Hepatitis C (HCV) is a blood-borne and transmitted disease, caused by a virus that, as its name describes, causes inflammation of the Liver. Although a small percentage of infected individuals may clear the virus by natural immune-response processes, for most the disease is expressed as a slow progression of worsening liver inflammation that will eventually end with cirrhosis, possible liver cancer, and/or death. At the private, for-profit prison facility, owned and operated by the Corrections Corporation of America, located at Florence, Arizona, the program for the treatment of HCV is supervised by Physician Assistant Mike Green. Treatment for the most common genotype (genotype 1) consists of weekly injections of PEG-Intron (Peginterferon alfa-2b) and twice-daily oral doses of Ribasphere (Ripavirin, USP) – usually 600 mg in the morning and 600 mg in the evening. The dosage for PEG-Intron is supposed to be based upon body weight.
Physician Assistant Mike Green has been given complete autonomy to administer the HCV treatment program. In the earliest discussions with this writer, concerning treatment, P.A. Green stated that he didn’t know the exact number of prisoners he had treated, but that it was between 30 and 60 prisoners. Prior to my beginning HCV treatment, the previous physician at this facility, Dr. Barnett, informed me that P.A. Green would determine whether to submit my case for treatment approval and, if approved, would oversee my treatment. The physician presently employed at this facility, Dr. Stapler, when addressing my questions as to appropriate dosages, etc., informed me that she did not know “the provider’s” treatment protocol, nor was she familiar with the drug manufacturer’s dosage recommendations. As will become apparent, the autonomy given P.A. Green is neither granted by his license, nor warranted by his ‘expertise,’ and, the failure of this facility’s physicians to properly oversee P.A. Green’s decisions and actions constitute negligence and the abandonment of their responsibility.
The depth of the problems with the HCV treatment program became apparent when the facility pharmacy ran out of my prescribed PEG-Intron. While a very common occurrence with all other medications, the importance of NEVER depleting HCV treatment medications cannot be overstated. According to the drug manufacturer’s literature, weekly injections of PEG-Intron cannot be skipped and should be injected at the same hour each week. The same applies to the Ribavirin; doses cannot be missed, and the capsules should be taken, with food, during the same hours each day. Akin to chemotherapy, HCV treatment both suppresses and kills the offending virus, and any diminishing of pressure upon the virus provides it an opportunity to mutate and become resistant. This is especially important when treating genotype 1, as there is only a 41% chance of successfully clearing the virus with consistent treatment, anyway. (See Table 2, Schering PEG-Intron Product Information)
Prior to my exile from Alaska, Gastroenteroligist, Dr. Geronimo Sahagun, recommended that I be administered a more effective form of “pegalated” interferon called Pegasys. P.A. Green prescribed PEG-Intron, a cheaper drug with harsher side effects. The form of PEG-Intron I receive comes as a powder, mixed with sterile water at the time of injection. Although packaged in varying strengths, my weekly injections consisted of a 0.4 ml injection prepared from a drug package of 150 mcg/0.5 ml; this actually amounts to a dose of 120 mcg, even though I was originally informed that my weekly dose was to be 126 mcg of PEG-Intron.
Having depleted the packages of 150 mcg/0.5 ml, the nurse appeared with a 120 mcg/ml package. When I asked how she was going to get 126 mcg from a 120 mcg package, she left to “find a calculator to get the proper dose.” When she returned she informed me that P.A. Green had “recalculated” my proper dose to be 96 mcg. I immediately said that the change was inappropriate and asked if that didn’t also mean I had been receiving too much for the previous six weeks. The nurse left to get P.A. Green. When he arrived, calculator in hand, P.A. Green attempted to show me how my proper dosage was supposed to be 96 mcg at a 0.8 injection. I continued to complain that I didn’t think the calculation was right and that 0.8 ml injections could not be obtained from a 0.5 m. drug package. In short order, he became frustrated trying to explain it to me, ordered the nurse to give me a 0.8 ml injection, and departed the room.
The nurse then prepared a 0.8 ml injection using two (2) 120 mcg/0.5 ml drug packages. The dose I received on that day was 192 mcg; well beyond the originally-prescribed 126 mcg, and greater than the drug manufacturer’s recommended maximum dosage for any weight.
What followed was a flurry of telephone calls for research, Request for Medical Care, and a Medical Grievance (See Grievance No. 05-0509). What I discovered was that P.A. Green was not following Schering’s (PEG-Intron’s manufacturer) dosage recommendation. In fact, the standard dose of PEG-Intron for patients undergoing “Combination Therapy” (PEG-Intron and Ribavirin) is 1.5 mcg/kilogram of body weight or, and in my case, 150 mcg per week for any person over 85 kilograms (See Table 5, Schering PEG-Intron Product Information – Recommended PEG-Intron Combination Therapy Dosing). This information was sent by facsimile to the facility Medical Supervisor, Brenda Ortiz.
Two days later, on 8/19/05, I met with Dr. Stapler, who, as I noted above, stated that she did not know the “provider’s protocol” or proper dosage. She did inform me that she would look into the matter and inform me as to my proper dosage. Subsequently, my dosage was corrected to 150 mcg per week – the dose I received on 8/26/05. (See: Sick Call Request, dated 8/23/05).
Subsequent research and discussions with other prisoners undergoing combination therapy of PEG-Intron and Ribavirin has revealed that P.A. Green has, in all likelihood, been calculating PEG-Intron dosages based upon the WRONG DOSING CHART. Rather than utilizing the dosing chart for “Combination Therapy,” he has, apparently, been using the “Monotherapy dosing” chart (See Table 4, Schering PEG-Intron Product Information – Recommended PEG-Intron Monotherapy Dosing).
The failure to maintain medication stocks is a pervasive and systemic problem that has defied correction, even though it is reported to have been the source of fraud in the past. However, there is no telling, at this point, how long the mis-dosing and under-dosing of patients in dosage-critical anti-viral therapy has been going on. What is painfully obvious is that patients involved in the HCV treatment program have failed to be provided with appropriate medical care. Besides being systematically shorted proper medicines, they are denied dietary support for the most efficient uptake of Ribavirin (A high fat meal to be consumed with the medication), appropriate laboratory tests for treatment-caused deviations in the blood and organ functions (blood tests should be conducted at weeks 2, 4, 8, 12, continuing thereafter at 6 week intervals), as well as neuropsychiatric supervision (depression and suicidal/homicidal ideation are common) – save, of course, for P.A. Green’s admonition that if the emotional instability, commonly suffered by HCV treatment patients, results in a “disciplinary action,” that he will not testify in your defense.
A license as a Physician’s Assistant is exactly that: a license to assist a physician. It is not a license to practice medicine independent of actual oversight by a licensed doctor. Where has that oversight been? Where has the Alaska Department of corrections’ Medical Advisory Committee been? Is there financial fraud involved; such as, has the Alaska Department of Corrections been charged for prisoners receiving full dosages, while only under-dosages have been bought and provided to prisoners? Why is a less effective medication being used, rather than that recommended by a specialist who was paid for recommendation?
The bottom line, is that the Department of Corrections has the duty of oversight for the medical care provided (or not) by their contractor, Corrections Corporation of America. Doctors have the duty of oversight for the Physician’s Assistants that work under their authority. Nurses have the duty and responsibility to be familiar with the medications that are prescribed by the appropriate medical authority and administered by themselves. None of the right things have been happening and none of these persons will admit that the wrong things continue to go on unabated. Well, they should all have to pay; with their licenses and their pocketbooks.
By the way, it must be pointed out that, while the proper dosage of PEG-Intron has been clarified and corrected in my case, the same is not true for those of similar body weight and habitus, nor anyone else with whom I have spoken. In other words, the medical staff and supervisors are, apparently, hoping I won’t tell anybody and that no one else will notice...
Anthony L. Brown CCA/FCC 8/29/5Editors Note: This controversy is constant and continuous. CCA's Florence Correctional Center medical staff continue to engage in uncaring and unprofessional, if not incompetent conduct with regard to the HCV Treatment program adminstered to Alaskan prisoners. CCA's Florence Correctional Center Administrative staff continue to stall and prevaricate for their Corporate Masters with no regard for the health of their contractual charges. And Alaska Department of Corrections Officials sweep it all under the rug...
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