Good morning. I am Harold Sox. I am a general internist and President of the ACP-ASIM. Our organization is the nation’s largest medical specialty society with over 100,000 members who practice internal medicine and its subspecialties. The guiding principle of the ACP-ASIM is to advocate for patients, whether it is in the office or in the seat of government. Most of our members care for dying people, and they are deeply, universally concerned about this bill.
Consequently, the ACP-ASIM opposes S. 2151.

Our greatest concern is that this bill, if enacted, has the potential to seriously harm care for dying patients. Each year, 2.3 million people die. Without adequate treatment for their pain, many of them will suffer severe, unremitting, constant pain during their terminal illness. The foundation of good end of life care for these patients includes relief of pain.

The College is working hard to help ensure that patients get the pain medicine they need. We have developed a multi-faceted educational project on end-of-life care to help give internists clinical information in a usable format so they can better address their patients’ needs. Unfortunately, regardless of the efforts of organizations like ours, as noted by the Institute of Medicine last year, a significant proportion of dying patients with advanced disease experience serious pain.

Studies have shown that government regulations are one of the barriers to effective pain treatment. According to a 1998 survey done for the New York State Health Commissioner, physicians “may be concerned that aggressive pain management using controlled substances could be misconstrued as inappropriate prescribing and could lead to [disciplinary] proceedings.” The report went on to say that “the fear of possible disciplinary … actions resulting from the use of controlled substances influences physician practice in a way that impedes patient access to effective treatment.”

This concern is not unfounded. A recent report cited cases in Florida and Arkansas where physicians who prescribed large doses of controlled substances for the legitimate purpose of treating pain were disciplined without any evidence that the physicians had prescribed excessive amounts of opioids. Although these cases were eventually overturned by the courts, they create a climate of fear for physicians.

Mr. Chairman, the ACP-ASIM is concerned that this bill will add to that climate of fear. Please permit me to develop a few possible scenarios of how this bill could work in practice. Suppose a dying patient dies at home after receiving a prescription for opioids intended for pain control. Several weeks later, the physician receives a call from a DEA official, who is investigating the circumstances surrounding the patient’s death. How did the DEA know to call upon her in the first place? How would the DEA determine that there were grounds to investigate whether the cause of death was suicide, especially since the patient was terminally ill and could have died at any time? Even if there had been an autopsy, it would likely be difficult to ascertain the precise cause of death.

To answer these difficult questions, the DEA official would have to talk with the family of the deceased, question them about the patient's frame of mind, and specifically ask whether the patient had taken an overdose of narcotics. Imagine the frame of mind of the grieving family that is now a party to this investigation -- “re-living” with a government investigator the last days of a loved one’s life.

But, even if the family stated that the patient took an overdose with suicidal intent, how will the DEA decide that there is enough evidence to show that the physician knowingly providing assistance? Perhaps the DEA official will ask the grieving family. Or, they will question the physician’s colleagues, nurses, or other co-workers. Either way, the investigation will be onerous.

The DEA could also attempt to get enough evidence to confront a physician by monitoring prescriptions for opioids and investigating those physicians who had been writing large doses of narcotics for patients who died soon after the date of a prescription. This approach would be less invasive of privacy but a much less accurate way to test whether a physician provided drugs to help a patient end his life.

Physician assisted suicide is a rare event. A recent New York Times article noted that only a fraction of one percent of the 2.3 million Americans who die each year do so with help from their doctors. Only 5 dying Oregonians have asked their physician to help them to commit suicide, during a period when tens of thousands of Oregonians have died of natural causes after a painful illness that their physician helped them to endure by prescribing large doses of narcotics. Does the Congress want the DEA to investigate thousands of physicians who have not participated in a physician-assisted suicide in order to find one physician who may have helped a patient to die? That would be like subjecting thousands of patients to an inaccurate screening test and then requiring a major operation to be sure a patient with a positive test really has the disease.

Identifying physicians by analyzing prescribing patterns is also problematic because it would subject those physicians who have the most seriously ill patients, or those physicians who are recognized as being experts in pain management, to increased scrutiny. Ironically, these are the physicians that patients turn to when they face a terminal and painful illness.

For a health professional, an accusation of assisting a patient’s suicide is very serious and could place her professional standing under a permanent cloud. Under S. 2151, a physician who sent a patient home with a large prescription for narcotics will have to defend themselves in a DEA investigation. Although language in the House version of the bill was added to raise the government’s burden of proof to showing “clear and convincing” evidence of the physician’s intent, the very fact of a government investigation will damage a physician’s reputation even if the government cannot meet this standard of proof. It doesn’t take more than one or two investigations to convince others in the medical community to err on the side of under use of opioids to treat pain. Even if a physician is ultimately exonerated, the damage will have been done.

Mr. Chairman, if S. 2151 became law, it would either intrude on the privacy of grieving families and set them against the loved one's physician, or it would call thousands of physicians to account in order to detect a tiny minority. Thus, the law would either be virtually unenforceable or cause a great deal of harm for questionable benefit.

Mr. Chairman, how to care for patients at the end of life is complex and controversial. There are clearly conflicts of opinions about the impact of this bill on the care of dying patients. Consequently, before enacting legislation such as S. 2151, the College urges that the Congress pass legislation authorizing a study to examine the relevant end-of-life care issues such as: how to properly treat pain; current prescribing practices of physicians; incidences of patient suicides; and how to protect patients’ privacy. I would note that S. 2330, The Patients’ Bill of Rights Act, sponsored by the Republican leadership, calls on the newly named Agency for Healthcare Quality Research to study end of life care.

In sum, under the threat of being denied registration under the Controlled Substances Act, many physicians will avoid prescribing large doses of narcotics to relieve pain in dying patients, lest they invite the attention of the DEA to themselves and the families of the deceased. In addition, the procedure envisioned by the bill threatens patients' right to privacy, since the review process will require physicians to disclose details of patient care that should be held in confidence.

Rather than moving quickly in this complex and controversial area, the College recommends that Congress authorize a study to examine the myriad of end-of-life care issues.

Thank you. I’ll be happy to answer any questions Committee members may have.