Hawley v. Evans

716 F. Supp. 601, 1989 WL 73918

• Court: District Court, N.D. Georgia
• Decided: July 5, 1989
• Docket: 1:88-CV-2185-CAM
• Status: Published

Opinion

ORDER

MOYE, Senior District Judge.

The above-styled action is brought by three prisoners in the Georgia Corrective System who have tested positive for antibodies to the Human Immunodeficiency Virus (hereafter “HIV”) which is the precursor to the Acquired Immune Deficiency Syndrome (hereafter “AIDS”). Said action is before this court on cross motions for summary judgment, the plaintiffs’ motion for clarification, the plaintiffs’ motion to compel discovery, the plaintiffs’ motion for reconsideration of this court’s order dated April 25, 1989, and the defendants’ motion to transfer plaintiffs Hawley and Mitchell from the Augusta Correctional and Medical Institution. For the reasons stated below, the defendants’ motion for summary judgment is GRANTED, the defendants’ motion to transfer plaintiffs Hawley and Mitchell is GRANTED, the plaintiffs’ motion for summary judgment is DENIED, the plaintiffs’ motion for clarification is DENIED, the plaintiffs’ motion to compel is DENIED and the plaintiffs’ motion for reconsideration is DENIED. 1

FACTS

The plaintiffs in this action are prisoners in the Georgia Prison System. All three have tested HIV positive. However, plaintiff Mitchell is in a more advanced degree of sickness. The main thrust of the plaintiffs’ complaint is a prayer for injunctive relief. They are requesting adequate and up-to-date treatment from the Georgia Department of Corrections, or, in the alternative, the right to be seen by a private physician of their own selection. They are also requesting damages, alleging that the defendants have committed acts and omissions amounting to that deliberate indifference to serious medical needs constituting cruel and unusual punishment under the Eighth Amendment.

The plaintiffs are requesting a wide variety of drugs and medical treatments, many of which are experimental and have not been approved by the Food and Drug Administration (hereafter “FDA”), claiming they have the constitutional right to such treatment either through the prison medical facilities or under the care of private physicians of their own selection. The plaintiffs claim they are financially able to employ such private physicians.

One drug that the plaintiffs are requesting, which was initially denied them by the prison authorities, is Zidovudine, more commonly known as “AZT”. AZT has been approved by the FDA and is the only antiviral agent that has been clearly shown to improve immune function in AIDS patients (see attachment “E”). Its availability to the plaintiffs is therefore of central importance to this law suit.

The attitude in the scientific community towards AZT is one of uncertainty. Experts disagree about who should receive the drug, at what stage patients should be treated with it, and proper doseage. This court has received materials that delineate the policies of the Center for Disease Control (hereafter “CDC”), the Georgia Department of Human Resources (hereafter “GDHR”), and the FDA (see attachments “A” through “G”, the plaintiffs’ motion for summary judgment, and the defendants’ supplement to cross motion for summary judgment). There are two things that one can safely conclude about the literature received: 1) the policy for administering AZT and other treatment for HIV and AIDS patients changes frequently and as yet no one in the medical community is sure of what is protocol; and 2) AZT can be highly toxic to some patients and should be used conservatively, if at all.

The Georgia Department of Corrections has a uniform policy under which it currently administers AZT to patients that have symptomatic HIV infection and have an absolute CD4 lymphocyte count of less than 200/mm3 in the peripheral blood, and to patients with a history of cytologically confirmed pneumocystis carinii pneumonia and an absolute CD4 lymphocyte count of less than 200/mm3 in the peripheral blood. The plaintiffs have not disputed that the above is indeed the uniform policy of the Georgia Department of Corrections. At the court’s request, not order, the plaintiffs were transferred to Augusta Correctional Medical Institution for testing and were offered treatment with AZT, even though the patients had not met the state standard mentioned above. Two of the patients refused such treatment, one accepted.

The Georgia Department of Correction’s AZT policy is not significantly dissimilar to the standards of the FDA, the CDC and the GDHR. There are some differences, for instance, in the interpretation of the word “symptomatic” (compare attachments “F” and “G”). However, such differences are to be expected because, as already mentioned, what is acceptable with AZT treatment is not immutable, but rather some thing that is indeterminate and ever-changing.

LEGAL DISCUSSION

1. The Georgia Department of Correction’s medical policy for HIV patients

To state a claim of constitutional magnitude for the denial of medical care and treatment, the plaintiffs must show that the defendants were deliberately indifferent to their serious medical needs. Estelle v. Gamble, 429 U.S. 97, 105, 97 S.Ct. 285, 291, 50 L.Ed.2d 251, 260 (1976). In light of the facts of the instant case, it can hardly be said that the Georgia Department of Corrections has been “deliberately indifferent” to the serious medical needs of the plaintiffs. Its policy for treatment of HIV positive patients is similar to that of other reputable national and local agencies. Although its policy differs in some ways from the standards of other reputable agencies, the court in this case is not empowered to delve into the particulars and intricacies of modern medicine or to make narrow distinctions on debatable interpretations of what should be acceptable in the medical community. This court’s powers are not enlarged by reason of the growing public awareness of the impact of AIDS on the national community. What this court can and must decide is whether the Department of Correction’s medical policy is constitutionally acceptable. In the judgment of this court the applicable medical policy substantially conforms to currently acceptable medical practice. Therefore the plaintiffs do not state a claim of constitutional magnitude.

Far from their actions being “repugnant to the conscience of mankind” pursuant to the Estelle v. Gamble standard, the defendants have demonstrated they are willing to pursue the modern medical practice relating to the treatment of HIV patients consistent with their roles as custodians of unwilling prisoners. The medical care provided a prisoner is not required to be “perfect, the best obtainable, or even very good.” Brown v. Beck, 481 F.Supp. 723, 726 (S.D.Ga.1980). The Supreme Court in Estelle v. Gamble specifically states that not “every claim by a prisoner that he has not received adequate medical treatment states a violation of the Eighth Amendment”. 429 U.S. at 105, 97 S.Ct. at 291. Clearly, negligence is not enough. 2 Negligence, without deliberately indifferent or wanton conduct, is not cruel and unusual punishment. Negligence by a prison medical officer may constitute actionable medical malpractice. 429 U.S. at 108, 97 S.Ct. at 293. However, that is not the nature of this law suit.

2. The plaintiffs’ right to employ at their own expense a private physician and the plaintiffs’ right to experimental drugs for the treatment of the virus

The plaintiffs are also asserting the right to: 1) a private physician; and 2) through and by that physician (or, in the alternative, through and by the medical facilities at the Georgia Department of Corrections) experimental and novel forms of treatment of which there appears to be some evidence of remedial, or at least ther-apeutical, value. This court holds that the plaintiffs are not entitled, as a matter of constitutional right, to either.

The treatment of patients in prison is “traditionally the exclusive prerogative of the state”. Ort v. Pinchback, 786 F.2d 1105 (11th Cir.1986); Morrison v. Washington County, Ala., 700 F.2d 678 (11th Cir.1983). Some states have statutes allowing prisoners to bring in private physicians. Georgia does not have such a statute—nor is Georgia constitutionally required to have such a statute. This court holds that reasonably restricting visits from private physicians is reasonably related to the legitimate concerns of institutional security. Newman v. State of Alabama, 559 F.2d 283 (5th Cir.1977) modified, 438 U.S. 781, 98 S.Ct. 3057, 57 L.Ed.2d 1114 (1978) cert. denied, 438 U.S. 915, 98 S.Ct. 3144, 57 L.Ed.2d 1160 (1978) (Prison visitation regulations should be left to prison authorities, widely adapted to individual circumstances.) This does not mean that a prison may restrict access to a private physician in all circumstances. However, as long as Georgia’s prison system is providing adequate medical care, the issue of whether or not to permit a prisoner to hire a private physician remains the “exclusive prerogative” of the state of Georgia. Inmates of Allegheny County Jail v. Pierce, 612 F.2d 754, 762 (3rd Cir.1979) (Where prison authorities prevent an inmate from receiving recommended treatment for serious medical needs, or deny access to a physician capable of evaluating need for such recommended treatment, constitutional standards have been violated.); West v. Keve, 571 F.2d 158 (3rd Cir.1978).

The same can be said for the experimental drugs the plaintiffs are requesting. As long as Georgia’s prison system is abiding by reasonable medical practices, the issue of whether to permit a prisoner to be treated with experimental drugs (many of which have not been approved by the FDA) is the “exclusive prerogative” of the state of Georgia. Moreover, jail authorities have a legitimate security concern in limiting the exposure of inmates to drugs. 612 F.2d at 761. It should also be noted that a prisoner’s claim of inadequate medical treatment which reflects a mere disagreement with prison authorities over proper medical treatment, which is exactly the case at hand, does not state a claim of constitutional magnitude. Ferranti v. Moran, 618 F.2d 888 (1st Cir.1980); Massey v. Hutto, 545 F.2d 45 (8th Cir.1976).

CONCLUSION

This court holds that pursuant to Fed.R. Civ.P. 56(c) there are no genuine issues of material fact in the instant case. Therefore, as a matter of law, this court holds that the defendants’ motion for summary judgment is GRANTED and the plaintiffs’ motion for summary judgment is DENIED. As a result, the plaintiffs’ motion for clarification, the plaintiffs’ motion to compel, and the plaintiffs’ motion for reconsideration are DENIED as this order has rendered said motions moot. Likewise, the defendants’ motion to transfer plaintiffs Hawley and Mitchell from the Augusta Correctional and Medical Institution is GRANTED.

The clerk is directed to enter judgment against the plaintiffs and for the defendants. There is no award of costs in this action.

SO ORDERED.

ATTACHMENT A

U.S. Department of Justice

Federal Bureau of Prisons

Washington, DC 20534

April 17, 1989

Honorable Charles A. Moye, Jr. Chief Judge

United States District Court

Northern District of Georgia 2142 U.S. Courthouse

Atlanta, Georgia 30303

Attn: Stephen L. Cole, Law Clerk

Dear Judge Moye:

In response to your inquiries concerning monitoring, treating, and immunizing inmates who are positive for antibodies to the Human Immunodeficiency Virus (HIV), the following information is offered.

The Federal Bureau of Prisons has established a policy that requires HIV antibody positive inmates to be evaluated by a physician at least once each month. These evaluations may or may not include a determination of T-4 count. The decision to monitor T-4 counts is a clinical decision made by the attending physician. Discussions with my colleagues have revealed that T-4 counts may generally be monitored every three to six months.

AZT treatments are provided at nearly all of our institutions. The decision to initiate AZT treatment is, again, a clinical decision. All Bureau of Prison physicians must, however, adhere to the treatment indications for AZT as outlined by the Food and Drug Administration. The FDA recommends the use of AZT:

“for the management of certain adult patients with symptomatic HIV infection (AIDS and advanced ARC) who have a history of cytologically confirmed Pneu-mocystis carinii pneumonia (PCP) or an absolute CD4 (T-4 helper/inducer) lymphocyte count of less than 200/mm3 in the peripheral blood.”

The Centers for Disease Control has been consulted with regard to immunizing HIV antibody positive patients. The following is a summary of their recommendations.

Immunization Asymptomatic patient Symptomatic patient

DTP yes yes

OPV no no

IPV yes yes

MMR yes yes

HbCV yes yes

Pneumococcal yes yes

Influenza no yes

Hepatitis B yes yes

PPD yes yes

The Federal Bureau of Prisons strives to follow guidelines established by CDC in rendering care to inmates. The above guidelines, however, are not established within the written policies of the Bureau of Prisons. The only reference to immunization of HIV antibody positive inmates concerns pregnant females and states in the Health Services Manual:

Pursuant to current immunization guidelines and unless medically contraindicated, all sentenced female inmates of childbearing age (50 and below unless medically incapable of childbearing) should be offered and encouraged vaccination against measles, mumps, and rubella. Medical contraindications include existing pregnancy (perform pregnancy test if there is any doubt) or planned pregnancy within three months. All inmates who are to receive this live virus immunization, shall be tested for HIV antibodies prior to immunization. Those who are HIV antibody positive shall not receive the live virus immunization. Those immunized should be cautioned against becoming pregnant during the ensuing three months. Prior episodes of one or more of the three diseases does not constitute a contraindication.

If you have additional questions or concerns, please do not hesitate contacting me.

Sincerely,

(s) [Signature]

Kenneth P. Moritsugu, M.D., M.P.H.

Assistant Surgeon General

Medical Director

222 MMWR April 7,1989

ACIP: General Recommendations - Continued

FEBRILE ILLNESS

The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of symptoms and on the etiology of the disease.

Although a moderate or severe febrile illness is reason to postpone immunizations, minor illnesses such as mild upper-respiratory infections (URI) with or without low-grade fever are not contraindications for vaccination. In persons whose compliance with medical care cannot be assured, it is particularly important to take every opportunity to provide appropriate vaccinations.

Children with moderate or severe febrile illnesses can be vaccinated as soon as the child has recovered. This precaution to wait avoids superimposing adverse effects of the vaccine on the underlying illness or mistakenly attributing a manifestatipn of the underlying illness to the vaccine.

Routine physical examinations or measuring temperatures are not prerequisites for vaccinating infants and children who appear to be in good health. Asking the parent or guardian if the child is ill, postponing vaccination in those with moderate or severe febrile illnesses, and immunizing those without contraindications to vaccination are appropriate procedures in childhood immunization programs.

VACCINATION DURING PREGNANCY

Because of a theoretical risk to the developing fetus, pregnant women or women likely to become pregnant within 3 months after vaccination should not be given live, attenuated-virus vaccines. With some of these vaccines-particularly rubella, measles, and mumps — pregnancy is a contraindication. Both yellow fever vaccine and OPV, however, can be given to pregnant women who are at substantial risk of exposure to natural infection. When a vaccine is to be given during pregnancy, waiting until the second or third trimester is a reasonable precaution to minimize concern over teratogenicity. Although there are theoretical risks, there is no evidence

TABLE 7. Recommendations for routine immunization of HiV-infected children - United States

Known HIV infection

Vaccine Asymptomatic Symptomatic

DTP* Yes Yes

OPV† No NO

IPV§ Yes Yes

MMR£ Yes Yes**

HbCV†† Yes Yes

Influenza No §§ Yes

*DTP= Diphtheria and Tetanus Toxoids and Pertussis Vaccine, Adsorbed. DTP may be used up to the seventh birthday.

† OPV = Poliovirus Vaccine Live Oral, Trivalent: contains poliovirus types 1, 2, and 3.

§ IPV = Poliovirus Vaccine Inactivated: contains poliovirus types 1, 2, and 3.

£ MMR = Measles, Mumps, and Rubella Virus Vaccine, Live.

**Should be considered.

†† HbCV = Vaccine composed of Haemophilus influenzae b polysaccharide antigen conjugated to a protein carrier.

§§ Not contraindicated.

HAWLEY v. EVANS 607

Cite as 716 F.Supp. 601 (N.D.Ga. 1989)

ATTACHMENT B

DECLARATION OF KENNETH P.

MORITSUGU, M.D., M.P.H.

Comes now Kenneth P. Moritsugu, M.D., M.P.H. and on his oath states:

1. I am the Medical Director of the Federal Bureau of Prisons and an Assistant Surgeon General of the U.S. Public Health Service.

2. I am responsible for the development and implementation of the HIV policy for the Bureau of Prisons. This policy provides basic guidelines regarding HIV testing, treatment, and education. Policy revisions are often necessary in light of frequent developments in the care and treatment of HIV infected individuals. Moreover, the varied aspects of treatment are also undergoing continual change, which our policy reflects. Therefore, our policy does not offer the most current or exhaustive information regarding HIV testing, treatment or education.

3. Attached is a true copy of the Bureau of Prisons’ Operations Memorandum, 99-88 (6100), Human Immunodeficiency Virus. *

I declare under penalty of perjury pursuant to 28 U.S.C. § 1746 that the foregoing is true and correct. Executed on March 29, 1989.

(s) Kenneth P, Moritsugu

ATTACHMENT C

Georgia Department of Human Resources

878 Peachtree Street, N.E.

Atlanta, Georgia 30309

April 5, 1989

The Honorable Charles A. Moye

2342 United States District Court House

75 Spring Street

Attention: Steve Cole

‘Editor's Note: Operations Memorandum not

Persons with Human Immunodeficiency Virus (HIV) infection vary from being completely well to very ill. The usual course is one to ten plus years of asymptomatic disease (average 8 years), during which the person tests positive for antibodies to the virus and can transmit the disease to others by sexual intercourse, blood injections or from mother to child. Eventually illness begins and when full blown AIDS (as defined by the Centers for Disease Control) is present, average life expectancy is approximately 18 months.

The infection progresses to illness with great variability. The current medical approach emphasizes early diagnosis and treatment even before symptoms appear.

In general, all persons who are HIV positive should have a baseline medical evaluation consisting of a complete history and physical examination and certain laboratory tests (see enclosed materials) including a CD4(T4) lymphocyte count. If these procedures show no evidence of illness or immune deficiency, these studies should be repeated at 6-12 month intervals. The person should be extensively counseled at this initial visit and subsequently as to the nature of his or her illness, methods of transmission to others, and the importance of a healthy life-style in preventing progression of the infection.

At the present time there is only one FDA approved drug active against the HIV virus, this is called Zidovudine or AZT (trade name Retrovir). The average monthly cost of treating with Zidovudine is $600-800 per month for the drug plus blood tests and clinical evaluation every two weeks.

At this time the official indications for administering Zidovudine are “for the management of certain adult patients with symptomatic HIV infection (AIDS and advanced ARC) who have a history of cyto-logically confirmed Pneumocystis carinii pneumonia (PCP) or an absolute CD4 (T4

submitted by the Court for publication.

608

716 FEDERAL SUPPLEMENT

ATTACHMENT C—Continued helper/inducer) lymphocyte count of less than 200/mm3 in the peripheral blood before therapy is begun.”

In practice, the great majority of infectious disease specialist in Georgia are beginning Zidovudine (AZT) in any patient, symptomatic or not, whose CD4 cell count is less than 200/mm3 in the blood.

Enclosed are clinical guidelines published jointly by the Medical Association of Georgia and the Georgia Department of Human Resources that discuss the former in more

* Editors Note: Clinical guidelines not submitted

detail. * Also enclosed are the FDA approved product information about Zidovu-dine.

Please call me if I can be of further assistance.

(s) Joseph A. Wilber Jospeh A. Wilber, M.D.

Medical Consultant Office of Infectious Disease AIDS Program

JAW:cga

Enclosures

by the Court for publication.

793

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for pOMibl* revisions Product Information 795 Pretreatment CD4 (T4) Level# ¡S 200/mm3 > 200/mm3 Ataormaiity % Decrease Baseline Zidovudine (n« 113) Placebo (ns 105) Zidovudine Placebo (ns 30) (ns 30) Granulocytopenia Anemia >25% Jfcrvous? anxiety, confusion, depression, emotional lability, nervousness, syncope, loes of mental acuity, vertigo, fiaptrotory? cough, epistaxis, pharyngitis, rhinitis, sinusitis, hoarseness. SUk acne, pruritus, urticaria. Special wnser amblyopia, hearing loss, photophobia. Urpgmitafc dysuria, polyuria, urinary frequency, urinary hesitancy. Ibsrt have been reports of seizures associated with the use of sidovudine, particularly in patients with more advanced OVKBDOSAGE Ooe patient who Ingested 10 to 20 grams { — 110 to 220 cy/Jv) of zidovudine as part of an intentional multidrug cmrdoss (which also included triazolam and barbiturates) experienced mild ataxia acutely but exhibited no hematologic abnormalities on extended follow-up. If overdoeage occurs, intensive obeervation for marrow suppression with transfusions and protective measures for granulocytopenia may be needed until marrow function returns. Although other nucleoside analogues have been partially removed by peritoneal dialysis or hemodialysis, it is not known whether zidovudine can be removed in this manner. DOSAGE AND ADMINISTRATION The recommended starting doee of Retrovir is 200 mg (two 100 mg capsules) administered orally every four hours around ths clock. In a 70 kg patient this doee corresponds to 2.9 mg/kg every four hours. The dose administered in the placebdcontrolled clinical trial was 250 mg (2.3 to 5.9 mg/kg depending on body weight) every four hours (see INDICATIONS AND USAGE). Hematologic toxicitiee appear to be related to pretreatment bone marrow reserve and to doee and duration of therapy. Careful monitoring of hematologic indices every two weeks is recommended to detect serious anemia or granulocytope-nia. In patients with hematologic toxicity, reduction in hemoglobin mav occur as early as 2 to 4 weeks, and granulocy-topenia usually occurs after 6 to 8 weeks. Dose Adjustment Significant anemia (hemoglobin of < 7.5 g/dl or reduction of >25% of baseline) and/or significant granulocytopenia (granulocyte count of <750/mms or reduction of >50% from baseline) may require a doee interruption until some evidence of marrow recovery is observed. For less severe anemia or granulocytopenia, a reduction in daily doaa may be adequate. In patients who develop significant anemia, dose modification does not necessarily eliminate the need for transfusion. If marrow recovery occurs following dose modification, gradual increases in dose may be appropriate depending on hematologic indices and patient tolerance. HOW SUPPLIED Retrovir Capsules 100 mg (white, opaque cap and body with a dark blue band) containing 100 mg zidovudine and printed with "Wellcome" and unicorn logo on cap and "Y9C” and "100" on body. Bottles of 100 (NDC 0081-0108-56). Store at 16* to 25*C (59* to 77*F) and protect from light. US. Patent No. 4724232 (Use Patent) Other Pats Pene' Shown in Product Identification Section, page 407 SEPTRA® I.V. INFUSION R [sip 'trait ] (Trimethoprim and Sulfamethoxazole) DESCRIPTION Septra I.V. Infusion (Trimethoprim and Sulfamethoxazole), a sterile solution for intravenous infusion only, isasynthetic antibacterial combination product. Each ml contains 16 mg trimethoprim* and 60 mg sulfamethoxazole compounded with 40% propylene glycol, 10% ethyl alcohol and 0,3% die-thanolamine; 1% benzyl alcohol and 0.1% sodium metabisul-fite added as preservatives, water for injection, and pH adjusted to approximately 10 with sodium hydroxide. Trimethoprim Is 2,4-diammo-M3,4,5-trimethoxybenzyl)-pyrimidine It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the molecular formula C^HihN^Oj, Sulfamethoxazole is NM5-methyl-3-iBOxezoly))euifanila-mide. It is an almost white, odorless, tasteless compound with a molecular weight of253.28 and the molecular formula CjoHjiNAS. CLINICAL PHARMACOLOGY Following a one-hour intravenous infusion of a single doee of 160 mg trimethoprim and 800 mg sulfamethoxazole to 11 patients whose weight ranged from 105 lbs. to 165 lbs. (mean, 143 lbs.), the mean peak plasma concentrations of trimetho-prim andsulfamethoxazoie were 3.4 ± 0.3 pg/ml and 46.3 ± 2.7 pg/ml, respectively. Following repeated intravenous administration of the same doee at eight-hour intervals, the mean plasma concentrations just prior to and immediately after each infusion at steady state were 5.6 ± 0.6 pg/ml ana 6.6 ± 0.9 pg/ml for trimethoprim and 70.6 ± 7.3 pg/ml and 105 6 ± 10.9 pg/ml for sulfamethoxazole. The mean plasma half-life was 21.3 ± 0.7 hours for trimethoprim and 12.8 ± 1.8 hours for sulfamethoxazole All of these 11 patients had normal renal (Unction and their ages ranged from 17 to 78 years (median, 60 years)1. Pharmacokinetic studies in children and adults suggest an age-dependent half-life of trimethoprim as indicated in the following table.2 No. Mean TMP Ag« of Half-life (yrs.) Patients (hours) <1 2 7.67 1-10 9 6.49 10-20 5 8.19 20-63 6 12.82 Patients with severely Impaired renal function exhibit an increase in the half-lives of both components, requiring dosage regimen adjustment (see DOSAGE AND ADMINISTRATION section). Both trimethoprim and sulfamethoxazole exist in the blood as unbound, protein-bound and metabolized forms; sulfa-methoxazole also exists as the conjugated form. The metabolism of sulfamethoxazole occurs predominately by N^acety-lation, although the glucuronide conjugate has been identified. The principal metabolites of trimethoprim are the 1- and 3- oxides and the 3'- and 4'-hydroxy derivatives. The free forms of trimethoprim and sulfamethoxazole are considered to be the therapeutically active forms Approximately 44% of trimethoprim and 70% of sulfamethoxazole are bound to Percentage (%) of Patients with Clinical Events Adverse Event Zidovudine (n»144) Placebo Adverse Event Zidovudine (n=144) Placebo (n=137) BODY AS A WHOLE Asthenia Diaphoresis Headache Malaise GASTROINTESTINAL Anorexia Diarrhea Dyspepsia Nausea Vomiting MUSCULOSKELETAL Myalgia NERVOUS Dizziness Insomnia Somnolence RESPIRATORY Dyspnea SKIN Rash SPECIAL SENSES Taste Perversion piasma proteins. The presence of 10 mg percent sulfa-methofcazole in plasma decreases the protein binding of trimethoprim by an insignificant degree; trimethoprim doee not Influence the protein binding of sulfamethoxazole. Excretion of trimethoprim and sulfamethoxazole is primarily by ths kidneys through both glomerular filtration and tubular aecretion. Urine concentrations of both trimetho-prim andsulfamethoxazoie are considerably higher than are theconcentrationsin the blood. The percent of dote excretad in urine over a 12-hour period following the intravenous administration of the first dose of 240 mg of trimethoprim and 1200 mg of sulfamethoxazole on day 1 ranged from 17% to 42.4% as free trimethoprim; 7% to 12.7% as free sulfa-methoxazole; and 36.7% to 56% os total (freo plus the N«-acetylated metabolite) sulfamethoxazole. When administered together as Septra, neither trimethoprim nor sulfame-thoxazole affects the urinary excretion pattern of the other. Both trimethoprim and sulfamethoxazole distribute to sputum and vaginal fluid; trimethoprim also distributes to bronchial secretions and both pass the placental barrier and are excreted in human milk. Microbiology: Sulfamethoxazole inhibits bacterial synthesis of dihydrofolic acid by competing with para- aminoben-zoic acid (PABA). Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the required enzyme, dihydrofolate reductase. Thus, Septra blocks two consecutive steps in the biosynthesis of nucleic acids and proteins essential to many bacteria. In vitro studies have shown that bacterial resistance develops more slowly with Septra than with trimethoprim or sul-famethoxazole alone. In nitro serial dilution tests have shown that the spectrum of antibacterial activity of Septra includes common bacterial pathogens with the exception of ftiudomona* aeruginosa The following organisms are usually susceptible: Etcktrichia coli, KUbeiella species, Entoroboctor species, Morgantlla mor- ganii, Proteus mirabdts, indole-positive Proteus species, including Prolrui uulgaru, Haemophilut influenzae (including ampiciltin-rcsistant strains), Streptococcus pneumoniae, Shi-gella flexncri and Shigella sonnet. It should be noted, however, that there are little clinical data on the use of Septra I.V. InfUsion in serious systemic infections due to Haemophi-lus influenzae and Streptococcus pneumoniae. [See table on next page]. Susceptibility Testing: The recommended quantitative disc susceptibility method may be used for estimating the susceptibility of bacteria to Septra.9,4 With this procedure, a report from the laboratory of "Susceptible to trimethoprim and sulfamethoxazole” indicates that the infection is likely to respond to therapy with Septra. If the infection is confined to the urine, a report of "Intermediate susceptibility to trimethoprim and sulfamethoxazole" also indicates that the infection is likely to respond. A report of "Resistant to trime-thoprim and sulfamethoxazole" indicates that the infection is unlikely to respond to therapy with Septra. INDICATIONS AND USAGE PNEUMOCYSTIS CAR1N11 PNEUMONIA: Septra I.V. Infusion íb indicated in the treatment ofPneumocyifiscarinii pneumonia in children and adults. SHIGELLOSIS: Septra I.V. Infusion is indicated in the treatment of enteritis caused by susceptible strains of Shi-gella flexnen and Shigella sonnei in children and adults. URINARY TRACT INFECTIONS: Septra I.V. Infusion is indicated in the treatment of severe or complicated urinary tract infections due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella mor-ganii, and Proteus species when ora) administration of Septra is not feasible and when the organism is not susceptible to single agent antibacterials effective in the urinary Although appropriate culture and susceptibility studies should be performed, therapy may be started while awaiting the resulte of these studies. CONTRAINDICATIONS Hypersensitivity to trimethoprim or sulfonamides. Patients with documented megaloblastic anemia due to folate deficiency. Pregnancy at term and during the nursing period, because sulfonamides pass the placenta and are excreted in the milk and may cause kernicterus Infants less than two months of age. WARNINGS FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF 8ULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NE-CROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANU-LOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS. SEPTRA SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF ADVERSE REACTION. Clinical signs, such as rash, sore throat, fever, arthralgia, cough, shortness of breath, pallor, purpura or Continued on next peste

ATTACHMENT D

878 Peachtree Street, N.E. Atlanta, Georgia 30309

June 27, 1989

2342 United States Courthouse

The use of AZT in treating HIV infection is constantly being updated as experience grows. At the recent 5th International Conference on AIDS & HIV Infection, in Montreal, several scientific papers reported that the earlier AZT was started for treatment of HIV patients with T4 cell counts of 200/ml or less, the greater the reduction in mortality, especially in the first two (2) years after treatment was begun. Also, several promising new drugs, close relatives of AZT chemically, are being studied and should be available in six to twelve months.

If I may provide you with any further information, please contact me.

(s) Joseph A. Wilber

Joseph A. Wilber, M.D.

Medical Consultant

Office of Infectious Disease

ATTACHMENT E

10 TREATMENT OF HIV-RELATED IMMUNODEFICIENCY

Many drugs are being investigated for their ability to prevent HIV replication and restore immune function, but many problems must be overcome before effective therapy is achieved. Viral eradication is difficult because HIV genetic material is integrated into the host chromosomal DNA. In addition, HIV infects cells of the central nervous system, providing a reservoir of continued infection if antiviral agents do not cross the blood-brain barrier.

Zidovudine (“AZT,” Retrovir®)

Only one antiviral agent has been clearly shown to improve immune function in AIDS patients. Zidovudine is a competitive inhibitor of reverse transcriptase, the enzyme that copies the viral RNA molecule into DNA. This inhibition prevents viral replication and protects the infected cell. A preliminary study in 1985 showed that the drug may be of benefit: 17 of 25 patients on Zidovudine had increases in the number of T-helper lymphocytes, and six of 16 patients who were anergic at entry developed positive skin tests.46 Subsequent to this, a randomized, placebo-controlled trial of Zidovudine therapy was begun in 280 patients with either a successfully treated episode of P. carinii pneumonia or a history of AIDS-Related Complex.47 The trial began in February, 1986. By September, 1986,19 deaths had occurred in the placebo group and one death in the Zidovudine group. In addition to the difference in mortality rates, patients in the Zidovudine group showed several clinical and immunologic improvements, including a reduction in the number of opportunistic infections. In another clinical trial, Zidovudine treatment was associated with significant neuro-logic improvement in patients with AIDS Dementia Complex or peripheral neuropa-thy.48

Zidovudine causes significant toxicity in some patients. Macrocytic anemia was the most commonly observed toxic effect in the previously mentioned study, necessitating transfusion in 25% of patients. Preliminary data suggest that patients with more advanced cases of AIDS are more likely to experience severe anemia and neutropenia after long-term treatment with Zidovu-dine.49 A newly recognized long-term toxic effect, presented at the Fourth International AIDS Conference at Stockholm, Sweden, in June, 1988, was a syndrome of myalgias associated with an elevation of the CPK.

Whether Zidovudine will be effective for all patients with AIDS is unknown. Burroughs Wellcome and the National Institutes of Health are now conducting studies of Zidovudine in pediatric AIDS patients, adults with Kaposi’s sarcoma, and asymptomatic persons with HIY infection. It is clear that Zidovudine is not a cure for AIDS and may cause serious side effects. Its use should be limited to physicians who routinely treat patients with AIDS.

There is no other effective anti-viral agent available. Several other modalities of treatment are currently under investigation, and many other modalities are being pursued by the “underground.”

It is hoped that clinical research on all agents will be rapid and productive. Some of this research may necessarily come from community research initiatives. These should be carefully developed and conducted.

ATTACHMENT F

July 3, 1989

In response to the question: “Can a patient have symptomatic Human Immunodeficiency Virus (HIV) infection and not have Acquired Immune Deficiency Syndrome (AIDS)?” The answer is yes. AIDS is a carefully defined end stage in the spectrum of disease produced by HIV used mainly for epidemologic and public health purposes. Certain indicator infectious diseases (eg. Pneumocystis Carinii pneumonia, Cryptococcal menigitis, Toxoplasma Gondii encephelitis or certain indicator malignancies (Kaposi’s sarcoma, Primary brain lymphoma) are required to make the diagnosis of AIDS.

Many patients with HIV are symptomatic (i.e. ill) for months or years before the criteria for AIDS are met. Other non-specific symptomatic illnesses occur commonly in patients with HIV infection, (eg. recurrent herpes genitalia, oral candida infections, many different skin disorders, nonspecific fevers, diarrhea and weight loss) but are not diagnostic of AIDS and are also seen in patients without HIV infection.

AIDS Program

ATTACHMENT G

In the United States District Court

for the Northern District of Georgia Atlanta Division

Robert Bruce Hawley, Plaintiff, v. David C. Evans, et al., Defendants.

Civil Action No. 1:88-CV-2185-CAM.

SUPPLEMENT TO CROSS-MOTION FOR SUMMARY JUDGMENT

Comes now before me the undersigned officer duly authorized to administer oaths, L. Newton Turk, M.D., who, after being duly sworn states as follows:

1.

My name is L. Newton Turk, M.D. and I am the Medical Director for the Georgia Department of Corrections. I am over the age of majority and competent to testify in this matter.

2.

Consistent with the Physician's Desk Reference and directives from manufacturer (Burroughs Wellcome), AZT is offered to anyone who is symptomatic HIV infected and whose T-Lymphocytes are 200 or below. This will include the ARC’S or all the AIDS. We would not offer this to everyone whose T-Lymphocytes are below 200 but only to those who have had symptoms and have fallen into the category known as ARC and AIDS.

3.

Those patients who have the HIV virus but have no symptomatic HIV infection will not be offered AZT. For example, if a patient has the HIV virus but shows no signs of illness or shows only minor signs of illness such as night sweats or a body rash, AZT will not be offered to that patient.

4.

This is a general statement concerning the policy of administration of AZT and certain other complicating factors, such as pregnancy or a pre-existing serious disease, may alter the above.

Further, affiant sayeth not. This the 5th Day of July, 1989.

(s) L, Newton Turk M.D,

L. Newton Turk, M.D.

Sworn to and subscribed before me this 5th Day of July, 1989.

(s) [Signature!

Notary Public

1 . In the original complaint, plaintiff Hawley included an equal protection claim against the government. Plaintiffs failed to plead any facts, nor have they cited any law to support such a claim. The cross motions for summary judgment do not address the issue. Therefore this court holds that the equal protection claim has been abandoned. In any event, this court is not aware of any evidence that would support such a claim.

2 . The court does not imply that the defendants might have been negligent. On the contrary, the court finds that the defendants’ actions in this case have been reasonable and acceptable in light of the current state of knowledge as to the proper medication for HIV patients.