The problem is pain. Patients and their families tell the story:

He is your son. You love him. You want to help him in every way you can, but when he is in that kind of pain, you are helpless in a sense. Im his daddy. It was-what was I supposed to do for him? I felt, you know, helpless.

It terrifies you. You want to run away from it. Pain is something you wish would kill you but does not. Agony results from the pain that does not have the decency to knock you out.

[W]e had a good family, but how much can you watch? How much suffering can you watch from your child, your 7-year-old child, and still keep your mind?

I am a forty-six-year-old registered nurse who specializes in oncology care and education. I am also a patient who suffers from chronic nonmalignant pain, and this malady has been the most frightening, the most humiliating, and the most difficult ordeal of my life .

In Campbell Soup Co. v. Allstate Insurance Co. (913 F. Supp. 451 (W.D. Mich. Jan. 9, 1996)), the United States District Court for the Western District of Michigan, Southern Division, held that a health plan's coordination of benefits (COB) clause, covered under the Employee Retirement Income Security Act (ERISA), does not preempt a similar no-fault automobile insurance clause in the absence of irreconcilable conflict. The court found that ERISA's policy of shielding plans from unanticipated claims could only be furthered when the plan had expressly disavowed such claims. Because the ERISA plan in this case did not specifically subordinate itself to the no-fault policy, the district court found that the no-fault COB clause controlled. However, to escape this ruling, ERISA plans need only redraft their COB clauses specifically to disclaim liability in case of conflict with provisions of no-fault insurance policies. This caveat substantially limits the scope of the court's ruling.

The debate about the definition of scientific miscon duct is being revisited by the scientific community in response to the Commission on Research Integrity's (CRI) recommendation for a new definition. Scientists and lawyers are debating whether scientific misconduct should include acts that are not unique to the scientific community and do not affect the research. Falsification of credentials is one form of such misconduct.

The Office of Research Integrity (ORI) and the National Science Foundation (NSF), the two federal agencies primarily responsible for developing policies on scientific misconduct, have struggled to define scientific rnisconduct and to decide which forms of professional misconduct do and do not fall within the definition. Although falsification of credentials is not unique to the scientific community, OR1 and NSF have determined that when researchers lie about their credentials, such conduct may constitute scientific misconduct. The question is why this form of professional misconduct has been labeled scientific misconduct when it occurs in a research setting, and whether any distinction exists between this white coat crime and white collar crime.

My purpose is to provide an update on recent Texas regulatory and statutory changes adopted , since the passage in Texas of the Intractable Pain Treatment Act in 1989 (Pain Act) (see Table l). First, I describe the rules adopted by the Texas State Board of Medical Examiners (TSBME) that authorize physicians to prescribe opioids for the treatment of pain (Pain Rules) (see Table 2). Second, I detail recent statutory changes that pertain to education of physicians and medical students about pain treatment. All of these changes attempt to create a better legal environment for the treatment of chronic pain in Texas.

Before describing the Pain Rules adopted in Texas, the question Why adopt rules, rather than simply ask TSBME to issue a policy statement? must be answered. Many states, most notably California, have issued policy statements that clarify for physicians the parameters within which they may treat pain? Policy statements, unlike administrative regulations, do not have the force of law.

The current debate about physician-assisted suicide and the question of whether patients would ask for such help if their pain were adequately controlled place in sharp focus the issue of undertreated pain. Studies have repeatedly documented the scope of the problem. A 1993 study of 897 physicians caring for cancer patients found that 86 percent of the physicians reported that most patients with cancer are undermedicated for their pain. A 1994 study found that noncancer patients receive even less adequate pain treatment than patients with cancer-related pain, and that minority patients, the elderly, and women were more likely than others to receive inadequate pain treatment. Although the problem of undertreatment of pain is multifaceted, I only address how state medical boards contribute to the problem and suggest possible remedies.

The literature on palliative care describes the numerous barriers that impede effective pain management and that result in the inadequate prescribing of pain-relieving drugs for terminally and chronically ill patients.

Physician concern about regulatory scrutiny as a barrier to appropriate prescribing for pain management has been identified and studied. A 1991 Pain Research Group survey demonstrated a need to provide updated information about opioids and pain management to state medical board members. Indeed, a national survey even showed a need to provide more education about pain management to oncology Physicians. Two approaches for responding to these concerns have been undertaken in several states by the state medical boards and the pain management community: the development and adoption of administrative policies designed to bring disciplinary standards in line with clinical practice; and the creation of education programs for state medical board members and staffs. Each can have a substantial impact on removing real and perceived regulatory barriers to effective pain relief.

In St. Francis Regional Medical Center v. Blue Cross & Blue Shield of Kansas (49 F.3d 1460 (1995)), the United States Court of Appeals for the Tenth Circuit upheld Blue Cross/Blue Shield of Kansas's anti-assignment requirement, on the grounds that the Employee Retirement Income Security Act (ERISA) preempted a hospital's claim against Blue Cross. The court also held that public policy supported anti-assignment requirements in health plans not covered under ERISA.

When drafting ERISA, Congress did not explicitly address assignability of health care benefits. According to the court of appeals, congressional silence constituted an intent to allow the parties to negotiate freely the assignment of health care benefits. Examining non-ERISA health plans, the court adopted a balancing test to determine the validity of anti-assignment clauses; it found that anti-assignment requirements promote freedom of contract and may include medical costs.

The United States District Court of Kansas, in Gudenkauf v. Stauffer, Znc.(922 F. Supp. 465 (D. Kan. 1996), granted the defendants motion for summary judgment for the plaintiff's claims of pregnancy-related discrimination under the Americans with Disabilities Act (ADA) and the Family and Medical Leave Act of 1993 (FMLA), but the court denied a similar motion for the plaintiff's claim under the Pregnancy Discrimination Act (PDA). The court found summary judgment to be appropriate for the ADA claim based on its finding that the plaintiff's pregnancy did not constitute an impairment as required by the statute; as for the FMLA claim, it determined that the defendants failure to grant the plaintiff's leave request did not violate the statute. However, the court determined that summary judgment was inappropriate for the PDA claim because of material questions of fact about whether the defendant had acted with discriminatory intent.

In considering the motions for summary judgment, the court accepted the following facts as incontrovertible. Plaintiff Michaela Gudenkauf worked for the defendant Stauffer, Inc.

In Martin v. Ortho Pharmacetrtical Corp. (No. 78520,1996 Ill. LEXIS 5 (Jan. 18, 1996)), the Supreme Court of Illinois held that, although a federal regulation requires pharmaceutical manufacturers to provide direct warnings to consumers about the dangers associated with oral contraceptives, this regulation does not constitute an exception to the learned intermediary doctrine and the manufacture will not be held strictly liable. The court declined to recognize an exception for manufacturers of contraceptives due to important policy considerations and the legislative intent underlying the learned intermediary doctrine. The doctrine is based on the assumption that prescribing physicians, not pharmaceutical manufacturers, are in the best position to provide direct warnings to patients concerning the dangers associated with prescription drugs. The decision may affect patients whose medical care providers are unable to account for drug propensities or patient susceptibilities. Additionally, patients with forgetful or inarticulate health care providers are at risk.

As medical technology becomes more sophisticate the ability to manipulate nature and manage disease forces the dilemma of when can becomes ought. Indeed, most bioethical discourse is framed in terms of balancing the values and interests and the benefits and burdens that inform principled decisions about how, when, and whether interventions should occur. Yet, despite advances in science and technology, one caregiver mandate remains as constant and compelling as it was for the earliest shaman—the relief of pain. Even when cure is impossible, the physician's duty of care includes palliation. Moreover, the centrality of this obligation is both unquestioned and universal, transcending time and cultural boundaries.

Although universally acknowledged, pain is a complex phenomenon for both the patient and the caregiver, influenced as much by personal values and cultural traditions as by physiological injury and disease.

Recent studies have exposed the startling inadequacy of health care providers knowledge about and practice of effective pain management. For example, in one study, it was reported that 79 percent of a random sample of 454 medical-surgical inpatients experienced pain during hospitalization, and that 58 percent of patients with pain considered the pain horrible or excruciating. In another study, 67 percent of 2,415 randomly selected hospitalized patients had pain during the twenty-four hours prior to being interviewed, and 50 percent reported pain at the time of the interview. In a study of seriously ill hospitalized patients reported in 1996, half of the patients complained of pain, and one-sixth reported that they experienced extremely severe pain at least half the time. According to one literature review, 75 percent of cancer patients have reported suffering pain, and one study estimates that 25 percent of cancer patients die with severe unrelieved pain. Chronic nonmalignant pain has been described as an extremely prevalent problem, and over two-thirds of nursing home residents experience serious pain.

The United Court of Appeals for the Eleventh Circuit, in Amstrong v. Flow ersffospital, Lnc. (33 F.3d 1308 (11th Cir. 1994)), held that a hospital's termination of a pregnant employee for refusal to treat an HIV-positive patient did not violate the Pregnancy Discrimination Act (PDA), based on either the disparate treatment or the disparate impact theory. As an employer, a hospital is not required to make policies specifically addressing the needs of pregnant employees and is not to be held liable for discrimination absent a showing of differential treatment based on the facial intent of employer policies or on actual impact through policy application. Hence, although women cannot be forced to decide between employment and pregnancy, they will not be afforded special treatment based on their pregnancy.

Pamela Armstrong worked for Southeast Alabama Medical Center (SAMC). After one year, Armstrong took a position with the Home Care Services (HCS) division of Flowers Hospital.

The Indiana Court of Appeals, in JKB, Sr. v. Armour Pharmaceutical Co. (No. 49A029506CV341, 1996 WL 22708 (Ind. Ct. App. Jan. 24, 1996)), held that the state's Blood Shield Act does not protect pharmaceutical companies that produce blood-derived products from product liability suits based on injuries attributable to tainted blood supplies. Blood shield statutes help to guarantee adequate blood supplies by limiting the liability of blood banks. This holding limits the defenses available to pharmaceutical companies sued under product liability theory.

The defendant, Armour Pharmaceutical, produces and sells clotting factor agents, which are derived through plasmapheresis. Plasmapheresis is a costly and complex donation process through which the plasma and red blood cells of a donor's blood are separated. After separation, the process returns the red blood cells to the donor but retains the plasma.

In Planned Parenthood Affiliates of Michigan v. Engler (73 F.3d 634 (6th Cir. 1996)), the United States Court of Appeals for the Second Circuit held that § 400.109(a) of the Social Welfare Act of Michigan (Mich. Comp. Laws Ann. § 400.109(a) (1994)) impermissibly conflicts with the Medicaid Act (Social Security Act tit. XIX, 42 U.S.C. §§ 1396 et seq. (1988)) as modified by the 1994 Hyde Amendment (Pub. L. No. 103-112, § 509, 107 Stat. 1082-1113 (1994)), insofar as the § 400.109(a) only provides state funding for abortions necessary to save the life of a mother, and not for abortions resulting from rape or incest. The court held that the Hyde Amendment defines medically necessary abortions that must be funded by states participating in the federal Medicaid program, and that the amendment is not merely a federal appropriations bill.