At this point you're probably wondering what any of this has to do with animal research?  This is one of those years when the discoveries for which the Nobel Prize was awarded did not depend directly on animal research, but we do not have to look far to see where animal research played its part. Identifying the cause of a disease is just the start, you next have to work out how to prevent or cure it. Where HIV is concerned much has been written about the role of animal research in developing antiviral drugs and vaccines, and rather than going into that now I'll direct you to animalresearch.info which is an excellent introduction to the topic. The role of animal research in the development of HPV vaccines is less well known, so that's what I'd like to discuss here.

Once it had been established that HPV was the cause of most cases of cervical cancer work began on developing vaccines to protect against the virus.  As with any vaccine there was a need to ensure that the vaccine was both safe and capable of stimulation the immune system to protect against the virus, and animal models of HPV infection were sought.  While HPV is specific to humans other papillomaviruses infect species such as cattle, rabbits and dogs, and these provided a good model for the study of papillomavirus vaccines.  Early work on the vaccines proved discouraging. Immunization with whole papillomavirus protected against infection but was simply too dangerous to try in humans since there was a risk that the virus used to immunize could itself cause cancer, it was after all the same virus. This study did however show that a vaccine was possible. The next approach tried was to immunize animals using fragments of virus protein, a common method in vaccine design, but this failed to provide any significant protection (1).  It seemed that the whole virus was required to elicit a strong immune response. The breakthrough came from scientists who were studying the bovine papillomavirus capsid protein L1, a protein that forms the outer shell of the virus.  They found that when the L1 protein was expressed in vitro it could self-assemble to form a virus-like particle (VLP), which when injected into rabbits stimulated the immune system to produce antibodies antibodies that bound strongly to bovine papillomavirus (2).
The discovery that the bovine papillomavirus VLP could stimulate antibody production was good news, but the presence of such antibodies does not necessarily confer protection against the virus, so they next examined if bovine papillomavirus VLPs could protect cattle against bovine papillomavirus, and if VLPs made from the papillomavirus specific to their species could  protect dogs and rabbits against the canine and rabbit papillomavirus's.  The animals were protected, and no adverse effects were noted (1), a success that lead directly to the development of VLP vaccines against HPV.  So far two HPV vaccines have been approved for clinical use, Merck's Gardasil and GlaxoSmithKline's Cervarix, and many states are now considering if they should make immunization against HPV part of their vaccination schedule.  Hopefully, if their price tag does not prove too high, these vaccines will go on to prevent many cervical cancer deaths.

So as usual medical progress is made by scientists working in a variety of disciplines, each playing their part to make breakthroughs possible.

Regards
Paul
1) Schiller J.T. and Lowy D.R. "Papillomavirus-like particles and HPV vaccine development." Seminars in Cancer Biology, Volume 7, pages 373-382 (1996) PubMed: 9284529.
2) Kirnbauer R. et al. "Papillomavirus L1 major capsid protein self-assembles into virus-like particles that are highly immunogenic." Proc Natl Acad Sci U S A., Volume 89(24), pages12180-4 (1992) PubMed: 1334560.

Objective
There is little information about audiologic and vestibular disorders in pediatric patients infected with the Human Immunodeficiency Virus type-1 (HIV-1). The aim of this study was to evaluate audiologic and vestibular disorders in a sample of HIV-1-infected children receiving Highly Active Antiretroviral Therapy.

Methods
Patients underwent pure tone audiometry, speech discrimination testing, auditory brainstem responses, electronystagmography, and rotatory testing. HIV-1 viral load and absolute CD4+ cell counts were registered.

Results
Twenty-three patients were included, aged 4.5 years (median, range 5 months to 16 years). Pure tone audiometry was carried out in 12 children over 4 years of age: 4 (33%) showed hearing loss, 2 were conductive. Auditory brainstem responses were measured in all 23 patients, suggesting conductive hearing loss in 6 and sensorineural hearing loss in 2. Most patients with conductive hearing loss had the antecedent of acute or chronic suppurative otitis media but with dry ears at the time of evaluation (p = 0.003). Abnormal prolongations of interwave intervals in auditory brainstem responses were observed in 3 children (13%, 4 ears), an abnormal morphology in different components of auditory brainstem responses in 4 (17.4%, 7 ears), and abnormal amplitude patterns in 11 patients (48%, 17 ears). Vestibular tests were abnormal in all six patients tested, with asymmetries in caloric and rotatory tests. Although differences were not significant, in general, audiologic abnormalities were more frequent in patients with more prolonged HIV-1 infections, higher viral loads, or lower absolute CD4+ cell counts.

Conclusions
Conductive hearing loss associated with previous otitis media events, abnormalities in auditory brainstem responses suggesting disorders at different levels of the auditory pathways, and unilateral vestibular hyporeflexia were frequent findings in our sample of HIV-1-infected children under Highly Active Antiretroviral Therapy. These findings suggest that HIV-1-infected children should be submitted to audiologic and vestibular evaluation as early as possible in order to reduce their impact on the psychosocial development of these patients.

                                    HIV-AIDS and HAART

                                                Francis W. Wodie

                                                Barry University

                        GMS 731: Epidemiology and Evidence Based Practice

                                             Summer session 2008

                                                Table of Content

Abstract………………………………………………………………………….p 3

Introduction……………………………………………………………………..p 4

Methods………………………………………………………………………….p 4

Discussion………………………………………………………………………..p 6

References…………………………………………………………………….....p 16

Abstract

HIV-AIDS is an epidemic not limited to a specific geographic area, but affecting the entire planet.  AIDS is a disease of the immune system caused by the HIV virus.  It allows the patient to contract opportunistic infections that will ultimately kill him.

It was discovered in the early 1980’s, although it might have been present longer.  The virus is transmitted through exchange of infected blood or bodily fluids. The disease progresses as the immune system gets weaker and weaker.  At present, there is no cure or vaccine.  HAART are the most effective drugs to slow down the disease.  For different reasons, some patients decide to discontinue their treatment.  Discontinuing HAART treatment or non-compliance leads to increased viral loads.  Health department try to promote abstinence, the use of condoms and getting tested, through education and different advertisement campaigns.  Underdeveloped countries like the ones in sub-Saharan Africa are the worst hit, because of a combination of different factors.

                                    HIV-AIDS and HAART                                                       

Introduction

            According to Jeang (2006) HIV-AIDS is now “a pandemic of global proportion”.  Even though most people have a basic understanding of what HIV-AIDS is, in order to better understand that statement, one needs to redefine the Acquired Immune Deficiency Syndrome (AIDS), by describing this disease and explaining its origin.  The explanation for the pandemic part of that statement comes from the etiology of the disease, which is a virus, Human Immunodeficiency Virus (HIV).  The mode of transmission, the infectivity and the severity, but also who is at risk, explain how we ended up where we are now.  Despite efforts from governments and health organization to eradicate the disease, HIV-AIDS is still progressing.  Is it that the response and methods of control of the condition are inappropriate?  How is the disease distributed and how is it perceived worldwide. What is the best option as far as treatment?  Is the disease curable?  What happens when treatment is not followed?  All these questions need to be answered, and the different areas previously mentioned, need to be explored, or re-explored.

Methods

The PICO chosen is:

Patients or population: HIV infected patients receiving highly active antiretroviral therapy (HAART)

Intervention: Stopping the treatment

Comparison/ Gold standard:  Compared to staying on HAART

Outcome of interest: Viral load increases

For the literature review, we started by consulting the Center for Disease Control and Prevention (CDC) web site.  We then performed a search through the Barry University Library.  We went to Medline in PubMed and did a general search on Acquired Immune Deficiency Syndrome (AIDS).  We then performed a search on highly active antiretroviral therapy with the following limits:  the articles had to have been published in the last two years; the articles had to be about humans; the language had to be English; the type of articles selected were clinical trial, meta-analysis, practice guidelines, randomnized controlled trial and review.  After looking at that literature, we narrowed our search to free full articles.

From the literature consulted, we retained the following key clinical evidence/recommendations:

-         “HAART are remarkably effective at suppressing HIV replication” (Purdy, 2008). [evidence level B, retrospective cohort study/ case series]

-         With interruption of HAART, HIV viremia increases and CD4 count drops (Seoane, 2008). [evidence level B, prospective cohort study]

-         Continuous use of HAART associated with cardiovascular problems, but stopping does not decrease risk of having a cardiovascular event (Tebas, 2008). [evidence level A, randomnized controlled trial]

-         No statistical clear association between socioeconomic status and adherence to treatment, but there seems to be a positive trend (Falagas, 2008). [evidence level C, review]

Discussion

AIDS is a disease of the immune system.  People developing the disease have a deficient immune system.  As a result they are unable to fight off otherwise benign infections.  These infections are opportunistic infections, and ultimately lead to the death of the patient.  AIDS was first noticed around 1981 in San Francisco, when many young men developed a form of cancer, Kaposi’s Sarcoma, which previously was only seen in men older than sixty years of age and of Jewish origin (Schneider, 2006).  After investigation, it was noticed that what these patients had in common was their sexual preference (Schneider, 2006).  They were all homosexual males, most engaging in risky sexual behaviors.  A lot of them were also developing pneumonia.  Pretty soon the infection spread to the entire country, and other cases were reported in Europe.  The world had to wait three years before two teams, the Gallo team from the United States, and the Montagnier team from the Pasteur Institute in Paris, France, discovered separately the same virus, responsible for the disease (Jeang, 2006).   After the scientific community realized that the disease was also affecting heterosexual males and females, the virus was named Human Immunodeficiency Virus (HIV).

            It seems that the virus originated in certain populations of chimpanzees in Cameroon and Gabon.  These two countries are both located in West Africa.  In chimpanzees, the virus is called Simian Immunodeficiency Virus (SIV), but the monkeys do not die from it, they are just carriers.  We determined that West African origin from gene sequences and phylogenetic analysis (Cameron, 2006).  The jump of the virus, from chimpanzees to humans and the circumstances of its mutation are still unclear (Cameron, 2006).  Conflicting theories try to explain it, but no consensus has been reached.  However, it seems that this “jump” probably occurred in the 1950’s.  The first two recorded cases of HIV infection are from a man, citizen of the actual Democratic Republic of Congo, who died in 1959, and in 1966 a Norwegian sailor who was said to be well traveled (Schneider, 2006).  This means that AIDS has probably been with us for more than fifty years, but spread recently because of movement of populations and promiscuity in certain societies.

            HIV is a RNA retro virus, of the lentivirus genus (Jeang, 2006).  It is transmitted from human to human, by contact through blood or mucous secretions.  The virus is transmitted essentially from sexual contact between an infected person and a non-infected person.  In the United States, more than half of the infections in males are due to male to male sexual relations (CDC, 2008).  In females, most of the infections are due to hetero sexual relations (CDC, 2008).  Other means of contracting the virus are exchange of contaminated needles among intra-venous drug users (Stevens, 2006).  The last main way of infection, is vertical, with HIV-positive women infecting their babies through vaginal contact during delivery, or by breastfeeding the baby, basically with contaminated milk (Stevens, 2006).  Infections by transfusion of contaminated blood products used to be a big problem in the early 1980’s, but not anymore.  This is due to the fact that all blood products are tested for the presence of HIV.

Transmission categories of adults and adolescents with HIV/AIDS diagnosis during 2006 (CDC, 2008):

Note. Based on data from 33 states with long-term, confidential name-based HIV reporting.

*The most recent year(s) for which these data are available.

By Race/Ethnicity

Although blacks, or African Americans, made up only 13% of the population in the 33 states, they accounted for almost half of the estimated number of HIV/AIDS diagnoses made during 2006.

Race/ethnicity of persons (including children) with
HIV/AIDS diagnosed during 2006

Note. Based on data from 33 states with long-term, confidential name-based HIV reporting.

By Age

In 2006, persons aged 25–34 and persons aged 35–44 accounted for the largest proportions of newly diagnosed HIV/AIDS cases.

Age of persons with HIV/AIDS diagnosed during 2006

            Once the virus gets into the blood, its target is the CD4+ T cells.  CD4+ T cells are important, vital cells of the immune system that multiply after an infection and attack directly the pathogen by binding to its antigen.  They work with macrophages and dendritic cells.  The HIV virus, inserts itself into those CD4+ T cells, transforms its RNA into DNA by reverse transcriptase, and inserts its genome inside its host genetic material.  The virus then multiplies inside the cell, to give millions of new virus that are liberated by lysis, killing at the same time the host cell.  The new viruses, once liberated, move on and infect new CD4+ T cells.  Soon after the infection, a person would show symptoms of mild fever, this is due to the immune system reacting and trying to kill off the virus which at this stage is particularly active.  This is when a person is most likely to infect others.  After this stage, the virus enters a latent period, and the HIV-positive individual is “less” contagious.  That latency period can last for years, even decades, with values ranging from a couple of years to ten or twelve years.  I have to mention here that a subgroup of HIV-positive patient do not seem to develop AIDS, they are called long term nonprogressors.  Another subtype, but this time of the entire population cannot be infected by HIV because they lack receptors on their CD4+ T cells that would otherwise allow the virus to penetrate the cells.  During the latency period the immune system is fighting to contain the virus.  Ultimately, more T-cells are killed than replaced, the immune system fails and the patient progress to AIDS, which the clinical manifestation of HIV.  Once the patient develops AIDS, he is most of the time condemned and has a prognosis of a few months to a couple of years.  The World Health Organization (WHO) has a classification based on the opportunistic diseases that develop as a consequence of the immune system getting weaker and weaker, and also based on the number of CD4+ T cells the patient has.  Stage four is classified as being characteristic of AIDS.  During stage three, according to Dwolatzky (2006), tuberculosis is the “leading clinical manifestation of HIV infection”.  There are 4.4 million new TB cases, with a fourth of them diagnosed in Africa (Dwolatzky, 2006).  Other symptoms of HIV infection are weight loss, diarrhea lasting more than a month, tiredness (Stevens, 2006).  Stage four is characterized by diseases like candidiasis of the esophagus, toxoplasmosis of the brain and Kaposi’s sarcoma.

            Since the beginning of the epidemic health care professionals and health care organizations and governments reacted and started to fight back.  The first step evidently was to investigate in order to learn more about the virus.  Once we were able to identify the virus, researchers moved immediately toward finding a cure, but also a test to detect the virus and a vaccine in order to prevent the disease (Schneider, 2006).  As far as the diagnosis of the disease, an ELISA test followed by a western blot test allows to detect the virus.  The first test rules out infection, while the second one rules in the infection, making this serial test really accurate.  They are also other ways to find the serological status of a patient.  In the 1980s, AZT an antiretroviral was discovered. It helped fight the progression of the virus but did not totally eliminate it.  Another problem is that very fast patients became resistant to AZT, because the virus tends to mutate all the time.  Researchers soon discovered that by combining different drugs, like antiretrovirals and protease inhibitors, one would obtain better results.  This how we got to the highly active antiretroviral therapy (HAART) (Schneider, 2006).  Because of HAART, less and less individuals progress to AIDS and they are able to lead regular lives (Purdy, 2008).  However and because some patients stay for long periods of time on the drugs, they develop metabolic disorders like cardiovascular complications (Tebas, 2008).  In others, especially teenagers that were infected by their mothers and that have been taking the drugs since birth or infancy, the drugs are not effective (Purdy, 2008).  The authors caution that this may be related to them not being compliant with their treatment regimen.  Tebas and al demonstrated that stopping treatment does not reduce cardiovascular events, instead because of increased viremia and inflammatory response, the number of these events increase (Tebas, 2008). One problem with their study is the small sample size that does not necessarily allow them to extend their conclusions to the general population. They defended their study by stating that they were able to measure “direct effects of discontinuation” of HAART (Tebas, 2008).  Others stop treatment for economic reasons.  Seoane et al showed that without HAART, the HIV-RNA increases and the CD4 count decreases.  They state that using certain immunological markers such as CD4+ nadir and LPR is helpful when deciding whether or not to discontinue therapy (Seoane, 2008).  Here again, the problem is the small sample size.  The authors also state that they have no competing interest.  On the front of the vaccine, and because of the high mutation rate of the virus, no functional vaccine has been found, although many are in active trials (Singh, 2006).  Health department also try to educate the public at large and at risk groups in particular.  They try to promote abstinence, and less risky behaviors.  The use of condoms is stressed, also the idea that it is better to be in a monogamous relationship and to get tested (Schneider, 2006).  Because of all these measures, and others, the incidence of HIV infection in the United States has decreased although still around 56,000 individuals get infected every year (CDC, 2008).  The prevalence is rising since like I mentioned earlier, infected people are living longer.  Elsewhere we have not been so successful.

            In other regions of the world, in the developing countries in general and in sub-Saharan Africa in particular, the incidence rates are alarming.  This is due to the fact that health care organizations are having a difficult time educating the populations.  This is due to the fact that often they do not have big enough budgets to create effective campaigns.  Other times governments themselves slow down their actions by not promoting information, and misinforming the public, like in South Africa, where some officials went as far as denying the existence of the HIV virus.  The other major problem is that some cultures promote promiscuity, by encouraging boys and men to have multiple sexual partners, and because of the stigma associated with the disease, only very few people get tested.  As a consequence infected individuals move on and infect more people without even realizing it.  Last, and not least, constant migration of populations due to wars and famines does not allow health care providers to monitor people, educate them to ultimately change their behaviors (Schneider, 2006).

            The AIDS epidemic is so dramatic in the developing countries, because the population is too poor, to get medications once infected.  As a consequence, the disease decimates millions of people, leaving a lot of orphans behind, and crippling those economies even more.  Falagas et al, although they were not able to find statistical clear association between socioeconomic status and adherence to treatment in HIV infected patients, state that a trend might exist here (Falagas, 2008).  This might partially explain what is happening in third world countries, and sometimes even in the United States.

            In conclusion, because it is everywhere, and affects some many people, HIV-AIDS is now a pandemic with no end in sight.  Governments have to understand the need to allocate more resources for the fight against the disease.  In the case of developing countries, the situation is especially alarming, and more needs to be done to stop the epidemic.  The reason is not only compassion, but the problem is global, and has no borders.  If it keeps going, the way it has been going in these countries it will necessarily affect developed, industrialized countries as well, if nothing else with the supply of products these countries bring to the international market.  It is our hope that even though right now it does not look likely, a cure will be found soon, and also a vaccine that will protect unaffected individuals and protect future generations.  Finally, something has to be done to make the drugs, especially HAART, available to those that need them the most.  An international fund, different from what exist right now, to pay for the drugs and give them to underdeveloped countries could be a solution.  Also new regulations, to make them more affordable need to be created.  Government policies need to be created to make sure that the patient once they start treatment stay compliant.  Let us hope that we all realize what needs to be done before it is too late.

References

Cameron, W. (2006). Twenty-five years of AIDS.  Canada’s Leading Medical Journal,

            173, 225-227.

Centers for Disease Control and Prevention. (2008). A glance at the HIV/AIDS epidemic. 

            Retrieved August 14, 2008, from CDC division of HIV/AIDS Prevention Web             site http://www.cdc.gov/hiv/

Dwolatzky, B., & Trengove, E. (2006). Linking the global positioning system (GPS) to a

            personal digital assistant (PDA) to support tuberculosis control in South Africa: a

            pilot study.  International Journal of Health Geographics, 5, 34.

Falagas, M.E. (2008). Socioeconomic status (SES) as a determinant of adherence to                treatment in HIV infected pts: a systematic review of the literature. 

Retrovirology, 5, 13.

Jeang, K-T., & Yedavalli, V. (2006).  Role of RNA helicases in HIV-1 replication. 

            Nucleic Acids Research, 34, 4198-4205.

Purdy, J.B. (2008). Virologic response using directly observed therapy in adolescents    with HIV: an adherence tool.  J Assoc Nurses AIDS Care, 19, 158-165.

Schneider, M. (2006). Introduction to public health (2^nd ed.). Sudbury: Jones and Bartlett.

Seoane, E. (2008). Immunological predictors of CD4+ T cell decline in antiretroviral                 treatment interruptions.  BMC Infect Dis, 8, 20.

Singh, M. (2006).  No vaccine against HIV yet- are we not perfectly equipped?  Virology

            journal, 3, 60.

Stevens, L.M., & Lynn, C. (2006).  HIV infection: the basics.  The Journal of American

            Medical Association, 296. 892.

Tebas, P. (2008). Metabolic and immune activation effects of treatment interruption in   chronic HIV-1 infections: implications for cardiovascular risk.  PLoS ONE, 3,      e2021.

Opportunistic infection is any infection which, under normal circumstances, the body could easily fight off. However, due to the lack of CD4 immune cells, AIDS patients are at very high risk of contracting diseases which they would never contract were it not for the virus destroying their immune system. Some diseases are so common in AIDS patients, and so uncommon in non-AIDS patients, that they are considered to be AIDS-defining diseases. Examples of AIDS-defining diseases include Pneumocystis Pneumonia (a fungal infection of the lungs) and Kaposi’s Sarcoma (once believed to be a rare form of cancer, now believed to be caused by Herpes Virus HHV8); these diseases are normally not seen in patients with a normal immune system. While there is viable treatment for many opportunistic diseases, they must be treated swiftly in an AIDS patient due to the patient’s body being unable to fight infection on its own.

Another important way of measuring HIV is by measuring the viral load. The viral load is the amount of HIV in the body. So while a CD4 count measures the amount of damage HIV has done, a viral load count will measure how much of the virus is actually in the body. In this way, doctors are able to measure whether drugs are working to halt the spread of the virus.

AIDS is a pandemic first identified in 1981 by the Centers for Disease Control (CDC), due to Pneumocystis Pneumonia being identified in five homosexual men in Los Angeles. The disease did not take over worldwide as quickly as it is generally believed, though. AIDS has been identified in tissue samples of patients who died of unknown causes as early as 1959; one postmortem case identified the virus in a tissue sample from a 15-year-old boy who died in St. Louis, Missouri, in 1969, though it is still unknown how the boy may have contracted the virus. Some scientists suggest the virus could have first infected humans sometime during the end of the 19th Century, while other scientists suggest it first infected humans during the early 20th century, between 1915 and 1930. Regardless of whether it started during the late 19th Century or early 20th Century, it took many decades for it to even become prevalent enough to be noticed. Since the virus is slow to overtake its host, the window for inadvertent infection of others is years, rather than days or weeks as with most viruses.

It is unclear exactly how the virus started, but it seems clear that it crossed species from primates (which can carry a disease known as the Simian Immunodeficiency Virus) into humans, likely when humans came into contact with the bodily fluids of monkeys, possibly during consumption, hunting or butchering the animals (monkey meat is a delicacy in some areas of the world, and is regularly eaten in some areas of Africa). The virus spread due to a number of factors, including vaccines given with unclean needles in developing countries. While AIDS is now generally viewed as a disease of gay men and intravenous drug users, the truth is far more chilling, since the virus is not contained only within a particular population. Many women and children are infected with the virus, and in some areas of the world, particularly Africa where infected patients do not have access to proper health care, the number of deaths has become catastrophic.

At this time, there is no cure for HIV, or for AIDS, nor is there a vaccine to prevent transmission. However, scientists have designed a number of drugs inhibit the virus’s replication. To understand how these drugs work, a short primer on the virus is necessary.

HIV takes over CD4 cells, changing their molecular structure by inserting its own ribonucleic acid (RNA). The virus itself, which is too small to be seen except with an electron microscope, consists of an outer envelope containing the virus and the proteins and enzymes necessary for replication; the envelope has about 72 spikes on its surface. When the virus bumps into a cell coated by the CD4 protein, the spikes stick into the cell and fuse, at which time the inner contents of the HIV envelope is released into the CD4 cell.

Once inside the cell, the HIV enzyme called reverse transciptase converts the viral RNA into DNA, which is compatible with human genetic material. This DNA is transported to the cell’s nucleus, where it is spliced into the human DNA by the HIV enzyme called integrase. Once it is spliced into the human DNA, the HIV DNA is known as provirus. The provirus may lie dormant within a cell for quite some time. However, when the cell becomes activated, it treats HIV genes in almost the same way as human genes. First it uses human enzymes to convert HIV genes into messenger RNA. The messenger RNA is transported outside the cell nucleus, and is used as a blueprint for producing new HIV proteins and enzymes, much in the same way as the human body normally produce replacement cells.

Complete copies of HIV genetic material is contained among the strands of messenger RNA produced by the cell. These copies combine with newly made HIV proteins and enzymes to form new viral particles, which are then released from the cell. The enzyme protease plays a vital role of the HIV life cycle, as it chops up long strands of protein into smaller pieces, which are then used to construct mature viral cores. At that point the newly matured HIV particles are ready to infect another cell, and begin the replication process all over again. In this way the virus quickly spreads through the human body, and causes its host to become infectious. HIV is passed to others through bodily fluids; some fluids contain more of the virus than others.

Contrary to popular belief, people do not die of HIV, or of AIDS. They die of the opportunistic infections which accompany the complete loss of their immune system. Patients therefore must take a strong cocktail of medications to stop the virus from replicating and destroying their immune system. Some common drugs prescribed for AIDS patients, to stop the virus from replicating, include reverse transcriptase inhibitors, which prevent the viral RNA from being converted into human DNA; protease inhibitors, which prevent the virus from creating new mature viral cores; and integrase inhibitors, which prevent the viral DNA from being spliced into the human DNA within the cells.

Unfortunately, with those life-saving treatments for the virus come life-threatening side effects, from lethal liver damage to an overwhelming nausea which results in starvation and dehydration; when this occurs, it only worsens those same symptoms which can be caused by the virus itself. Over the years many drugs have been discovered to combat the side effects (those same side effects are found in many other medical conditions as well), and to increase the quality of life for those who are infected with the virus; some of those drugs and treatments are pharmaceutical in nature, and some are natural.

One of the non-pharmaceutical drugs, which has proven very helpful in battling the anxiety, overwhelming nausea and physical wasting which comes with the virus and its treatment, is marijuana. So effective is marijuana that scientists have even made a pharmaceutical version of the drug, used in chemotherapy patients as well as AIDS patients, which contains synthetic THC (the active ingredient in marijuana). However, many patients believe that the natural THC in marijuana works better than the synthetic version in Marinol, and science supports this belief. In studies of marijuana usage for medicinal usage, it was found that other chemicals found in marijuana have additional medicinal effects which complement the effects of THC. Furthermore Marinol is extremely expensive (Tom’s Marinol costs about $2200 per month, so severe is his nausea and gastrointestinal symptoms), and thus the drug is far beyond the financial reach of most patients; and for that reason they cultivate and smoke marijuana for medicinal purposes. While the black market cost of marijuana can be high, the plant can be cultivated at home from seeds, at very little cost to the patient.

In some states, it is legal for patients with a valid medical prescription to possess certain amounts of dried and cultivated marijuana for personal medicinal use. However, even in those states, the US Government - which has declared that marijuana is an illicit and therefore illegal drug - refuses to permit patients to use the cultivated form of THC. Patients are regularly arrested for merely possessing the substance which allows them to live a more normal life, and which in cases of extreme wasting seen in AIDS, is actually life-saving. This occurs nationwide, including in the states where marijuana is legal for medicinal use.

I do not advocate the casual use of marijuana (or any other drug, prescription or otherwise) to get “high”. I do strongly advocate the right of physicians and patients to determine the best course of treatment, and I believe the government has no right to interfere in the doctor/patient relationship when the patient is not being placed in untoward danger.

Enter Tom Faltynowicz. When Tom was diagnosed with AIDS in 1990, he was given “maybe a few years” to live. Eighteen years later, he is in a fight for his life, but it’s a fight of a very different kind.

In September 2007, law enforcement officials in his native Meade County received an anonymous call, stating that Tom had between 75 and 100 marijuana plants growing behind a metal building on his property. It is believed that the anonymous call came from Tom’s daughter, who was angry with him because he had recently stated his disapproval of her relationship with a particular man.

When Meade County Investigator Michael Walker and South Dakota Division of Criminal Investigation Agent John Griswold arrived at Tom’s home the next day, there were not 75 to 100 plants on the property, or even anywhere near that many; in fact, there were no plants out in the open at all. However, when asked by those officers about the accusation, Tom immediately admitted to growing marijuana to treat his medical condition. He even invited the officers into his home, so they can see where he was growing it, and he was completely cooperative at all times, even according to the police report regarding the incident. All told, the officers found five plants, and about four ounces of dried marijuana. There was never an allegation that the marijuana was being used for anything but his medical condition, and never an allegation that he was selling the marijuana. It remains undisputed that Tom was using the marijuana to treat AIDS, and the side effects of the many potent medications he takes to fight the virus.

Tom takes a total of four antiretroviral drugs to combat the HIV infection: Combivir (a combination of Retrovir and Epivir), Sustiva, and Viread. Each of these drugs, by themselves, come with potentially fatal side effects. All of these drugs can cause severe nausea, and can result in extreme anxiety as an additional side effect. In addition, Tom has been prescribed Marinol, the synthetic THC drug to combat nausea and vomiting, so there is no question that he suffers the side effects which are treated by marijuana, and there is no question that his side effects are severe based upon his dosage. However, Tom says that the marijuana is far more effective than the Marinol, since Marinol makes him so tired that he cannot function; and his physician is aware of and supports his use of marijuana to treat his symptoms.

Tom, though he has no prior criminal record with the exception of two prior misdemeanor convictions for possession of small amounts of marijuana - both of which occurred after he was diagnosed with AIDS - pled guilty to felony possession of marijuana. He faces a maximum of two years in prison, and a maximum fine of $4000; he could also be given probation. His sentencing date has been set for April 21st, before the Honorable Jerome Eckrich, Circuit Judge. Tom’s Infectious Disease Specialist, Dr. Traub, will speak at the sentencing hearing. The State Attorney has already said that he will not object to anything Dr. Traub might say. It appears that no one is interested in punishing Tom Faltynowicz; at the same time, under the law, his possession of marijuana - regardless of the reason why he possessed it - is a felony in the state of South Dakota.

Tom, however, is an exception to the reason that law was written. It was written to stop people from abusing the drug to get high, and to stop them from selling or otherwise providing it to others for the same illicit purpose. It is extremely doubtful the legislature was aware of the medicinal effects of marijuana when that law was passed, and it’s extremely doubtful the legislature ever intended to punish patients with a deadly disease. It’s even possible that the medicinal effects of marijuana were unknown to them when that law was passed, since it is hardly a new law. Nevertheless, since the law exists, it will be enforced, even against people like Tom who are using marijuana strictly for medicinal purposes.

This raises a number of questions. Even if Tom is merely placed on probation, and even if he stopped smoking marijuana altogether, using Marinol to control his symptoms would result in violation of probation, since he would test positive for THC during required drug tests. If he fails a drug test while on probation, he will be incarcerated.

If he is incarcerated, he will not only not have access to the drug which he needs to survive without excessive suffering due to overwhelming nausea, vomiting, physical wasting, and extreme fatigue; but the South Dakota Department of Corrections will be forced to pay for the extremely expensive antiretroviral drugs which fight the virus as well as the Marinol, at a cost of thousands of dollars per month to the taxpayers, in addition to the increased cost of incarceration for a man with an infectious deadly disease. As you should understand after my explanation of how those drugs work, and how the virus works, missing even one dose of his antiretroviral drugs could be catastrophic for his health, since it would allow the virus to replicate until the drug was again built up to a therapeutic dosage. Yet in a prison environment there is no guarantee that he will receive his life-sustaining medications at all, much less receive them on the schedule those drugs demand.

Tom has said that he will not stop using marijuana, because it allows him to live a relatively normal life. Without it, his body is wracked with pain, nausea, and vomiting; he is unable to eat or drink, and thus his body becomes even more weakened, even more unable to fight the virus, and even more prone to the many opportunistic illnesses, any one of which could easily end his life. This is especially true if he is confined in a jail or prison facility, given that there are large numbers of inmates living in close approximation.

To incarcerate Tom Faltynowicz would therefore place his life at severe risk, and as such would clearly constitute cruel and unusual punishment, as prohibited by the Eighth Amendment of the US Constitution. Furthermore, it would serve no purpose to incarcerate him, since his crime is merely possession of a drug which allows him to live with his disease and to continue take the cruel medications which literally keep him alive. He poses no threat to anyone and he is not selling or otherwise distributing the marijuana, nor has it even been suggested that he is selling or distributing the marijuana. Rehabilitation is also not a valid cause for his incarceration, since he merely uses the drug for medicinal purposes, and thus he is not in need of rehabilitation.

Society would not be served by incarcerating Tom Faltynowicz. The interests of justice would not be served by incarcerating Tom Faltynowicz.

As such, justice demands that the court show mercy by giving Tom Faltynowicz a suspended sentence, no probation, and whatever fine the court sees fit, as long as it is within Tom’s ability to pay said fine.

For those of you unaware of the specifics of that disease, a patient infected with the Human Immunodeficiency Virus (HIV) may or may not develop AIDS. Once infected with HIV, the disease damages the CD4 cells (T-Cells), and in fact uses those cells to replicate within the body; CD4 cells can be replaced through normal process in the early stages of the disease, but eventually the counts start to fall as the cells are overcome by the virus. A CD4 count between 700 and 1000 is considered normal in a non-HIV infected person; while a CD4 count of about 500 is considered normal when the virus is present. A CD4 count below 200 is indicative of AIDS, since it is at that point that the body loses its ability to fight off opportunistic infection.

Opportunistic infection is any infection which, under normal circumstances, the body could easily fight off. However, due to the lack of CD4 immune cells, AIDS patients are at very high risk of contracting diseases which they would never contract were it not for the virus destroying their immune system. Some diseases are so common in AIDS patients, and so uncommon in non-AIDS patients, that they are considered to be AIDS-defining diseases. Examples of AIDS-defining diseases include Pneumocystis Pneumonia (a fungal infection of the lungs) and Kaposi’s Sarcoma (once believed to be a rare form of cancer, now believed to be caused by Herpes Virus HHV8); these diseases are normally not seen in patients with a normal immune system. While there is viable treatment for many opportunistic diseases, they must be treated swiftly in an AIDS patient due to the patient’s body being unable to fight infection on its own.

Another important way of measuring HIV is by measuring the viral load. The viral load is the amount of HIV in the body. So while a CD4 count measures the amount of damage HIV has done, a viral load count will measure how much of the virus is actually in the body. In this way, doctors are able to measure whether drugs are working to halt the spread of the virus.

AIDS is a pandemic first identified in 1981 by the Centers for Disease Control (CDC), due to Pneumocystis Pneumonia being identified in five homosexual men in Los Angeles. The disease did not take over worldwide as quickly as it is generally believed, though. AIDS has been identified in tissue samples of patients who died of unknown causes as early as 1959; one postmortem case identified the virus in a tissue sample from a 15-year-old boy who died in St. Louis, Missouri, in 1969, though it is still unknown how the boy may have contracted the virus. Some scientists suggest the virus could have first infected humans sometime during the end of the 19th Century, while other scientists suggest it first infected humans during the early 20th century, between 1915 and 1930. Regardless of whether it started during the late 19th Century or early 20th Century, it took many decades for it to even become prevalent enough to be noticed. Since the virus is slow to overtake its host, the window for inadvertent infection of others is years, rather than days or weeks as with most viruses.

It is unclear exactly how the virus started, but it seems clear that it crossed species from primates (which can carry a disease known as the Simian Immunodeficiency Virus) into humans, likely when humans came into contact with the bodily fluids of monkeys, possibly during consumption, hunting or butchering the animals (monkey meat is a delicacy in some areas of the world, and is regularly eaten in some areas of Africa). The virus spread due to a number of factors, including vaccines given with unclean needles in developing countries. While AIDS is now generally viewed as a disease of gay men and intravenous drug users, the truth is far more chilling, since the virus is not contained only within a particular population. Many women and children are infected with the virus, and in some areas of the world, particularly Africa where infected patients do not have access to proper health care, the number of deaths has become catastrophic.

At this time, there is no cure for HIV, or for AIDS, nor is there a vaccine to prevent transmission. However, scientists have designed a number of drugs inhibit the virus’s replication. To understand how these drugs work, a short primer on the virus is necessary.

HIV takes over CD4 cells, changing their molecular structure by inserting its own ribonucleic acid (RNA). The virus itself, which is too small to be seen except with an electron microscope, consists of an outer envelope containing the virus and the proteins and enzymes necessary for replication; the envelope has about 72 spikes on its surface. When the virus bumps into a cell coated by the CD4 protein, the spikes stick into the cell and fuse, at which time the inner contents of the HIV envelope is released into the CD4 cell.

Once inside the cell, the HIV enzyme called reverse transciptase converts the viral RNA into DNA, which is compatible with human genetic material. This DNA is transported to the cell’s nucleus, where it is spliced into the human DNA by the HIV enzyme called integrase. Once it is spliced into the human DNA, the HIV DNA is known as provirus. The provirus may lie dormant within a cell for quite some time. However, when the cell becomes activated, it treats HIV genes in almost the same way as human genes. First it uses human enzymes to convert HIV genes into messenger RNA. The messenger RNA is transported outside the cell nucleus, and is used as a blueprint for producing new HIV proteins and enzymes, much in the same way as the human body normally produce replacement cells.

Complete copies of HIV genetic material is contained among the strands of messenger RNA produced by the cell. These copies combine with newly made HIV proteins and enzymes to form new viral particles, which are then released from the cell. The enzyme protease plays a vital role of the HIV life cycle, as it chops up long strands of protein into smaller pieces, which are then used to construct mature viral cores. At that point the newly matured HIV particles are ready to infect another cell, and begin the replication process all over again. In this way the virus quickly spreads through the human body, and causes its host to become infectious. HIV is passed to others through bodily fluids; some fluids contain more of the virus than others.

Contrary to popular belief, people do not die of HIV, or of AIDS. They die of the opportunistic infections which accompany the complete loss of their immune system. Patients therefore must take a strong cocktail of medications to stop the virus from replicating and destroying their immune system. Some common drugs prescribed for AIDS patients, to stop the virus from replicating, include reverse transcriptase inhibitors, which prevent the viral RNA from being converted into human DNA; protease inhibitors, which prevent the virus from creating new mature viral cores; and integrase inhibitors, which prevent the viral DNA from being spliced into the human DNA within the cells.

Unfortunately, with those life-saving treatments for the virus come life-threatening side effects, from lethal liver damage to an overwhelming nausea which results in starvation and dehydration; when this occurs, it only worsens those same symptoms which can be caused by the virus itself. Over the years many drugs have been discovered to combat the side effects (those same side effects are found in many other medical conditions as well), and to increase the quality of life for those who are infected with the virus; some of those drugs and treatments are pharmaceutical in nature, and some are natural.

One of the non-pharmaceutical drugs, which has proven very helpful in battling the anxiety, overwhelming nausea and physical wasting which comes with the virus and its treatment, is marijuana. So effective is marijuana that scientists have even made a pharmaceutical version of the drug, used in chemotherapy patients as well as AIDS patients, which contains synthetic THC (the active ingredient in marijuana). However, many patients believe that the natural THC in marijuana works better than the synthetic version in Marinol, and science supports this belief. In studies of marijuana usage for medicinal usage, it was found that other chemicals found in marijuana have additional medicinal effects which complement the effects of THC. Furthermore Marinol is extremely expensive (Tom’s Marinol costs about $2200 per month, so severe is his nausea and gastrointestinal symptoms), and thus the drug is far beyond the financial reach of most patients; and for that reason they cultivate and smoke marijuana for medicinal purposes. While the black market cost of marijuana can be high, the plant can be cultivated at home from seeds, at very little cost to the patient.

In some states, it is legal for patients with a valid medical prescription to possess certain amounts of dried and cultivated marijuana for personal medicinal use. However, even in those states, the US Government - which has declared that marijuana is an illicit and therefore illegal drug - refuses to permit patients to use the cultivated form of THC. Patients are regularly arrested for merely possessing the substance which allows them to live a more normal life, and which in cases of extreme wasting seen in AIDS, is actually life-saving. This occurs nationwide, including in the states where marijuana is legal for medicinal use.

I do not advocate the casual use of marijuana (or any other drug, prescription or otherwise) to get “high”. I do strongly advocate the right of physicians and patients to determine the best course of treatment, and I believe the government has no right to interfere in the doctor/patient relationship when the patient is not being placed in untoward danger.

Enter Tom Faltynowicz. When Tom was diagnosed with AIDS in 1990, he was given “maybe a few years” to live. Eighteen years later, he is in a fight for his life, but it’s a fight of a very different kind.

In September 2007, law enforcement officials in his native Meade County received an anonymous call, stating that Tom had between 75 and 100 marijuana plants growing behind a metal building on his property. It is believed that the anonymous call came from Tom’s daughter, who was angry with him because he had recently stated his disapproval of her relationship with a particular man.

When Meade County Investigator Michael Walker and South Dakota Division of Criminal Investigation Agent John Griswold arrived at Tom’s home the next day, there were not 75 to 100 plants on the property, or even anywhere near that many; in fact, there were no plants out in the open at all. However, when asked by those officers about the accusation, Tom immediately admitted to growing marijuana to treat his medical condition. He even invited the officers into his home, so they can see where he was growing it, and he was completely cooperative at all times, even according to the police report regarding the incident. All told, the officers found five plants, and about four ounces of dried marijuana. There was never an allegation that the marijuana was being used for anything but his medical condition, and never an allegation that he was selling the marijuana. It remains undisputed that Tom was using the marijuana to treat AIDS, and the side effects of the many potent medications he takes to fight the virus.

Tom takes a total of four antiretroviral drugs to combat the HIV infection: Combivir (a combination of Retrovir and Epivir), Sustiva, and Viread. Each of these drugs, by themselves, come with potentially fatal side effects. All of these drugs can cause severe nausea, and can result in extreme anxiety as an additional side effect. In addition, Tom has been prescribed Marinol, the synthetic THC drug to combat nausea and vomiting, so there is no question that he suffers the side effects which are treated by marijuana, and there is no question that his side effects are severe based upon his dosage. However, Tom says that the marijuana is far more effective than the Marinol, since Marinol makes him so tired that he cannot function; and his physician is aware of and supports his use of marijuana to treat his symptoms.

Tom, though he has no prior criminal record with the exception of two prior misdemeanor convictions for possession of small amounts of marijuana - both of which occurred after he was diagnosed with AIDS - pled guilty to felony possession of marijuana. He faces a maximum of two years in prison, and a maximum fine of $4000; he could also be given probation. His sentencing date has been set for April 21st, before the Honorable Jerome Eckrich, Circuit Judge. Tom’s Infectious Disease Specialist, Dr. Traub, will speak at the sentencing hearing. The State Attorney has already said that he will not object to anything Dr. Traub might say. It appears that no one is interested in punishing Tom Faltynowicz; at the same time, under the law, his possession of marijuana - regardless of the reason why he possessed it - is a felony in the state of South Dakota.

Tom, however, is an exception to the reason that law was written. It was written to stop people from abusing the drug to get high, and to stop them from selling or otherwise providing it to others for the same illicit purpose. It is extremely doubtful the legislature was aware of the medicinal effects of marijuana when that law was passed, and it’s extremely doubtful the legislature ever intended to punish patients with a deadly disease. It’s even possible that the medicinal effects of marijuana were unknown to them when that law was passed, since it is hardly a new law. Nevertheless, since the law exists, it will be enforced, even against people like Tom who are using marijuana strictly for medicinal purposes.

This raises a number of questions. Even if Tom is merely placed on probation, and even if he stopped smoking marijuana altogether, using Marinol to control his symptoms would result in violation of probation, since he would test positive for THC during required drug tests. If he fails a drug test while on probation, he will be incarcerated.

If he is incarcerated, he will not only not have access to the drug which he needs to survive without excessive suffering due to overwhelming nausea, vomiting, physical wasting, and extreme fatigue; but the South Dakota Department of Corrections will be forced to pay for the extremely expensive antiretroviral drugs which fight the virus as well as the Marinol, at a cost of thousands of dollars per month to the taxpayers, in addition to the increased cost of incarceration for a man with an infectious deadly disease. As you should understand after my explanation of how those drugs work, and how the virus works, missing even one dose of his antiretroviral drugs could be catastrophic for his health, since it would allow the virus to replicate until the drug was again built up to a therapeutic dosage. Yet in a prison environment there is no guarantee that he will receive his life-sustaining medications at all, much less receive them on the schedule those drugs demand.

Tom has said that he will not stop using marijuana, because it allows him to live a relatively normal life. Without it, his body is wracked with pain, nausea, and vomiting; he is unable to eat or drink, and thus his body becomes even more weakened, even more unable to fight the virus, and even more prone to the many opportunistic illnesses, any one of which could easily end his life. This is especially true if he is confined in a jail or prison facility, given that there are large numbers of inmates living in close approximation.

To incarcerate Tom Faltynowicz would therefore place his life at severe risk, and as such would clearly constitute cruel and unusual punishment, as prohibited by the Eighth Amendment of the US Constitution. Furthermore, it would serve no purpose to incarcerate him, since his crime is merely possession of a drug which allows him to live with his disease and to continue take the cruel medications which literally keep him alive. He poses no threat to anyone and he is not selling or otherwise distributing the marijuana, nor has it even been suggested that he is selling or distributing the marijuana. Rehabilitation is also not a valid cause for his incarceration, since he merely uses the drug for medicinal purposes, and thus he is not in need of rehabilitation.

Society would not be served by incarcerating Tom Faltynowicz. The interests of justice would not be served by incarcerating Tom Faltynowicz.

As such, justice demands that the court show mercy by giving Tom Faltynowicz a suspended sentence, no probation, and whatever fine the court sees fit, as long as it is within Tom’s ability to pay said fine.

For those of you unaware of the specifics of that disease, a patient infected with the Human Immunodeficiency Virus (HIV) may or may not develop AIDS. Once infected with HIV, the disease damages the CD4 cells (T-Cells), and in fact uses those cells to replicate within the body; CD4 cells can be replaced through normal process in the early stages of the disease, but eventually the counts start to fall as the cells are overcome by the virus. A CD4 count between 700 and 1000 is considered normal in a non-HIV infected person; while a CD4 count of about 500 is considered normal when the virus is present. A CD4 count below 200 is indicative of AIDS, since it is at that point that the body loses its ability to fight off opportunistic infection.

Opportunistic infection is any infection which, under normal circumstances, the body could easily fight off. However, due to the lack of CD4 immune cells, AIDS patients are at very high risk of contracting diseases which they would never contract were it not for the virus destroying their immune system. Some diseases are so common in AIDS patients, and so uncommon in non-AIDS patients, that they are considered to be AIDS-defining diseases. Examples of AIDS-defining diseases include Pneumocystis Pneumonia (a fungal infection of the lungs) and Kaposi's Sarcoma (once believed to be a rare form of cancer, now believed to be caused by Herpes Virus HHV8); these diseases are normally not seen in patients with a normal immune system. While there is viable treatment for many opportunistic diseases, they must be treated swiftly in an AIDS patient due to the patient's body being unable to fight infection on its own.

Another important way of measuring HIV is by measuring the viral load. The viral load is the amount of HIV in the body. So while a CD4 count measures the amount of damage HIV has done, a viral load count will measure how much of the virus is actually in the body. In this way, doctors are able to measure whether drugs are working to halt the spread of the virus.

AIDS is a pandemic first identified in 1981 by the Centers for Disease Control (CDC), due to Pneumocystis Pneumonia being identified in five homosexual men in Los Angeles. The disease did not take over worldwide as quickly as it is generally believed, though. AIDS has been identified in tissue samples of patients who died of unknown causes as early as 1959; one postmortem case identified the virus in a tissue sample from a 15-year-old boy who died in St. Louis, Missouri, in 1969, though it is still unknown how the boy may have contracted the virus. Some scientists suggest the virus could have first infected humans sometime during the end of the 19th Century, while other scientists suggest it first infected humans during the early 20th century, between 1915 and 1930. Regardless of whether it started during the late 19th Century or early 20th Century, it took many decades for it to even become prevalent enough to be noticed. Since the virus is slow to overtake its host, the window for inadvertent infection of others is years, rather than days or weeks as with most viruses.

It is unclear exactly how the virus started, but it seems clear that it crossed species from primates (which can carry a disease known as the Simian Immunodeficiency Virus) into humans, likely when humans came into contact with the bodily fluids of monkeys, possibly during consumption, hunting or butchering the animals (monkey meat is a delicacy in some areas of the world, and is regularly eaten in some areas of Africa). The virus spread due to a number of factors, including vaccines given with unclean needles in developing countries. While AIDS is now generally viewed as a disease of gay men and intravenous drug users, the truth is far more chilling, since the virus is not contained only within a particular population. Many women and children are infected with the virus, and in some areas of the world, particularly Africa where infected patients do not have access to proper health care, the number of deaths has become catastrophic.

At this time, there is no cure for HIV, or for AIDS, nor is there a vaccine to prevent transmission. However, scientists have designed a number of drugs inhibit the virus's replication. To understand how these drugs work, a short primer on the virus is necessary.

HIV takes over CD4 cells, changing their molecular structure by inserting its own ribonucleic acid (RNA). The virus itself, which is too small to be seen except with an electron microscope, consists of an outer envelope containing the virus and the proteins and enzymes necessary for replication; the envelope has about 72 spikes on its surface. When the virus bumps into a cell coated by the CD4 protein, the spikes stick into the cell and fuse, at which time the inner contents of the HIV envelope is released into the CD4 cell.

Once inside the cell, the HIV enzyme called reverse transciptase converts the viral RNA into DNA, which is compatible with human genetic material. This DNA is transported to the cell's nucleus, where it is spliced into the human DNA by the HIV enzyme called integrase. Once it is spliced into the human DNA, the HIV DNA is known as provirus. The provirus may lie dormant within a cell for quite some time. However, when the cell becomes activated, it treats HIV genes in almost the same way as human genes. First it uses human enzymes to convert HIV genes into messenger RNA. The messenger RNA is transported outside the cell nucleus, and is used as a blueprint for producing new HIV proteins and enzymes, much in the same way as the human body normally produce replacement cells.

Complete copies of HIV genetic material is contained among the strands of messenger RNA produced by the cell. These copies combine with newly made HIV proteins and enzymes to form new viral particles, which are then released from the cell. The enzyme protease plays a vital role of the HIV life cycle, as it chops up long strands of protein into smaller pieces, which are then used to construct mature viral cores. At that point the newly matured HIV particles are ready to infect another cell, and begin the replication process all over again. In this way the virus quickly spreads through the human body, and causes its host to become infectious. HIV is passed to others through bodily fluids; some fluids contain more of the virus than others.

Contrary to popular belief, people do not die of HIV, or of AIDS. They die of the opportunistic infections which accompany the complete loss of their immune system. Patients therefore must take a strong cocktail of medications to stop the virus from replicating and destroying their immune system. Some common drugs prescribed for AIDS patients, to stop the virus from replicating, include reverse transcriptase inhibitors, which prevent the viral RNA from being converted into human DNA; protease inhibitors, which prevent the virus from creating new mature viral cores; and integrase inhibitors, which prevent the viral DNA from being spliced into the human DNA within the cells.

Unfortunately, with those life-saving treatments for the virus come life-threatening side effects, from lethal liver damage to an overwhelming nausea which results in starvation and dehydration; when this occurs, it only worsens those same symptoms which can be caused by the virus itself. Over the years many drugs have been discovered to combat the side effects (those same side effects are found in many other medical conditions as well), and to increase the quality of life for those who are infected with the virus; some of those drugs and treatments are pharmaceutical in nature, and some are natural.

One of the non-pharmaceutical drugs, which has proven very helpful in battling the anxiety, overwhelming nausea and physical wasting which comes with the virus and its treatment, is marijuana. So effective is marijuana that scientists have even made a pharmaceutical version of the drug, used in chemotherapy patients as well as AIDS patients, which contains synthetic THC (the active ingredient in marijuana). However, many patients believe that the natural THC in marijuana works better than the synthetic version in Marinol, and science supports this belief. In studies of marijuana usage for medicinal usage, it was found that other chemicals found in marijuana have additional medicinal effects which complement the effects of THC. Furthermore Marinol is extremely expensive (Tom's Marinol costs about $2200 per month, so severe is his nausea and gastrointestinal symptoms), and thus the drug is far beyond the financial reach of most patients; and for that reason they cultivate and smoke marijuana for medicinal purposes. While the black market cost of marijuana can be high, the plant can be cultivated at home from seeds, at very little cost to the patient.

In some states, it is legal for patients with a valid medical prescription to possess certain amounts of dried and cultivated marijuana for personal medicinal use. However, even in those states, the US Government - which has declared that marijuana is an illicit and therefore illegal drug - refuses to permit patients to use the cultivated form of THC. Patients are regularly arrested for merely possessing the substance which allows them to live a more normal life, and which in cases of extreme wasting seen in AIDS, is actually life-saving. This occurs nationwide, including in the states where marijuana is legal for medicinal use.

I do not advocate the casual use of marijuana (or any other drug, prescription or otherwise) to get "high". I do strongly advocate the right of physicians and patients to determine the best course of treatment, and I believe the government has no right to interfere in the doctor/patient relationship when the patient is not being placed in untoward danger.

Enter Tom Faltynowicz. When Tom was diagnosed with AIDS in 1990, he was given "maybe a few years" to live. Eighteen years later, he is in a fight for his life, but it's a fight of a very different kind.

In September 2007, law enforcement officials in his native Meade County received an anonymous call, stating that Tom had between 75 and 100 marijuana plants growing behind a metal building on his property. It is believed that the anonymous call came from Tom's daughter, who was angry with him because he had recently stated his disapproval of her relationship with a particular man.

When Meade County Investigator Michael Walker and South Dakota Division of Criminal Investigation Agent John Griswold arrived at Tom's home the next day, there were not 75 to 100 plants on the property, or even anywhere near that many; in fact, there were no plants out in the open at all. However, when asked by those officers about the accusation, Tom immediately admitted to growing marijuana to treat his medical condition. He even invited the officers into his home, so they can see where he was growing it, and he was completely cooperative at all times, even according to the police report regarding the incident. All told, the officers found five plants, and about four ounces of dried marijuana. There was never an allegation that the marijuana was being used for anything but his medical condition, and never an allegation that he was selling the marijuana. It remains undisputed that Tom was using the marijuana to treat AIDS, and the side effects of the many potent medications he takes to fight the virus.

Tom takes a total of four antiretroviral drugs to combat the HIV infection: Combivir (a combination of Retrovir and Epivir), Sustiva, and Viread. Each of these drugs, by themselves, come with potentially fatal side effects. All of these drugs can cause severe nausea, and can result in extreme anxiety as an additional side effect. In addition, Tom has been prescribed Marinol, the synthetic THC drug to combat nausea and vomiting, so there is no question that he suffers the side effects which are treated by marijuana, and there is no question that his side effects are severe based upon his dosage. However, Tom says that the marijuana is far more effective than the Marinol, since Marinol makes him so tired that he cannot function; and his physician is aware of and supports his use of marijuana to treat his symptoms.

Tom, though he has no prior criminal record with the exception of two prior misdemeanor convictions for possession of small amounts of marijuana - both of which occurred after he was diagnosed with AIDS - pled guilty to felony possession of marijuana. He faces a maximum of two years in prison, and a maximum fine of $4000; he could also be given probation. His sentencing date has been set for April 21st, before the Honorable Jerome Eckrich, Circuit Judge. Tom's Infectious Disease Specialist, Dr. Traub, will speak at the sentencing hearing. The State Attorney has already said that he will not object to anything Dr. Traub might say. It appears that no one is interested in punishing Tom Faltynowicz; at the same time, under the law, his possession of marijuana - regardless of the reason why he possessed it - is a felony in the state of South Dakota.

Tom, however, is an exception to the reason that law was written. It was written to stop people from abusing the drug to get high, and to stop them from selling or otherwise providing it to others for the same illicit purpose. It is extremely doubtful the legislature was aware of the medicinal effects of marijuana when that law was passed, and it's extremely doubtful the legislature ever intended to punish patients with a deadly disease. It's even possible that the medicinal effects of marijuana were unknown to them when that law was passed, since it is hardly a new law. Nevertheless, since the law exists, it will be enforced, even against people like Tom who are using marijuana strictly for medicinal purposes.

This raises a number of questions. Even if Tom is merely placed on probation, and even if he stopped smoking marijuana altogether, using Marinol to control his symptoms would result in violation of probation, since he would test positive for THC during required drug tests. If he fails a drug test while on probation, he will be incarcerated.

If he is incarcerated, he will not only not have access to the drug which he needs to survive without excessive suffering due to overwhelming nausea, vomiting, physical wasting, and extreme fatigue; but the South Dakota Department of Corrections will be forced to pay for the extremely expensive antiretroviral drugs which fight the virus as well as the Marinol, at a cost of thousands of dollars per month to the taxpayers, in addition to the increased cost of incarceration for a man with an infectious deadly disease. As you should understand after my explanation of how those drugs work, and how the virus works, missing even one dose of his antiretroviral drugs could be catastrophic for his health, since it would allow the virus to replicate until the drug was again built up to a therapeutic dosage. Yet in a prison environment there is no guarantee that he will receive his life-sustaining medications at all, much less receive them on the schedule those drugs demand.

Tom has said that he will not stop using marijuana, because it allows him to live a relatively normal life. Without it, his body is wracked with pain, nausea, and vomiting; he is unable to eat or drink, and thus his body becomes even more weakened, even more unable to fight the virus, and even more prone to the many opportunistic illnesses, any one of which could easily end his life. This is especially true if he is confined in a jail or prison facility, given that there are large numbers of inmates living in close approximation.

To incarcerate Tom Faltynowicz would therefore place his life at severe risk, and as such would clearly constitute cruel and unusual punishment, as prohibited by the Eighth Amendment of the US Constitution. Furthermore, it would serve no purpose to incarcerate him, since his crime is merely possession of a drug which allows him to live with his disease and to continue take the cruel medications which literally keep him alive. He poses no threat to anyone and he is not selling or otherwise distributing the marijuana, nor has it even been suggested that he is selling or distributing the marijuana. Rehabilitation is also not a valid cause for his incarceration, since he merely uses the drug for medicinal purposes, and thus he is not in need of rehabilitation.

Society would not be served by incarcerating Tom Faltynowicz. The interests of justice would not be served by incarcerating Tom Faltynowicz.

As such, justice demands that the court show mercy by giving Tom Faltynowicz a suspended sentence, no probation, and whatever fine the court sees fit, as long as it is within Tom's ability to pay said fine.  The courts should also order the return of Tom's property; police seized property such as lights, and not just marijuana and implements for its use.  Those lights  should be returned.

Global spending for HIV vaccine research increased from $186 million in 1997 to $759 million in 2005, according to the Joint United Nations Program on HIV/AIDS. The IAVI helped to move the field forward by establishing research consortia so that investigators could more easily coordinate and exchange information. The group partnered with governments and vaccine makers to conduct trials outside the U.S., which account for nearly half of the 30-plus trials currently in progress. The NIH formed its own HIV vaccine trial network in 2000 to oversee clinical research sites in the U.S., Africa, Asia, the Caribbean and South America.

The scale of the effort reflects the scientific challenges. In the early 1980s, after identifying the HIV virus as the cause of AIDS, researchers were at first confident that they could come up with a vaccine against it within a few years, Koff says. Vaccines work by exposing the body to a disease-causing agent or a fragment of it. That exposure primes the immune system to produce a flood of antibodies that stick to the infecting organism and block it from entering cells. Researchers identified a protein on the surface of HIV, dubbed gp120, that enables the virus to infect and then slowly destroy so-called helper T cells, which regulate immune responses. The gp120 protein seemed like a good candidate for an HIV vaccine.

Read this entire fascinating article from Scientific American here.

The Orphan Drug Act was designed to provide incentives to companies to develop drugs that treat conditions affecting 200,000 or fewer patients annually in the U.S. and that provide a significant therapeutic advantage over existing treatments or fill an unmet medical need. Orphan drug designation entitles ViroPharma to seven years of market exclusivity in the United States upon FDA approval of maribavir, provided that the company continues to meet certain conditions established by the FDA. Other potential advantages include protocol assistance, the potential for priority review, tax credits, and other financial incentives.

"We are particularly pleased to receive orphan designation for the product from the FDA," commented Colin Broom, M.D., ViroPharma's chief scientific officer. "We have made excellent progress with maribavir over the last 12 months. We demonstrated in a Phase 2 clinical trial that the drug appears to be well tolerated with impressive anti-CMV activity in stem cell transplant patients, which has allowed us to initiate our international Phase 3 development program. The receipt of this designation marks one more important milestone in the development of the compound. Maribavir is an important Phase 3 drug candidate for a significant unmet medical need, and may one day provide an effective and well tolerated therapeutic alternative for patients at risk of CMV disease."

About Maribavir

Maribavir is a potent and selective, orally bioavailable antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable early clinical safety profile. It is a potent member of a new class of drugs called benzimidazole ribosides. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, maribavir inhibits viral DNA assembly and egress of viral capsids from the nucleus of infected cells. Maribavir is also active in vitro against strains of CMV that are resistant to commonly used anti-CMV drugs.

About Cytomegalovirus

CMV is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50% and 85% of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals including cancer patients, HIV patients, and transplant patients, and in children born with primary CMV infection, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.

About ViroPharma Incorporated

ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R) approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin- resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/Vancocin_pi_2007.htm). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the Company's website at http://www.viropharma.com/.

Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including those relating to our hope that maribavir may offer transplant patients a better tolerated, efficacious treatment option. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The development and commercialization of pharmaceutical products is subject to risks and uncertainties. There can be no assurance that that maribavir will ever be approved by the FDA. These factors, and other factors, including, but not limited to those described in ViroPharma's quarterly report on Form 10-Q for the quarters ended March 31, 2006, June 30, 2006 and September 30, 2006 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.

ViroPharma Incorporated
http://www.viropharma.com/

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.

The reduction of virus levels in the blood stream of these AIDS virus-infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.

"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."

The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.

The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.

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These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.

Safe Harbor Statement

All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.

Contact: Melanie Nimrodi
Financial Relati