescribed. They are also concerned about the role that third-party payers might play in restricting good pain treatment practices," the brief says.
In New Mexico, undertreated pain patients aren't offered any alternatives, the two doctors say. It's cheaper for insurance companies and managed-care organizations to say no care is available. They also note that at least one complaint in Lewis' case came from a third-party payer.
As a group, participants in this brief have two concerns, says Schwartz.
"One is that Dr. Lewis is being treated unfairly. The second issue is the appearance of an arbitrary process that will make physicians really reluctant to prescribe adequate pain relief."
In a second amicus brief, three national organizations and experts argue that "patients in the United States are routinely undertreated for pain" because doctors are afraid to "invite scrutiny and sanction by the board of medical examiners."
Signers of this brief are the Compassion in Dying Federation; Americans for Better Care of the Dying; the American Academy of Pain Management; Ben Rich, associate professor of Bioethics at the University of California-Davis Medical Center, whose research focus is ethical and legal issues in pain management; Sylvia Law, a professor of law, medicine and psychiatry at New York University School of Law; and Robert Brody, chief of the Pain Consultation Clinic at San Francisco General Hospital and chairman of the Ethics Service.
"Dr. Lewis is a little unusual for us to get involved with," says Kathryn Tucker, director of legal affairs for Compassion in Dying, because Lewis treats pain patients who aren't terminally ill. The federation decided to involve itself with the case because undertreatment of pain and action against doctors is such a problem nationally, Tucker says. It's clear that in "the persecution of Dr. Lewis by the medical board, it needs to have its focus readjusted."
The Portland, Ore., group has tried to inform state medical boards about inadequate treatment in pain care.
"What we do is we defend doctors who treat pain aggressively," Tucker says. "On the flip side of the situation, we look for cases of undertreated pain. There's a huge population of patients with untreated pain that could be relieved."
When boards said they never hear complaints of undertreatment, the federation began documenting cases and helping family members file complaints. "Too often, medical boards close their eyes and fail to make physicians accountable for woeful undertreatment of their patients' pain," says Tucker.
Lewis' case, she says, "is particularly interesting and troubling because there is clear indication that the medical board doesn't intend to allow her the benefit of the state's safe harbor. It's very troubling because as an advocate of good pain care, we've worked hard to pass those laws. It's unusual and shocking."
In the last 15 years both regulators and the regulated have written dozens of guidelines and policies that open the door to aggressive pain treatment. They include the World Health Organization, the American Medical Association and the Federation of State Medical Boards.
Federal guidelines recognize that opioids are an essential part of pain management, but the American Pain Society finds no national consensus on treatment of chronic pain that isn't cancer-related. And although federal law recognizes use of opioids for intractable pain, state laws don't. Boards, according to a recent survey, rarely support long-term use of opioid use for noncancer pain.
In New Mexico, the state Board of Medical Examiners published guidelines in 1996; Joan Lewis was an advisory committee member along with JoAnn Levitt.
According to the board's guidelines, "The use of opioids in acute pain and cancer pain is well accepted. It is recognized that some dangerous (prescription) drugs and/or controlled substances are indicated for the treatment of pain and are useful for relieving and controlling other related symptoms from which patients may suffer."
However, the guidelines also state: "The quantity of pharmaceuticals prescribed and the duration of their use will be evaluated by the board on the basis of an appropriate diagnosis and treatment of a recognized medical indication."
The guidelines promised that chronic pain patients could receive medical care "without stigma or contempt for the condition," Schwartz wrote in the amicus brief, and the practitioner abiding by guidelines would be assured a safe environment. Lewis and her patients relied on these promises, he says. "The board, on the other hand, has now chosen to ignore this policy."
New Mexico has had a Pain Relief Act since 1999, based on a model developed by the American Society of Law, Medicine and Ethics, and written by Schwartz, Forman and their legal and medical students.
"The original intent was to allow physicians to prescribe some pretty harsh pain medications for people who are in insufferable pain," says Sen. Mary Jane Garcia, a Las Cruces Democrat who sponsored the act.
Garcia shouldered the bill because her sister suffers unbearable pain related to losing her kidney 24 years ago. Unable to get relief in New Mexico, she goes to Texas for treatment. "We ought to be able to have something in New Mexico like that," Garcia says.
Schwartz was on hand for legislative hearings. The only opposition came from the Board of Medical Examiners. "Pain treatment is not a problem anymore in New Mexico," testified Dr. Grant LaFarge. "Everyone gets adequate pain relief now."
Schwartz recalls: "The room got very quiet. People stopped talking and shuffling papers. One by one each member of the committee described a relative who hadn't gotten adequate (pain) treatment. That testimony passed the bill."
"The board's position was that we don't need it because we have guidelines," says G.T.S. Khalsa, the board's attorney of 15 years. And the board had never received a complaint about undertreatment.
Schwartz counters that the board opposed the Pain Relief Act and refuses to carry it out. "Now they're thumbing their nose at the Legislature and the legal system: 'There may be a law, but we don't have to follow it.'"
When Garcia learned recently about the board's action against Lewis, she told Lewis, "This can't be! The bill is to protect you from that."
Realizing that despite the law, doctors are still afraid of board action, Garcia this year tried to amend the act by giving patients the right to request or reject pain relief treatment and be advised of pain management therapies. A patient who suffered because of a doctor's failure to follow accepted guidelines could recover damages. Doctors like Lewis, who felt they were wrongly accused, would have some redress. And doctors who undertreat pain would receive mandatory education.
The bill failed, but lawmakers did pass Garcia's Pain Relief Study Memorial, which directs four health-care groups, including the board, to study pain management and report back.
"Doctors should not be afraid of going to court or to prison for trying to address pain," Garcia says. "I'm going to persist and see if I can make it better."
Despite the misgivings of Lewis' supporters, the state's Board of Medical Examiners isn't a kangaroo court.
The governor appoints its eight members (two public members and six doctors) from a list submitted by the New Mexico Medical Society.
"They're all doctors who have made names for themselves in medicine," says Levitt, a former board member. "It's a very hard-working board."
Members are "very familiar with the subject" of pain management, says Executive Director Charlotte Kinney, but they might not be experts. "Undertreatment of pain is a huge issue."
Understanding that her program might arouse concern, Lewis attempted to educate the members.
"I tried to communicate what I do, how I determine doses," Lewis says. "I wanted to let them know what I was doing." She mailed papers and invited them to her clinic.
Board members would not have visited Lewis' clinic after complaints were filed "because they end up sitting as a jury," Kinney says.
This is the process in New Mexico: The board gets several hundred complaints a year about everything from rudeness to inappropriate touching. Excessive prescribing is an infrequent complaint. The board has taken action against a half dozen doctors in the last 10 years, says Khalsa, the board's in-house attorney. Complaints can come from patients, other doctors, pharmacists or insurers.
Once filed, a complaint will prompt a committee of the board's investigator and attorney and two board members to examine patient records and submit the information to an independent expert, "the most objective people we can find and the most experienced," says Khalsa.
"They look at the record, see what the doctor has done and see what the relationship is between that and the prescription," explains Khalsa.
The committee makes a recommendation to the board; at that time the two board members involved in the investigation step aside.
"If there's a reasonable disagreement about what happened, we don't take action," Khalsa says. "We only take action if what happened is beyond any sense of doubt. What did Dr. Lewis do or not do? Everything is subject to documentation. It isn't guesswork. It isn't assumptions. It's hard work."
Action takes the form of a notice of contemplated action, a legal document that lists accusations against the doctor.
Lewis received such a notice in September. The hearing is tentatively scheduled for June 20.
The case can be heard by the entire board or a hearing officer who presides over proceedings and makes recommendations to the board. Members, who don't know the accused doctor's identity, must read the hearing transcript and the evidence before making a decision. If they decide the allegations are unfounded, the case ends. If not, they have a choice of sanctions, such as a letter of reprimand, retraining or revoking a license.
In Lewis' case, they could permit her to continue in practice but prohibit her from prescribing narcotics, Khalsa says.
Will they take into account the difference between pioneering work and a pill pusher?
"I'm sure they will," Kinney says. "She is recognized as an expert on pain, but the guidelines are clear on what you do when treating patients with chronic pain." That includes taking a history of the patient, a physical examination and a psychological evaluation.
Without knowing the details of Lewis' case, Kinney observes, "I think there's a point possibly where you don't need an expert to say you can only take so many pills a day. I'm sure there's some shades of gray -- there always are when you're talking about an educated professional. But some things can be totally unreasonable."
The state Board of Pharmacy is 180 degrees from the Board of Medical Examiners in outlook, although individual pharmacists have been hostile, tearing up prescriptions and calling pain patients "pill poppers."
"There's been a misconception among pharmacists that because a certain practitioner may be prescribing several hundred units a month, it may be improper," says Jerry Montoya, chief inspector and director of the Board of Pharmacy. "We try to educate pharmacists that quantity alone is not the issue. What we care about is that the practitioner-patient relationship is established and that what's done is in the best interests of the patient."
This board looks for suspicious behavior -- say, a patient forging prescriptions or doctor shopping, or a doctor whose "clinic," a desk and two chairs, exists to sell prescriptions.
"There is no physical examination, and the length of visit is two minutes or less," Montoya says.
"Right now we don't have a problem with Dr. Lewis," Montoya says, although he's gotten calls from concerned pharmacists about prescriptions from Lewis and several other doctors.
Pharmacists have a responsibility to verify that controlled substances support legitimate, medical purposes, and they can refuse to fill a prescription if they have doubts.
Montoya says a second problem arises if the doctor calls for a larger dose than the manufacturer recommends.
"So, many pharmacists do become concerned with that because of the responsibility and liability," he says.
Lewis and Forman have both had run-ins with pharmacists.
Years earlier, pain-relief advocates formed the Rural Hospice Network. "We've actually gone into pharmacies and educated them about who these people are and educated them about the drugs," Forman says. "That's a lot of work. And we still have a couple of pharmacies who refuse to go along with this. They're convinced addiction is the number one enemy of the world."
Lewis says some Wal-Mart pharmacists have refused to fill her pain prescriptions and have even confiscated or torn up prescriptions. Some referred to patients within earshot as pill poppers or addicts.
Lewis protested to Mike Pitzl, regional manager with Wal-Mart, that insurance coverage might designate a single pharmacy; one pharmacist's refusal could interrupt needed medication. Insulting her patients, she wrote, "exemplifies the lack of concern for the patients' well-being and points out the level of ignorance of the offending pharmacist in an area which should be an integral part of training. . ."
Pitzl says he has no problem personally with Lewis' program, but federal and state laws allow pharmacists to refuse to fill a prescription if in their judgment it's questionable.
"We can't force a pharmacist to fill a prescription," he says.
Pitzl says Lewis has tried to inform pharmacists about what she's doing, and Montoya confirms that Lewis has made presentations during the board's continuing education programs.
"The pharmacists who brought this up to me are very well aware of what she's doing," Pitzl says. "If the medical profession is scrutinizing it, we have a right to scrutinize it too. She's been very good about explaining her position, but some pharmacists are still not comfortable with the doses."
Linda Coyle is just a name to most of the attorneys involved in this case.
But the reality, the humanity, of Linda Coyle is what the case is about.
The Albuquerque woman suffers from severe, disabling and constant pain in her jaws, the result of faulty mandibular joint implants.
"Pain is something that cannot be adequately described to another person, and it is impossible for any person to feel the pain of another," Coyle's attorney wrote to her state representative. "Yet the New Mexico Board of Medical Examiners has decided, without ever meeting Ms. Coyle, that her pain management was inappropriate."
Coyle is one of six patients cited in the board's action and is also an amicus brief participant.
"From Ms. Coyle's point of view, Dr. Lewis has saved her life and is the most compassionate, empathetic and caring doctor she has ever encountered," writes attorney Carolyn Merchant. "Without the pain control provided by Dr. Lewis, Ms. Coyle would never be able to get out of bed and may not even be alive today."
Merchant says her client's case "points out the limitations of deciding the appropriateness of pain management based solely on a review of the records."
What would happen if Linda Coyle loses Lewis and her treatment program?
"She would be devastated. She's in constant, horrible pain. If you saw Linda and saw the condition she was in, you would be horrified that she could be without her pain doctor. The doctors in this state should thank their lucky stars that Dr. Lewis is here. She takes the pressure off other doctors.
"This has implications beyond this case. It's key to every one of us. Where does that leave all of us....when we're in pain too?"