Should we be concerned in the world of HIV?
Human Growth Hormone (Serostim) is currently approved for HIV wasting. DHEA is a supplement sold over the counter.
Currently, growth hormone is a class IV drug ( no triplicate or DEA number required for prescribing it). DHEA is an over the counter supplement not shown to increase testosterone at all in men, but they will try to stop its sale over the counter...
http://news.yahoo.com/s/ap/20071218/ap_on_go_co/congress_steroids
"The bill by Sen. Charles Schumer, D-N.Y., would classify HGH as a "Schedule III" substance, equating it legally with anabolic steroids and bringing it under the watch of the Drug Enforcement Administration.
A second proposal by Sen. Charles Grassley, R-Iowa, would make it illegal to sell dehydroepiandrosterone (DHEA) to anyone under 18. DHEA is a naturally occurring precursor to testosterone and a dietary supplement that some athletes are using as an alternative to illegal anabolic steroids, Grassley said."
-
The untold Side of the movie "Dallas Buyers Club"
The movie Dallas Buyers Club brings attention to a little-recognized part of the AIDS activist movement: ....
-
Exhorbitant Price New Hepatitis C Drug
Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™...
-
Six Promising HIV Drugs in the Pipeline (2013-2014)
What new HIV medications do we have to look forward to over the next few years? How will these newer drugs improve upon the older ones? To shed some light on these questions....
-
What Can We Look Forward to in HIV Cure Research
TheBodyPRO.com's Nelson Vergel sat down with leading HIV cure research activist Richard Jefferys for an update on current important aspects, and controversies, in HIV cure research....
-
What Supplements Can I take with HIV medications?
Is it ok to supplement with Creatine (Cell-Tech), and Protein (Nitro-Tech) along with Glutamine...
Tuesday, December 18, 2007
Friday, December 14, 2007
Testosterone Pellets for More Sustained and Longer Term Blood Testosterone Levels
I just got back from seeing Dr Richard Cavender in New Albany, OH (ammedicalcenter.com) which is close to Columbus. This man has a full wellness clinic like I have always envisioned with exercise equipment that collects your progress data and feeds it wirelessly to a computer for tracking purposes. He also provides hormone replacement and nutritional support. He has a doctor in exercise physiology, physical therapists, registered dietitians, and a psychologist. He has a very charming personality and treats his patients like equals. Great concept and ahead of his time.
He inserted 12 75- mg testosterone pellets (Testopel) under my skin in the upper gluts area. No discomfort and no pain. He has been using them for years and he says most people can sustain proper testosterone levels for 4-6 months. We took baseline blood work and I will do them again in a month and then 3 months after that to see how I respond.
I have been using testosterone for 15 years now without any side effects. However, my busy travel schedule sometimes gets in the way of perfect adherence to gels or shots, so I decided I would give this a try. Bad adherence to testosterone delivery methods can cause swings in mood and energy levels, so I definitely want more constant testosterone levels!
I will let you know when I get my next testosterone level results.
He inserted 12 75- mg testosterone pellets (Testopel) under my skin in the upper gluts area. No discomfort and no pain. He has been using them for years and he says most people can sustain proper testosterone levels for 4-6 months. We took baseline blood work and I will do them again in a month and then 3 months after that to see how I respond.
I have been using testosterone for 15 years now without any side effects. However, my busy travel schedule sometimes gets in the way of perfect adherence to gels or shots, so I decided I would give this a try. Bad adherence to testosterone delivery methods can cause swings in mood and energy levels, so I definitely want more constant testosterone levels!
I will let you know when I get my next testosterone level results.
Tuesday, November 27, 2007
HIV Metabolic Complications Myths
HIV Metabolic Complications MythsSome misunderstandings about treatment
by David Alain Wohl, M.D.
Introduction
One of the greatest drags on the success of potent antiretroviral (ARV) therapy has been the fear of metabolic complications associated with these medications. Disfiguring body shape changes including the loss of fat in the face, as well as unhealthy cholesterol and triglyceride levels and pre-diabetes are troublesome counter-balances to the euphoria that arose when these drugs arrived and people stopped dying. Even as ARVs have become more user-friendly—less pills, less frequent dosing, less diarrhea and nausea—the specter of metabolic problems can still overshadow these advances, leading those in need of therapy to hesitate when ARVs are recommended. For those already on treatment, metabolic disorders may prompt a change in therapy or lead to the prescription of even more medication and can raise the volume of the little voice that says it is okay to skip doses.
A major frustration for people living with HIV and their health care providers has been a lack of information regarding the cause of metabolic problems during HIV infection and ways to prevent and treat them. The field of metabolic complications of HIV and its therapies is relatively young and much has been learned during a short period of time but some conclusions have been reached with little supportive data. Below is a list of some of the most common of these metabolic complications myths. Myths that emerged in a data vacuum and that even people in the “HIV-know” often still accept. Fortunately, over the past few years a slew of studies has painted a clearer picture of these changes and together suggest that some of our closely-held beliefs about the risks for metabolic complications have been wrong. Understanding that these assumptions are no longer valid, and why, is essential if people living with this infection and their health care providers are to make informed decisions about their care.
Myth #1: Protease inhibitors are responsible for the increases in belly fat.
Like many myths, this one is based on a truth that has been stretched to extremes. People taking protease inhibitors can see an increase in their belly fat, both the deep down fat that surrounds our internal organs and the surface, pinch-an-inch fat so abundant in our land of amber waves of grain. But protease inhibitors hold no monopoly on an ability to expand trunk fat. Studies of efavirenz (Sustiva) have shown that people taking this non-nucleoside also tend to have increases in belly fat. In fact, increases in waist size have been seen in studies of every HIV regimen in which body shape has been objectively measured. For example, in a federally funded AIDS Clinical Trials Group (ACTG) clinical trial called study A5142 comparing the popular HIV medications lopinavir/ritonavir (Kaletra) and efavirenz, trunk fat was seen to increase in participants regardless of which drug they were assigned. Similarly, a Bristol-Myers Squibb sponsored head-to-head study of efavirenz and another protease inhibitor, atazanavir (Reyataz), in patients who were starting HIV therapy also found that both drugs when combined with zidovudine and lamivudine (Retrovir and Epivir, also Combivir) tended to increase abdominal fat over time. Interestingly, a recent Abbott Laboratories study that looked at using lopinavir/ritonavir by itself (i.e. monotherapy) in patients started on this protease inhibitor and zidovudine/lamivudine found that these patients experienced increases in belly fat to the same extent as a control group of patients who were maintained on zidovudine/lamivuine and efavirenz. Therefore, it looks like both protease inhibitors and, at least, the non-nucleoside efavirenz can lead to gains in belly fat.
A problem for most all of these studies is that they rely on a special type of scan called a DEXA to measure abdominal fat. This scan, commonly used to also measure bone density, cannot tell the difference between the deep and surface fat. So, one therapy could be causing accumulation of the deeper fat while another could be associated with surface fat. CT and MRI scans, however, can differentiate deep and surface fat. Unfortunately, we do not have much data regarding the relative changes in fat in deep and surface fat for most HIV regimens. Clearly, more studies need to be done on other regimens, including those that contain newer drugs, and should use CT scans when possible but one thing is clear: when it comes to increasing belly fat, protease inhibitors are not unique.
Myth #2: People who get bigger bellies on HIV meds typically also lose fat in their arms and legs.
As if a big spare tire was not bad enough, some people taking HIV medications also experience loss of fat of the arms, legs, and face. The image of an apple-shaped body with skinny limbs is a frightening one that further turns many people off to HIV therapy. However, it has become clear that most people on HIV medications do not develop this body shape. In fact, a couple of studies of people starting a variety of HIV regimens have found that for most people limb and belly fat tend to increase or decrease together. That is, if someone experiences a gain in belly fat then they are more likely to also experience a gain rather than a loss in limb fat. In one study, only a quarter of people experienced a loss of arm and leg fat while gaining abdominal fat.
Most studies suggest that overall fat gain is a major problem for HIV-positive people. As in the general population, being overweight and obese is common. In a study of HIV-infected patients receiving care in Philadelphia, rates of being overweight and obesity were more of a problem than weight loss. As people with HIV infection look to decades of living with their infection, the problem of obesity is likely to take its toll since obesity increases the risk of diabetes, heart disease and death.
Myth #3: Loss of limb fat during HIV therapy only occurs when stavudine (d4T) is included in the treatment regimen.
The profound loss of fat within the arms, legs and especially the face among people on HIV medication cocktails that was seen in the mid-1990s was quickly associated with one drug, stavudine (Zerit). The link between such disfigurement and this drug was so obvious that use of stavudine in the U.S. and Europe quickly fell and is now rarely prescribed (unfortunately, stavudine is still commonly used in developing nations as it is easy to make and, thus, cheap).
The drop in stavudine use was followed by a dramatic reduction in new cases of severe fat loss of the face and limbs. However, over time some doctors and their patients noticed a slower but undeniable depletion of fat in these same areas of the body. But, as these changes were slow to develop and DEXA, CT, and MRI scans are not routinely performed in clinics to measure and follow body fat changes, it was unclear whether these changes were real and, if so, what caused them. What was clear was that these people seemed to be losing limb and face fat but had never taken stavudine.
Some answers came from clinical trials that incorporated DEXA scans into their design. One study done several years ago by the ACTG found that people starting HIV therapy who took the protease inhibitor nelfinavir (Viracept) were more likely to lose limb fat—as measured by DEXA scans—than those taking efavirenz, even when the other medication taken was limited to zidovudine/lamivudine (Combivir). This meant that people on zidovudine/lamivudine were experiencing fat loss and that this was accelerated with nelfinavir use. Another study comparing zidovudine/lamivudine with tenofovir/emtricitabine (Truvada) when both were taken with efavirenz found that there was a progressive loss of fat among those assigned to zidovudine/lamivudine while those taking tenofovir/emtricitabine gained limb fat over time.
The ACTG study A5142 looking at people new to HIV medications also performed DEXA scans before HIV medications were initiated and then at regular intervals after starting the drugs. This was a large study of almost 750 people who were assigned to one of three different study treatments: a.) lopinavir/ritonavir plus two nucleosides, or b.) efavirenz plus two nucleosides, or c.) lopinavir/ritonavir plus efavirenz alone without nucleosides. Those taking nucleosides could use only lamivudine plus either stavudine, zidovudine or tenofovir (Viread). The study is very important as efavirenz and lopinavir/ritonavir are two of the most popular medications used to treat HIV infection yet, had never been compared before. The results of this trial have shaken the field of body shape changes during HIV treatment. Those taking stavudine had, as expected, the greatest loss of limb fat and those taking tenofovir had the least. But, zidovudine fell in between. This alone indicated that some people experienced limb fat loss even when not receiving stavudine and that zidovudine was capable of doing this to a greater extent than many had thought. In addition, the study found that no matter what nucleoside was used, efavirenz was more likely to cause significant fat loss compared to lopinavir/ritonavir. That is, efavirenz seemed to add to the fat loss that was associated with the nucleosides. The good news is that few of those on tenofovir lost significant amounts of limb fat at 96 weeks of study, even when on efavirenz, so fear of fat loss should not be a major concern for those who are taking or considering use of tenofovir plus efavirenz (two of the three medications in Atripla).
Taken together, these data indicate that fat loss of the arms and legs is not limited to stavudine and that other drugs can also produce these changes. Zidovudine appears to be worse than tenofovir (or abacavir [Ziagen]), albeit it is not as bad as stavudine. Additionally, efavirenz seems to be able to dial-up the fat loss effect of nucleosides to a greater extent than lopinavir/ritonavir. Unfortunately, there is not much information regarding face fat from any of these studies.
Myth #4: Sit-ups can spot reduce belly fat.This myth falls into the same category as the belief that going out with wet hair will increase your risk for a death of a cold and that too much time spent self-pleasuring can wreak havoc on your visual acuity. A remarkable number of intelligent men and women arrive at their clinic visits complaining of increases in belly fat, and are frustrated that endless sit-ups have done nothing to reduce their mid-body girth.
Sit-ups, when done properly, can increase strength in the abdominal muscles. This leads to firmer muscles and an increase in core strength but will not melt away fat in that one area. Fat is lost when more energy is expended than taken in. While sit-ups require energy, they do not preferentially draw that energy from the deposit of fat cells found in those love handles. A better approach is to combine sit-ups with aerobic exercises that require heavy breathing and sweating for prolonged periods of time like running, cycling, stair climbing, rope jumping, etc. Small studies have shown decreases in abdominal fat when HIV-positive people followed a program of aerobic exercise and weight lifting several times a week.
Diet can also play a role here and a smart approach would be to limit simple sugars and the highly caloric fats that make up most of the so-called comfort foods of our society. For most people dietary modification need not be very complicated and can be summed up with a recommendation to greatly increase daily intake of fruits and vegetables, the latter preferably raw or lightly steamed. These are foods that are not packed with excess calories, contain cholesterol-lowering fiber and are filling—leaving less room for the fatty, super-size-me foods at the root of many of our health problems.
In addition to eating like a Buddhist monk and joining a gym there are other interventions that have been studied to reduce excess fat. Unfortunately, few have panned out. Growth hormone is an injectable agent that has been found to reduce fat in the belly and buffalo hump and some people have benefited from this therapy. However, this is an expensive drug that is not usually covered by insurance carriers for the treatment of excess fat. Also, at the doses studied for the treatment of excess fat, growth hormone has been plagued by a number of troublesome side effects including worsening glucose levels, muscle and joint aches, and feet swelling. Interestingly, exercise is known to increase the body’s own production of growth hormone.
Testosterone and other androgens (“male hormones”) have also been studied as treatments for fat accumulation in people with HIV infection. These hormones, like growth hormone, can pop fat cells but in another ACTG study were found to preferentially reduce the surface fat and not the deep fat that made for most of the enlargement of the belly. Androgens can also worsen limb and face fat loss. Therefore, although beloved by many, the data suggest that androgens may do little to reduce abdominal girth and can aggravate loss of fat beyond the trunk.
A few drugs used for the treatment of diabetes have also been studied for fat accumulation, including metformin, rosiglitazone, and pioglitazone. Most of the data informing the use of these drugs in people with HIV come from small studies. Suffice to say that their effects, if present at all, seem to be mostly limited to those with diabetes or a pre-diabetes condition. The underwhelming study results and the toxicities of these medications have diminished any enthusiasm for dedicated use of these drugs to treat fat changes in people with HIV infection.
Myth #5: People with HIV infection have higher cholesterol levels than people without HIV.
Take a survey of people living with HIV or even their docs and ask whether HIVers have higher cholesterol levels than those without HIV. Chances are most would respond that those who are HIV-positive would, on average, have higher levels than those who are uninfected. Actually, at least a couple of studies have found that people with HIV infection tend to have lower levels of LDL cholesterol, the “bad” cholesterol that has been strongly linked to heart disease, than people in general; this finding holds even when including those who are on HIV medications.
This does not mean that those with HIV infection have a better lipid profile than uninfected folks. A major problem is that levels of the “good” cholesterol, HDL cholesterol, are also lower in HIV-positive people. HDL cholesterol has been found to offer protection from heart disease and a low level is an independent risk factor for cardiovascular problems. Exercise and modest alcohol (not just red wine) intake can safely raise HDL cholesterol in some people. In addition, a little appreciated fact is that certain HIV medications also raise HDL cholesterol levels. The non-nucleosides efavirenz and nevirapine [Viramune] and the protease inhibitor atazanavir alone or in combination with ritonavir [Norvir] and most all other protease inhibitors that are boosted with ritonavir have all been found to raise HDL cholesterol levels.
Triglyceride levels, though, are a different story. Triglycerides are broken down in the body from fat and can be found floating free in the blood or in a complex with other lipids and proteins in the form of cholesterol. The more triglycerides in the cholesterol complex, the more dangerous it is in terms of cardiovascular risk with LDL cholesterol having more triglycerides than HDL cholesterol. Fasting triglyceride levels are, on average, higher in people with HIV infection and increases further with HIV therapy. While in some people the level of triglycerides can skyrocket to very concerning levels (greater than 500 mg/dL) most people with HIV infection have levels that are high but not alarming. In addition, by itself the level of triglycerides measured in the blood is not considered as nearly big a risk for cardiovascular disease as high LDL or low HDL cholesterol. Most all HIV regimens can raise triglyceride levels. The ritonavir-boosted protease inhibitors are a bit worse in this regard than efavirenz, and most studies suggest that lopinavir/ritonavir and fos-amprenavir/ritonavir (Lexiva/Norvir) may raise triglyceride levels a bit more than other commonly-used boosted protease inhibitors, but the clinical significance of these modest differences is not clear.
Overall, the data suggest that people with HIV may be at greater risk of cardiovascular problems like heart attacks due to their low HDL cholesterol levels and possibly increases in LDL cholesterol and triglyceride levels during HIV therapy. Additionally, there may be other factors such as inflammation caused by the virus that can lead to chemical changes in the body that can prompt clogging of the arteries. However, it is almost certain that smoking adds much more to the risk of cardiovascular disease than these other HIV-related factors and that of all the things a person with HIV infection could do to survive and thrive, beyond taking HIV medications when necessary, the most significant is to stop smoking.
Summary
Clinicians and their patients do not tolerate ambiguity well. Gaps in knowledge of a disease demand to be filled and when the research data come up short it is difficult not to extrapolate. In the 25 years since the AIDS pandemic ignited, much has been learned about HIV and the crowning achievement of the scientists, clinicians, and advocates dedicated to this disease has been the dramatic reversal of the lethality of this disease. However, in HIV, as in medicine in general, it has been difficult to not jump to conclusions when data are conflicting or just plain not in existence.
In the case of metabolic complications of HIV and its treatments, we have learned to learn. New investigations have revealed the accuracy and inaccuracy of previous assumptions and allow us opportunities to better choose among our options. The trick is we have to be willing to let go of our old beliefs and embrace findings that rigorously challenge these concepts. The old mantra that knowledge=power still holds, but we have to accept that better knowledge=even more power.
Dr. Wohl is an Associate Professor of Infectious Diseases and Co-Director of the AIDS Clinical Trials Unit at the University of North Carolina. Metabolic complications associated with HIV infection and the nexus between HIV and incarceration are his major areas of research interest. He can be reached via e-mail at wohl@med.unc.edu.
by David Alain Wohl, M.D.
Introduction
One of the greatest drags on the success of potent antiretroviral (ARV) therapy has been the fear of metabolic complications associated with these medications. Disfiguring body shape changes including the loss of fat in the face, as well as unhealthy cholesterol and triglyceride levels and pre-diabetes are troublesome counter-balances to the euphoria that arose when these drugs arrived and people stopped dying. Even as ARVs have become more user-friendly—less pills, less frequent dosing, less diarrhea and nausea—the specter of metabolic problems can still overshadow these advances, leading those in need of therapy to hesitate when ARVs are recommended. For those already on treatment, metabolic disorders may prompt a change in therapy or lead to the prescription of even more medication and can raise the volume of the little voice that says it is okay to skip doses.
A major frustration for people living with HIV and their health care providers has been a lack of information regarding the cause of metabolic problems during HIV infection and ways to prevent and treat them. The field of metabolic complications of HIV and its therapies is relatively young and much has been learned during a short period of time but some conclusions have been reached with little supportive data. Below is a list of some of the most common of these metabolic complications myths. Myths that emerged in a data vacuum and that even people in the “HIV-know” often still accept. Fortunately, over the past few years a slew of studies has painted a clearer picture of these changes and together suggest that some of our closely-held beliefs about the risks for metabolic complications have been wrong. Understanding that these assumptions are no longer valid, and why, is essential if people living with this infection and their health care providers are to make informed decisions about their care.
Myth #1: Protease inhibitors are responsible for the increases in belly fat.
Like many myths, this one is based on a truth that has been stretched to extremes. People taking protease inhibitors can see an increase in their belly fat, both the deep down fat that surrounds our internal organs and the surface, pinch-an-inch fat so abundant in our land of amber waves of grain. But protease inhibitors hold no monopoly on an ability to expand trunk fat. Studies of efavirenz (Sustiva) have shown that people taking this non-nucleoside also tend to have increases in belly fat. In fact, increases in waist size have been seen in studies of every HIV regimen in which body shape has been objectively measured. For example, in a federally funded AIDS Clinical Trials Group (ACTG) clinical trial called study A5142 comparing the popular HIV medications lopinavir/ritonavir (Kaletra) and efavirenz, trunk fat was seen to increase in participants regardless of which drug they were assigned. Similarly, a Bristol-Myers Squibb sponsored head-to-head study of efavirenz and another protease inhibitor, atazanavir (Reyataz), in patients who were starting HIV therapy also found that both drugs when combined with zidovudine and lamivudine (Retrovir and Epivir, also Combivir) tended to increase abdominal fat over time. Interestingly, a recent Abbott Laboratories study that looked at using lopinavir/ritonavir by itself (i.e. monotherapy) in patients started on this protease inhibitor and zidovudine/lamivudine found that these patients experienced increases in belly fat to the same extent as a control group of patients who were maintained on zidovudine/lamivuine and efavirenz. Therefore, it looks like both protease inhibitors and, at least, the non-nucleoside efavirenz can lead to gains in belly fat.
A problem for most all of these studies is that they rely on a special type of scan called a DEXA to measure abdominal fat. This scan, commonly used to also measure bone density, cannot tell the difference between the deep and surface fat. So, one therapy could be causing accumulation of the deeper fat while another could be associated with surface fat. CT and MRI scans, however, can differentiate deep and surface fat. Unfortunately, we do not have much data regarding the relative changes in fat in deep and surface fat for most HIV regimens. Clearly, more studies need to be done on other regimens, including those that contain newer drugs, and should use CT scans when possible but one thing is clear: when it comes to increasing belly fat, protease inhibitors are not unique.
Myth #2: People who get bigger bellies on HIV meds typically also lose fat in their arms and legs.
As if a big spare tire was not bad enough, some people taking HIV medications also experience loss of fat of the arms, legs, and face. The image of an apple-shaped body with skinny limbs is a frightening one that further turns many people off to HIV therapy. However, it has become clear that most people on HIV medications do not develop this body shape. In fact, a couple of studies of people starting a variety of HIV regimens have found that for most people limb and belly fat tend to increase or decrease together. That is, if someone experiences a gain in belly fat then they are more likely to also experience a gain rather than a loss in limb fat. In one study, only a quarter of people experienced a loss of arm and leg fat while gaining abdominal fat.
Most studies suggest that overall fat gain is a major problem for HIV-positive people. As in the general population, being overweight and obese is common. In a study of HIV-infected patients receiving care in Philadelphia, rates of being overweight and obesity were more of a problem than weight loss. As people with HIV infection look to decades of living with their infection, the problem of obesity is likely to take its toll since obesity increases the risk of diabetes, heart disease and death.
Myth #3: Loss of limb fat during HIV therapy only occurs when stavudine (d4T) is included in the treatment regimen.
The profound loss of fat within the arms, legs and especially the face among people on HIV medication cocktails that was seen in the mid-1990s was quickly associated with one drug, stavudine (Zerit). The link between such disfigurement and this drug was so obvious that use of stavudine in the U.S. and Europe quickly fell and is now rarely prescribed (unfortunately, stavudine is still commonly used in developing nations as it is easy to make and, thus, cheap).
The drop in stavudine use was followed by a dramatic reduction in new cases of severe fat loss of the face and limbs. However, over time some doctors and their patients noticed a slower but undeniable depletion of fat in these same areas of the body. But, as these changes were slow to develop and DEXA, CT, and MRI scans are not routinely performed in clinics to measure and follow body fat changes, it was unclear whether these changes were real and, if so, what caused them. What was clear was that these people seemed to be losing limb and face fat but had never taken stavudine.
Some answers came from clinical trials that incorporated DEXA scans into their design. One study done several years ago by the ACTG found that people starting HIV therapy who took the protease inhibitor nelfinavir (Viracept) were more likely to lose limb fat—as measured by DEXA scans—than those taking efavirenz, even when the other medication taken was limited to zidovudine/lamivudine (Combivir). This meant that people on zidovudine/lamivudine were experiencing fat loss and that this was accelerated with nelfinavir use. Another study comparing zidovudine/lamivudine with tenofovir/emtricitabine (Truvada) when both were taken with efavirenz found that there was a progressive loss of fat among those assigned to zidovudine/lamivudine while those taking tenofovir/emtricitabine gained limb fat over time.
The ACTG study A5142 looking at people new to HIV medications also performed DEXA scans before HIV medications were initiated and then at regular intervals after starting the drugs. This was a large study of almost 750 people who were assigned to one of three different study treatments: a.) lopinavir/ritonavir plus two nucleosides, or b.) efavirenz plus two nucleosides, or c.) lopinavir/ritonavir plus efavirenz alone without nucleosides. Those taking nucleosides could use only lamivudine plus either stavudine, zidovudine or tenofovir (Viread). The study is very important as efavirenz and lopinavir/ritonavir are two of the most popular medications used to treat HIV infection yet, had never been compared before. The results of this trial have shaken the field of body shape changes during HIV treatment. Those taking stavudine had, as expected, the greatest loss of limb fat and those taking tenofovir had the least. But, zidovudine fell in between. This alone indicated that some people experienced limb fat loss even when not receiving stavudine and that zidovudine was capable of doing this to a greater extent than many had thought. In addition, the study found that no matter what nucleoside was used, efavirenz was more likely to cause significant fat loss compared to lopinavir/ritonavir. That is, efavirenz seemed to add to the fat loss that was associated with the nucleosides. The good news is that few of those on tenofovir lost significant amounts of limb fat at 96 weeks of study, even when on efavirenz, so fear of fat loss should not be a major concern for those who are taking or considering use of tenofovir plus efavirenz (two of the three medications in Atripla).
Taken together, these data indicate that fat loss of the arms and legs is not limited to stavudine and that other drugs can also produce these changes. Zidovudine appears to be worse than tenofovir (or abacavir [Ziagen]), albeit it is not as bad as stavudine. Additionally, efavirenz seems to be able to dial-up the fat loss effect of nucleosides to a greater extent than lopinavir/ritonavir. Unfortunately, there is not much information regarding face fat from any of these studies.
Myth #4: Sit-ups can spot reduce belly fat.This myth falls into the same category as the belief that going out with wet hair will increase your risk for a death of a cold and that too much time spent self-pleasuring can wreak havoc on your visual acuity. A remarkable number of intelligent men and women arrive at their clinic visits complaining of increases in belly fat, and are frustrated that endless sit-ups have done nothing to reduce their mid-body girth.
Sit-ups, when done properly, can increase strength in the abdominal muscles. This leads to firmer muscles and an increase in core strength but will not melt away fat in that one area. Fat is lost when more energy is expended than taken in. While sit-ups require energy, they do not preferentially draw that energy from the deposit of fat cells found in those love handles. A better approach is to combine sit-ups with aerobic exercises that require heavy breathing and sweating for prolonged periods of time like running, cycling, stair climbing, rope jumping, etc. Small studies have shown decreases in abdominal fat when HIV-positive people followed a program of aerobic exercise and weight lifting several times a week.
Diet can also play a role here and a smart approach would be to limit simple sugars and the highly caloric fats that make up most of the so-called comfort foods of our society. For most people dietary modification need not be very complicated and can be summed up with a recommendation to greatly increase daily intake of fruits and vegetables, the latter preferably raw or lightly steamed. These are foods that are not packed with excess calories, contain cholesterol-lowering fiber and are filling—leaving less room for the fatty, super-size-me foods at the root of many of our health problems.
In addition to eating like a Buddhist monk and joining a gym there are other interventions that have been studied to reduce excess fat. Unfortunately, few have panned out. Growth hormone is an injectable agent that has been found to reduce fat in the belly and buffalo hump and some people have benefited from this therapy. However, this is an expensive drug that is not usually covered by insurance carriers for the treatment of excess fat. Also, at the doses studied for the treatment of excess fat, growth hormone has been plagued by a number of troublesome side effects including worsening glucose levels, muscle and joint aches, and feet swelling. Interestingly, exercise is known to increase the body’s own production of growth hormone.
Testosterone and other androgens (“male hormones”) have also been studied as treatments for fat accumulation in people with HIV infection. These hormones, like growth hormone, can pop fat cells but in another ACTG study were found to preferentially reduce the surface fat and not the deep fat that made for most of the enlargement of the belly. Androgens can also worsen limb and face fat loss. Therefore, although beloved by many, the data suggest that androgens may do little to reduce abdominal girth and can aggravate loss of fat beyond the trunk.
A few drugs used for the treatment of diabetes have also been studied for fat accumulation, including metformin, rosiglitazone, and pioglitazone. Most of the data informing the use of these drugs in people with HIV come from small studies. Suffice to say that their effects, if present at all, seem to be mostly limited to those with diabetes or a pre-diabetes condition. The underwhelming study results and the toxicities of these medications have diminished any enthusiasm for dedicated use of these drugs to treat fat changes in people with HIV infection.
Myth #5: People with HIV infection have higher cholesterol levels than people without HIV.
Take a survey of people living with HIV or even their docs and ask whether HIVers have higher cholesterol levels than those without HIV. Chances are most would respond that those who are HIV-positive would, on average, have higher levels than those who are uninfected. Actually, at least a couple of studies have found that people with HIV infection tend to have lower levels of LDL cholesterol, the “bad” cholesterol that has been strongly linked to heart disease, than people in general; this finding holds even when including those who are on HIV medications.
This does not mean that those with HIV infection have a better lipid profile than uninfected folks. A major problem is that levels of the “good” cholesterol, HDL cholesterol, are also lower in HIV-positive people. HDL cholesterol has been found to offer protection from heart disease and a low level is an independent risk factor for cardiovascular problems. Exercise and modest alcohol (not just red wine) intake can safely raise HDL cholesterol in some people. In addition, a little appreciated fact is that certain HIV medications also raise HDL cholesterol levels. The non-nucleosides efavirenz and nevirapine [Viramune] and the protease inhibitor atazanavir alone or in combination with ritonavir [Norvir] and most all other protease inhibitors that are boosted with ritonavir have all been found to raise HDL cholesterol levels.
Triglyceride levels, though, are a different story. Triglycerides are broken down in the body from fat and can be found floating free in the blood or in a complex with other lipids and proteins in the form of cholesterol. The more triglycerides in the cholesterol complex, the more dangerous it is in terms of cardiovascular risk with LDL cholesterol having more triglycerides than HDL cholesterol. Fasting triglyceride levels are, on average, higher in people with HIV infection and increases further with HIV therapy. While in some people the level of triglycerides can skyrocket to very concerning levels (greater than 500 mg/dL) most people with HIV infection have levels that are high but not alarming. In addition, by itself the level of triglycerides measured in the blood is not considered as nearly big a risk for cardiovascular disease as high LDL or low HDL cholesterol. Most all HIV regimens can raise triglyceride levels. The ritonavir-boosted protease inhibitors are a bit worse in this regard than efavirenz, and most studies suggest that lopinavir/ritonavir and fos-amprenavir/ritonavir (Lexiva/Norvir) may raise triglyceride levels a bit more than other commonly-used boosted protease inhibitors, but the clinical significance of these modest differences is not clear.
Overall, the data suggest that people with HIV may be at greater risk of cardiovascular problems like heart attacks due to their low HDL cholesterol levels and possibly increases in LDL cholesterol and triglyceride levels during HIV therapy. Additionally, there may be other factors such as inflammation caused by the virus that can lead to chemical changes in the body that can prompt clogging of the arteries. However, it is almost certain that smoking adds much more to the risk of cardiovascular disease than these other HIV-related factors and that of all the things a person with HIV infection could do to survive and thrive, beyond taking HIV medications when necessary, the most significant is to stop smoking.
Summary
Clinicians and their patients do not tolerate ambiguity well. Gaps in knowledge of a disease demand to be filled and when the research data come up short it is difficult not to extrapolate. In the 25 years since the AIDS pandemic ignited, much has been learned about HIV and the crowning achievement of the scientists, clinicians, and advocates dedicated to this disease has been the dramatic reversal of the lethality of this disease. However, in HIV, as in medicine in general, it has been difficult to not jump to conclusions when data are conflicting or just plain not in existence.
In the case of metabolic complications of HIV and its treatments, we have learned to learn. New investigations have revealed the accuracy and inaccuracy of previous assumptions and allow us opportunities to better choose among our options. The trick is we have to be willing to let go of our old beliefs and embrace findings that rigorously challenge these concepts. The old mantra that knowledge=power still holds, but we have to accept that better knowledge=even more power.
Dr. Wohl is an Associate Professor of Infectious Diseases and Co-Director of the AIDS Clinical Trials Unit at the University of North Carolina. Metabolic complications associated with HIV infection and the nexus between HIV and incarceration are his major areas of research interest. He can be reached via e-mail at wohl@med.unc.edu.
We need action by Dec 6!:A Bush double-cross on HIV travel ban
Background:
A Bush double-cross on HIV travel ban
Tuesday, November 20, 2007
The Bush administration is trying to pull a fast one rushing through draconian proposed new regulations that will restrict even further the entry of HIV-positive people into to the US, just one year after having promised to ease them.
By Doug Ireland
The Bush administration is trying to pull a fast one rushing through draconian proposed new regulations that will restrict even further the entry of HIV-positive people into to the US, just one year after having promised to ease them.
On November 6, the Department of Homeland Security (DHS) issued stringent proposed new regulations for HIV-positive travelers coming here which are pretty regressive and extremely troubling, according to Nancy Ordover, assistant director for federal affairs and research at the Gay Mens Health Crisis (GMHC).
But the 30-day deadline for public comment imposed by DHS means a cut-off date of December 6 for reactions to the new regs, leaving little time for the AIDS advocacy community to mobilize.
That, Ordover told Gay City News, is a departure from standard practice for proposed new federal regulations; the time frame for public reaction is usually much longer, she said.
The US is one of only 13 countries that completely ban incoming travel across their borders by the HIV-positive. The others, according to a list established by the leading German AIDS service organization, Deutsche AIDS Hillfe, for the most part have undemocratic regimes. They are Iraq, China, Saudi Arabia, Libya, Sudan, Qatar, Brunei, Oman, Moldova, Russia, Armenia, and South Korea.
A waiver to the ban is required for HIV-positive travelers to or through the US. Even when a travelers US stay merely involves changing planes, a waiver is needed.
Last year on World AIDS Day, President George W. Bush pledged to issue streamlined new regulations with a categorical waiver that would make it easier for the HIV-positive to receive exemptions.
Unfortunately, despite using the terms streamlined and categorical, in reality these regulations are neither, said Victoria Neilson, legal director of Immigration Equality, which works on behalf of LGBT and HIV-positive asylum seekers and immigrants.
Neilson told Gay City News, This is a big disappointment, given the rhetoric of the Bush administration that the US was making it easier because the new regs simply add more heavy burdens for the HIV-positive traveler.
Among other provisions, under the new rules proposed by DHS, a visitor would need to travel with all the medication he would need during his stay in the US; prove that he has medical insurance that is accepted in the US and would cover any medical contingency; and prove that he wont engage in behavior that might put the American public at risk. The maximum term for any waiver would be 30 days.
The new regulations purport to speed up the waiver application process because consular officers would be empowered to make decisions without seeking DHS sign-off. However, by using this streamlined application process, waiver applicants would have to agree to give up the ability to apply for any change in status while in the US, including applying for legal permanent residence.
The purpose of fast-tracking the new regs and setting a super-tight December 6 deadline for public comment before they take effect was to catch the AIDS community busy with preparations for World AIDS Day on December 1 unawares. To a certain extent, the ploy has worked.
When Gay City News telephoned the usually well-informed Kate Krauss who has worked for several AIDS advocacy organizations and now coordinates the Health Action AIDS Campaign for Physicians for Human Rights to find out what she thought of the proposed new regs, she hadnt yet heard of them.
Wow, they just flew right by me they havent been on my radar screen at all, she said.
After having been provided by Gay City News with a copy of the proposal, Krauss was appalled.
Under the proposed regulations, the US travel ban remains a cruel violation of human rights for people with AIDS, Krauss said, adding, People with HIV would be made to jump through even more hoops than before, and the rules would make it particularly difficult for people from very poor nations to visit the US, with requirements for wealth, medical care, medications, and documentation that the applicant is HIV-positive.
Moreover, Krauss said, People could be penalized if they became sick while visiting the United States and, if found to be out of compliance with these regulations, barred from ever visiting the US again. If President Bush cares about the human rights of people with AIDS, he should just ask Congress to abolish the travel ban. Anything else is just rewriting an unjust policy.
GMHCs Ordover pointed out, As written, the rule could leave individuals with HIV who obtain asylum in the US in a permanent limbo; forever barred from obtaining legal permanent residence, and therefore cut off from services, benefits, and employment opportunities.
Ordover added, It seems very disingenuous that the government is claiming to make things easier for people with HIV, but its really compelling them to forfeit their rights.
As a result of the hasty release of the proposed regs and the arbitrarily truncated time frame for public comment, only a few AIDS advocacy organizations have so far taken a critical posture, and this only began to happen at the end of last week.
GMHC was the first organization to release a lengthy analysis of the new regs, which it did last Friday, and began preparing a sign-on statement protesting them which it will ask other AIDS advocacy groups and immigrant rights organizations to join.
But things were fairly sluggish at AIDS Action Council, the largest Washington, DC AIDS lobby, which bills itself as the national voice on AIDS and represents more than 3,000 local service organizations. When Gay City News this Monday asked Ronald Johnson, AIDS Actions deputy executive director, for his organizations position on the new regs, he would only say, we are in the process of developing our comments and we are still looking at the fine print.
Johnson added, Well probably follow GMHCs analysis.
When this reporter suggested to Johnson that AIDS Action organize a national conference call with executive directors of AIDS advocacy organizations to mobilize them quickly against the harsh new regs, he said theyd think about it.
Fortunately, GMHC is already in the process of organizing such a conference call for next week, Ordover told Gay City News.
However, said Ordover, these regulations are in general a distraction what we really need to move forward on is getting the HIV-positive travel bar overturned completely.
In addition to her other duties at GHMC, Ordover is co-coordinator of Lift the Bar, a coalition of HIV, immigrant, human rights, and LGBT service and advocacy organizations working to overturn the HIV ban.
At a Congressional hearing last November, Ordover detailed the negative consequences of the travel ban.
The HIV bar rarely makes the news, and when we do hear about it, its usually because someone trying to attend some major event or forum being held in the US cant get into the country, Ordover said. This is not unimportant the International AIDS Conference hasnt been held on US soil for 16 years and the HIV bar is the reason. Despite our efforts in the global fight against HIV and AIDS, our standing in the international community has been grievously compromised by this policy.
Ordover, who noted that one-third of GMHCs clients are immigrants, also pointed out, Many people first learn they are HIV-positive after they get to the US. Many contract HIV here. Some find out their status when they get the results of their Immigration Service medical examination.
Under the current DHS regs in force, she said, Visitors either are actively deterred from seeking HIV testing and treatment, or avoid contact with providers out of fear of putting their immigration status in permanent limbo or worse. If they are low-income or poor, they either dont have recourse to the full slate of public programs and services they need to stay healthy or may be unaware of what services they are entitled to. At GMHC we view this policy as a violation of human rights and a threat to public health inside and outside the US. The proposed new regs do nothing to change this.
And, Ordover added, The truth is, the bar undermines public health and drives up the cost of health care. It forces HIV-positive immigrants to go underground, discourages immigrants who dont know their status from getting tested, from seeking preventive care, from seeking any care until they end up in the emergency room with full blown AIDS all things that undermine individual health, public health and that ultimately put more strain on the public coffers.
Individuals who wish to protest the harsh new DHS regs on HIV-positive travel may submit comments online at click - but to do so you must include the docket number of the proposed regs, USCBP-2007-0084. Organizations wishing to join in signing on to the statement GMHC is preparing in protest of the new regs should contact Nancy Ordover at nancyo@gmhc.org or 212-367-1240. Doug Ireland can be reached through his blog, DIRELAND, at click.
SOURCE: Gay City News
http://www.gaycitynews.com/site/news.cfm?newsid=19044628&BRD...
This is the proposed rule
http://federalregistersearch.com/2007/11/6/E7-21841.asp
Submitted comments should be mailed to:
Border Security Regulations Branch, Customs and Border Protection, 1300 Pennsylvania Avenue, NW. (Mint Annex), Washington, DC 20229.
Include this in your letter:
Reference:
[Federal Register: November 6, 2007 (Volume 72, Number 214)]
[Proposed Rules]
[Page 62593-62600]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no07-15]
DEPARTMENT OF HOMELAND SECURITY
Bureau of Customs and Border Protection
8 CFR Parts 100 and 212
[USCBP-2007-0084]
RIN 1651-AA71
"Issuance of a Visa and Authorization for Temporary Admission Into
the United States for Certain Nonimmigrant Aliens Infected With HIV"
A Bush double-cross on HIV travel ban
Tuesday, November 20, 2007
The Bush administration is trying to pull a fast one rushing through draconian proposed new regulations that will restrict even further the entry of HIV-positive people into to the US, just one year after having promised to ease them.
By Doug Ireland
The Bush administration is trying to pull a fast one rushing through draconian proposed new regulations that will restrict even further the entry of HIV-positive people into to the US, just one year after having promised to ease them.
On November 6, the Department of Homeland Security (DHS) issued stringent proposed new regulations for HIV-positive travelers coming here which are pretty regressive and extremely troubling, according to Nancy Ordover, assistant director for federal affairs and research at the Gay Mens Health Crisis (GMHC).
But the 30-day deadline for public comment imposed by DHS means a cut-off date of December 6 for reactions to the new regs, leaving little time for the AIDS advocacy community to mobilize.
That, Ordover told Gay City News, is a departure from standard practice for proposed new federal regulations; the time frame for public reaction is usually much longer, she said.
The US is one of only 13 countries that completely ban incoming travel across their borders by the HIV-positive. The others, according to a list established by the leading German AIDS service organization, Deutsche AIDS Hillfe, for the most part have undemocratic regimes. They are Iraq, China, Saudi Arabia, Libya, Sudan, Qatar, Brunei, Oman, Moldova, Russia, Armenia, and South Korea.
A waiver to the ban is required for HIV-positive travelers to or through the US. Even when a travelers US stay merely involves changing planes, a waiver is needed.
Last year on World AIDS Day, President George W. Bush pledged to issue streamlined new regulations with a categorical waiver that would make it easier for the HIV-positive to receive exemptions.
Unfortunately, despite using the terms streamlined and categorical, in reality these regulations are neither, said Victoria Neilson, legal director of Immigration Equality, which works on behalf of LGBT and HIV-positive asylum seekers and immigrants.
Neilson told Gay City News, This is a big disappointment, given the rhetoric of the Bush administration that the US was making it easier because the new regs simply add more heavy burdens for the HIV-positive traveler.
Among other provisions, under the new rules proposed by DHS, a visitor would need to travel with all the medication he would need during his stay in the US; prove that he has medical insurance that is accepted in the US and would cover any medical contingency; and prove that he wont engage in behavior that might put the American public at risk. The maximum term for any waiver would be 30 days.
The new regulations purport to speed up the waiver application process because consular officers would be empowered to make decisions without seeking DHS sign-off. However, by using this streamlined application process, waiver applicants would have to agree to give up the ability to apply for any change in status while in the US, including applying for legal permanent residence.
The purpose of fast-tracking the new regs and setting a super-tight December 6 deadline for public comment before they take effect was to catch the AIDS community busy with preparations for World AIDS Day on December 1 unawares. To a certain extent, the ploy has worked.
When Gay City News telephoned the usually well-informed Kate Krauss who has worked for several AIDS advocacy organizations and now coordinates the Health Action AIDS Campaign for Physicians for Human Rights to find out what she thought of the proposed new regs, she hadnt yet heard of them.
Wow, they just flew right by me they havent been on my radar screen at all, she said.
After having been provided by Gay City News with a copy of the proposal, Krauss was appalled.
Under the proposed regulations, the US travel ban remains a cruel violation of human rights for people with AIDS, Krauss said, adding, People with HIV would be made to jump through even more hoops than before, and the rules would make it particularly difficult for people from very poor nations to visit the US, with requirements for wealth, medical care, medications, and documentation that the applicant is HIV-positive.
Moreover, Krauss said, People could be penalized if they became sick while visiting the United States and, if found to be out of compliance with these regulations, barred from ever visiting the US again. If President Bush cares about the human rights of people with AIDS, he should just ask Congress to abolish the travel ban. Anything else is just rewriting an unjust policy.
GMHCs Ordover pointed out, As written, the rule could leave individuals with HIV who obtain asylum in the US in a permanent limbo; forever barred from obtaining legal permanent residence, and therefore cut off from services, benefits, and employment opportunities.
Ordover added, It seems very disingenuous that the government is claiming to make things easier for people with HIV, but its really compelling them to forfeit their rights.
As a result of the hasty release of the proposed regs and the arbitrarily truncated time frame for public comment, only a few AIDS advocacy organizations have so far taken a critical posture, and this only began to happen at the end of last week.
GMHC was the first organization to release a lengthy analysis of the new regs, which it did last Friday, and began preparing a sign-on statement protesting them which it will ask other AIDS advocacy groups and immigrant rights organizations to join.
But things were fairly sluggish at AIDS Action Council, the largest Washington, DC AIDS lobby, which bills itself as the national voice on AIDS and represents more than 3,000 local service organizations. When Gay City News this Monday asked Ronald Johnson, AIDS Actions deputy executive director, for his organizations position on the new regs, he would only say, we are in the process of developing our comments and we are still looking at the fine print.
Johnson added, Well probably follow GMHCs analysis.
When this reporter suggested to Johnson that AIDS Action organize a national conference call with executive directors of AIDS advocacy organizations to mobilize them quickly against the harsh new regs, he said theyd think about it.
Fortunately, GMHC is already in the process of organizing such a conference call for next week, Ordover told Gay City News.
However, said Ordover, these regulations are in general a distraction what we really need to move forward on is getting the HIV-positive travel bar overturned completely.
In addition to her other duties at GHMC, Ordover is co-coordinator of Lift the Bar, a coalition of HIV, immigrant, human rights, and LGBT service and advocacy organizations working to overturn the HIV ban.
At a Congressional hearing last November, Ordover detailed the negative consequences of the travel ban.
The HIV bar rarely makes the news, and when we do hear about it, its usually because someone trying to attend some major event or forum being held in the US cant get into the country, Ordover said. This is not unimportant the International AIDS Conference hasnt been held on US soil for 16 years and the HIV bar is the reason. Despite our efforts in the global fight against HIV and AIDS, our standing in the international community has been grievously compromised by this policy.
Ordover, who noted that one-third of GMHCs clients are immigrants, also pointed out, Many people first learn they are HIV-positive after they get to the US. Many contract HIV here. Some find out their status when they get the results of their Immigration Service medical examination.
Under the current DHS regs in force, she said, Visitors either are actively deterred from seeking HIV testing and treatment, or avoid contact with providers out of fear of putting their immigration status in permanent limbo or worse. If they are low-income or poor, they either dont have recourse to the full slate of public programs and services they need to stay healthy or may be unaware of what services they are entitled to. At GMHC we view this policy as a violation of human rights and a threat to public health inside and outside the US. The proposed new regs do nothing to change this.
And, Ordover added, The truth is, the bar undermines public health and drives up the cost of health care. It forces HIV-positive immigrants to go underground, discourages immigrants who dont know their status from getting tested, from seeking preventive care, from seeking any care until they end up in the emergency room with full blown AIDS all things that undermine individual health, public health and that ultimately put more strain on the public coffers.
Individuals who wish to protest the harsh new DHS regs on HIV-positive travel may submit comments online at click - but to do so you must include the docket number of the proposed regs, USCBP-2007-0084. Organizations wishing to join in signing on to the statement GMHC is preparing in protest of the new regs should contact Nancy Ordover at nancyo@gmhc.org or 212-367-1240. Doug Ireland can be reached through his blog, DIRELAND, at click.
SOURCE: Gay City News
http://www.gaycitynews.com/site/news.cfm?newsid=19044628&BRD...
This is the proposed rule
http://federalregistersearch.com/2007/11/6/E7-21841.asp
Submitted comments should be mailed to:
Border Security Regulations Branch, Customs and Border Protection, 1300 Pennsylvania Avenue, NW. (Mint Annex), Washington, DC 20229.
Include this in your letter:
Reference:
[Federal Register: November 6, 2007 (Volume 72, Number 214)]
[Proposed Rules]
[Page 62593-62600]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no07-15]
DEPARTMENT OF HOMELAND SECURITY
Bureau of Customs and Border Protection
8 CFR Parts 100 and 212
[USCBP-2007-0084]
RIN 1651-AA71
"Issuance of a Visa and Authorization for Temporary Admission Into
the United States for Certain Nonimmigrant Aliens Infected With HIV"
Friday, November 23, 2007
Human Experimentation in Anabolic Steroid Research
worked with Dr Scally in the past and he is one of the country's experts on anabolic research. This is an e-book he just published.
America's Nuremberg - Human Experimentation in Anabolic Steroid Research by Michael Scally MD (eBook)
"America's Nuremberg - Human Experimentation in Anabolic Steroid Research" is a discussion of the ethical, medical, and legal violations for human subject protections in anabolic steroid research. Michael Scally, M.D. painstakingly chronicles current day human research abuses. The book describes how the ongoing public health and welfare is in danger due to government ignorance, pharmaceutical industry funding, and medical research community complicity. The money involved easily exceeds hundreds of millions of dollars. Those individuals affected number into the hundreds of thousands.
More Info:
http://www.mesomorphosis.com/store/anabolic-steroid-research-ebook.html
America's Nuremberg - Human Experimentation in Anabolic Steroid Research by Michael Scally MD (eBook)
"America's Nuremberg - Human Experimentation in Anabolic Steroid Research" is a discussion of the ethical, medical, and legal violations for human subject protections in anabolic steroid research. Michael Scally, M.D. painstakingly chronicles current day human research abuses. The book describes how the ongoing public health and welfare is in danger due to government ignorance, pharmaceutical industry funding, and medical research community complicity. The money involved easily exceeds hundreds of millions of dollars. Those individuals affected number into the hundreds of thousands.
More Info:
http://www.mesomorphosis.com/store/anabolic-steroid-research-ebook.html
Monday, October 15, 2007
Last HIV Update in Houston this year
WHEN: OCT 24, 6:30 PM
WHERE: UNITED WAY AT 50 WAUGH DRIVE
SPEAKER: NELSON VERGEL (POWERUSA.ORG)
LIMITED SEATING. E-mail HIVSeminars@aol.com or call the Houston Buyers Club at 713/520-5288
TOPICS:
1- Review of data on two new drugs in two new class recently approved- Selsentry- CCR5 inhibitor (http://www.selzentry.com/) and Isentress - integrase inhibitor(http://www.isentress.com )
2- Review of data on Etravirine (TMC 125), a non nuke now available via expanded access
3- Update on Metabolics and Lipodystrophy
4- Resources in Houston: programs to help people go back to work or school while keeping social security and Medicare/Medicaid, lipodystrophy study enrolling at Body Positive, and new clinics in Houston for the uninsured.
The New Wave of HIV Drugs Is Here
by Nelson Vergel
For the first time in 10 years, HIV-postive patients will have access to two new HIV drug classes. Patients with ongoing viral replication that have been failing current medicines will have a "second chance" to control their HIV by starting new drugs to which their virus has not mutated and become resistant. It is estimated that 20 percent of the half a million patients taking HIV medications in the United States are not responding to their medication and have ongoing viral replication in their bodies that may shorten their life spans and also make them more infectious to others.
No single HIV medication can control HIV by itself, needing at least two more in combination. But many people have HIV that has developed multidrug resistance (MDR) by mutating around medicines, which allows the virus to aggressively kill the CD4 cells that "direct" the immune system's response against invaders. MDR patients need to start at least two to three "active" drugs that their virus has never seen, but most have not had that luxury in the past few years due to drug approvals that did not happen concurrently.
Fortunately, two new drugs that work in completely new ways are making this possibility a reality for the first time since protease inhibitors were introduced to the market 10 years ago. A new entry inhibitor (Maraviroc, trade name: Selzentry) that works at attempting to block the attachment of HIV to the CD4 T cell, and the first integrase inhibitor (Raltegravir, trade name: Isentress) that works inside the nucleus of the CD4 cell, provide effective new targets to attack the virus. The most critical thing right now is to educate physicians and patients on how to best use these new drugs so that their benefits at lowering viral load to undetectable levels are sustained until a cure is found. Other medications like Fuzeon (an approved fusion inhibitor), Aptivus and Prezista (approved second generation protease inhibitors), and TMC 125 (a second generation non nucleoside analog in expanded access) can be combined with the two novel agents approved this year to hit the virus in different parts of its life cycle outside and inside the CD4 cell.
This second wave of HAART (highly active antiretroviral therapy) has the potential to save many lives. I urge patients not to screw up this last chance to get an effective combination before we go through another dry period of no new drugs in the coming few years. It is imperative to do your homework before jumping into a new regimen with limited data.
Nelson Vergel will be giving the last update for this year on recent conferences that had new data on these and other emerging options for HIV treatment. His lecture will be held on Oct. 24 at 6:30 pm at the United Way on 50 Waugh. Patients and clinicians are welcomed. Free parking and food will be provided. Seating is limited. For reservations or more information, e-mail HIVSeminars@aol.com or call the Houston Buyers Club at 713/520-5288. More information on new HIV medications can be found at Nelson's website www.SalvageTherapies.org.
WHERE: UNITED WAY AT 50 WAUGH DRIVE
SPEAKER: NELSON VERGEL (POWERUSA.ORG)
LIMITED SEATING. E-mail HIVSeminars@aol.com or call the Houston Buyers Club at 713/520-5288
TOPICS:
1- Review of data on two new drugs in two new class recently approved- Selsentry- CCR5 inhibitor (http://www.selzentry.com/) and Isentress - integrase inhibitor(http://www.isentress.com )
2- Review of data on Etravirine (TMC 125), a non nuke now available via expanded access
3- Update on Metabolics and Lipodystrophy
4- Resources in Houston: programs to help people go back to work or school while keeping social security and Medicare/Medicaid, lipodystrophy study enrolling at Body Positive, and new clinics in Houston for the uninsured.
The New Wave of HIV Drugs Is Here
by Nelson Vergel
For the first time in 10 years, HIV-postive patients will have access to two new HIV drug classes. Patients with ongoing viral replication that have been failing current medicines will have a "second chance" to control their HIV by starting new drugs to which their virus has not mutated and become resistant. It is estimated that 20 percent of the half a million patients taking HIV medications in the United States are not responding to their medication and have ongoing viral replication in their bodies that may shorten their life spans and also make them more infectious to others.
No single HIV medication can control HIV by itself, needing at least two more in combination. But many people have HIV that has developed multidrug resistance (MDR) by mutating around medicines, which allows the virus to aggressively kill the CD4 cells that "direct" the immune system's response against invaders. MDR patients need to start at least two to three "active" drugs that their virus has never seen, but most have not had that luxury in the past few years due to drug approvals that did not happen concurrently.
Fortunately, two new drugs that work in completely new ways are making this possibility a reality for the first time since protease inhibitors were introduced to the market 10 years ago. A new entry inhibitor (Maraviroc, trade name: Selzentry) that works at attempting to block the attachment of HIV to the CD4 T cell, and the first integrase inhibitor (Raltegravir, trade name: Isentress) that works inside the nucleus of the CD4 cell, provide effective new targets to attack the virus. The most critical thing right now is to educate physicians and patients on how to best use these new drugs so that their benefits at lowering viral load to undetectable levels are sustained until a cure is found. Other medications like Fuzeon (an approved fusion inhibitor), Aptivus and Prezista (approved second generation protease inhibitors), and TMC 125 (a second generation non nucleoside analog in expanded access) can be combined with the two novel agents approved this year to hit the virus in different parts of its life cycle outside and inside the CD4 cell.
This second wave of HAART (highly active antiretroviral therapy) has the potential to save many lives. I urge patients not to screw up this last chance to get an effective combination before we go through another dry period of no new drugs in the coming few years. It is imperative to do your homework before jumping into a new regimen with limited data.
Nelson Vergel will be giving the last update for this year on recent conferences that had new data on these and other emerging options for HIV treatment. His lecture will be held on Oct. 24 at 6:30 pm at the United Way on 50 Waugh. Patients and clinicians are welcomed. Free parking and food will be provided. Seating is limited. For reservations or more information, e-mail HIVSeminars@aol.com or call the Houston Buyers Club at 713/520-5288. More information on new HIV medications can be found at Nelson's website www.SalvageTherapies.org.
Friday, October 12, 2007
The best HIV drug in history approved today
Merck Gets FDA Approval
For New HIV Treatment
Wall St Jnl
By JENNIFER CORBETT DOOREN
October 12, 2007 5:50 p.m.
WASHINGTON -- A U.S. Food and Drug Administration panel Friday approved a new type of HIV drug from Merck & Co., a company spokeswoman said.
The drug, known by the brand name Isentress, was approved for use in patients who have failed treatment with other HIV drugs.
Isentress was approved as part of the FDA's accelerated-approval mechanism, which is aimed at getting life-saving treatments to market faster by allowing companies to submit less clinical data than usually required. Companies obtaining accelerated approval must keep studying drugs after they are on the market to gain full approval.
Isentress is designed to target one of three enzymes needed by HIV to reproduce. Current drugs on the market attack the other two enzymes, reverse transcriptase and protease. If approved, Isentress would be the only drug to target the third enzyme, known as integrase. Amy Rose, a Merck spokeswoman, said treatment with Isentress would cost about $9,850 a year.
Patients with HIV typically are treated with a "cocktail" of two or three types of drugs. However, over time, most HIV viruses mutate and stop responding to certain drugs, creating the need for new ones. Isentress is meant to be used in combination with other HIV drugs.
Merck's Isentress HIV Medicine Approved by U.S. FDA
By Shannon Pettypiece and Rob Waters
Oct. 12 (Bloomberg) -- Merck & Co.'s HIV drug Isentress was approved by U.S. regulators, offering a new option for the thousands of AIDS patients whose virus has developed resistance to other medicines.
Adding Isentress to drugs already on the market can slow the advance of HIV, the virus that causes AIDS, the Food and Drug Administration said today in a statement announcing the approval.
Isentress, Merck's first HIV therapy since 1999, may generate as much as $1 billion in annual sales worldwide, analysts said. About 150,000 Americans taking HIV medicines have a hard-to-treat form of the virus and may benefit from the new drug, said Robert Rode, Merck's vice president for infectious disease and hospital products.
``This is the first of a class of agents that should show growth for many years,'' said Robert Hazlett, an analyst with BMO Capital Markets in New York, in a telephone interview. ``We expect this drug to be widely considered in conjunction with other therapies for patients where existing therapies are failing.''
Hazlett said he expects sales of $400 million next year, rising to $950 million in 2010.
Merck rose 47 cents to $53.51 at 4 p.m. in New York Stock Exchange composite trading and have risen 23 percent this year.
Analysts had expected the FDA to approve Isentress after a panel of advisers recommended in August that the agency do so.
$27 a Day
Isentress, taken twice daily, will cost $27 a day, or almost $10,000 a year, similar to AIDS drugs developed in recent years, Merck spokeswoman Amy Rose said in a phone interview.
``We're pleased that the FDA recognizes the clinical profile of Isentress and the benefits it will bring to patients and physicians who are struggling to keep this disease under control,'' Rose said.
The new medicine uses a different method from other AIDS drugs to block the HIV virus from inserting its genetic material into human DNA, allowing replication. Isentress targets an enzyme called integrase that HIV uses to accomplish the task. Studies have shown the medicine helps patients with resistant strains of HIV when used in combination with other drugs.
Pfizer's Selzentry
This is the second new form of HIV medicine to come on the market this year. Pfizer Inc., the world's biggest drugmaker, won FDA approval in August for Selzentry, the first drug to block a chemical portal the HIV virus uses to enter cells.
Merck's studies found that Isentress reduced the virus to less than could be detected after four months in 61 to 62 percent of patients who got the medicine in combination with other anti- HIV drugs. That compares with 33 to 36 percent of those who got a placebo along with their most effective therapies.
Side effects included rashes, diarrhea, nausea and headaches. Although more patients taking Isentress developed cancers, the drug didn't appear to pose an increased risk, according to regulatory advisers.
Thirty AIDS treatments are approved in the U.S., according to the FDA. AIDS patients take so-called cocktails of anti-HIV drugs each day, typically three or more medicines. The drugs can't cure HIV, and people with the infections still have the virus in their bodies. Eventually, HIV develops resistance to treatment. Once a drug fails, the combination loses effectiveness.
Further Studies
Merck is also studying the drug in children and patients who haven't been on any other HIV medicines.
All HIV drugs are designed to interfere with a part of the HIV life cycle of infection and replication. HIV attacks and destroys white blood cells, which the immune system uses to fend off invasions from viruses and bacteria.
GlaxoSmithKline Plc's Lexiva and Pfizer's Viracept interfere with the action of the protease enzyme, while drugs such as Gilead Sciences Inc.'s Viread inactivate another viral enzyme, reverse transcriptase.
A third class of medications, called entry inhibitors, works by blocking HIV from entering target white cells. These drugs include Roche Holding AG and Trimeris Inc.'s Fuzeon, which reached the market in 2003.
Merck sold the U.S. rights to its previous AIDS drug, Stocrin, to Bristol-Myers Squibb Co., which markets it under the name Sustiva. Merck continues to market Stocrin outside the U.S. and sells another older AIDS drug, Crixivan.
For New HIV Treatment
Wall St Jnl
By JENNIFER CORBETT DOOREN
October 12, 2007 5:50 p.m.
WASHINGTON -- A U.S. Food and Drug Administration panel Friday approved a new type of HIV drug from Merck & Co., a company spokeswoman said.
The drug, known by the brand name Isentress, was approved for use in patients who have failed treatment with other HIV drugs.
Isentress was approved as part of the FDA's accelerated-approval mechanism, which is aimed at getting life-saving treatments to market faster by allowing companies to submit less clinical data than usually required. Companies obtaining accelerated approval must keep studying drugs after they are on the market to gain full approval.
Isentress is designed to target one of three enzymes needed by HIV to reproduce. Current drugs on the market attack the other two enzymes, reverse transcriptase and protease. If approved, Isentress would be the only drug to target the third enzyme, known as integrase. Amy Rose, a Merck spokeswoman, said treatment with Isentress would cost about $9,850 a year.
Patients with HIV typically are treated with a "cocktail" of two or three types of drugs. However, over time, most HIV viruses mutate and stop responding to certain drugs, creating the need for new ones. Isentress is meant to be used in combination with other HIV drugs.
Merck's Isentress HIV Medicine Approved by U.S. FDA
By Shannon Pettypiece and Rob Waters
Oct. 12 (Bloomberg) -- Merck & Co.'s HIV drug Isentress was approved by U.S. regulators, offering a new option for the thousands of AIDS patients whose virus has developed resistance to other medicines.
Adding Isentress to drugs already on the market can slow the advance of HIV, the virus that causes AIDS, the Food and Drug Administration said today in a statement announcing the approval.
Isentress, Merck's first HIV therapy since 1999, may generate as much as $1 billion in annual sales worldwide, analysts said. About 150,000 Americans taking HIV medicines have a hard-to-treat form of the virus and may benefit from the new drug, said Robert Rode, Merck's vice president for infectious disease and hospital products.
``This is the first of a class of agents that should show growth for many years,'' said Robert Hazlett, an analyst with BMO Capital Markets in New York, in a telephone interview. ``We expect this drug to be widely considered in conjunction with other therapies for patients where existing therapies are failing.''
Hazlett said he expects sales of $400 million next year, rising to $950 million in 2010.
Merck rose 47 cents to $53.51 at 4 p.m. in New York Stock Exchange composite trading and have risen 23 percent this year.
Analysts had expected the FDA to approve Isentress after a panel of advisers recommended in August that the agency do so.
$27 a Day
Isentress, taken twice daily, will cost $27 a day, or almost $10,000 a year, similar to AIDS drugs developed in recent years, Merck spokeswoman Amy Rose said in a phone interview.
``We're pleased that the FDA recognizes the clinical profile of Isentress and the benefits it will bring to patients and physicians who are struggling to keep this disease under control,'' Rose said.
The new medicine uses a different method from other AIDS drugs to block the HIV virus from inserting its genetic material into human DNA, allowing replication. Isentress targets an enzyme called integrase that HIV uses to accomplish the task. Studies have shown the medicine helps patients with resistant strains of HIV when used in combination with other drugs.
Pfizer's Selzentry
This is the second new form of HIV medicine to come on the market this year. Pfizer Inc., the world's biggest drugmaker, won FDA approval in August for Selzentry, the first drug to block a chemical portal the HIV virus uses to enter cells.
Merck's studies found that Isentress reduced the virus to less than could be detected after four months in 61 to 62 percent of patients who got the medicine in combination with other anti- HIV drugs. That compares with 33 to 36 percent of those who got a placebo along with their most effective therapies.
Side effects included rashes, diarrhea, nausea and headaches. Although more patients taking Isentress developed cancers, the drug didn't appear to pose an increased risk, according to regulatory advisers.
Thirty AIDS treatments are approved in the U.S., according to the FDA. AIDS patients take so-called cocktails of anti-HIV drugs each day, typically three or more medicines. The drugs can't cure HIV, and people with the infections still have the virus in their bodies. Eventually, HIV develops resistance to treatment. Once a drug fails, the combination loses effectiveness.
Further Studies
Merck is also studying the drug in children and patients who haven't been on any other HIV medicines.
All HIV drugs are designed to interfere with a part of the HIV life cycle of infection and replication. HIV attacks and destroys white blood cells, which the immune system uses to fend off invasions from viruses and bacteria.
GlaxoSmithKline Plc's Lexiva and Pfizer's Viracept interfere with the action of the protease enzyme, while drugs such as Gilead Sciences Inc.'s Viread inactivate another viral enzyme, reverse transcriptase.
A third class of medications, called entry inhibitors, works by blocking HIV from entering target white cells. These drugs include Roche Holding AG and Trimeris Inc.'s Fuzeon, which reached the market in 2003.
Merck sold the U.S. rights to its previous AIDS drug, Stocrin, to Bristol-Myers Squibb Co., which markets it under the name Sustiva. Merck continues to market Stocrin outside the U.S. and sells another older AIDS drug, Crixivan.
Merck's New AIDS Drug Has Promise -- if It Isn't Too Pricey
Merck's New AIDS Drug Has Promise -- if It Isn't Too Pricey
Wall St Journal
By SARAH RUBENSTEIN
October 11, 2007; Page B1
Merck & Co. could break new ground on the AIDS-fighting front this week with the Food and Drug Administration's expected approval of Isentress, a new type of drug that could be especially useful for patients who no longer respond to many existing treatments. Yet despite the continuing need and market for HIV treatments, and doctors' enthusiasm about the drug's prospects, it's no sure thing that Isentress will pay off for Merck.
A major factor is pricing, yet to be determined and especially important because of the recent arrival of several other drugs to fight HIV, the virus that causes AIDS. Pfizer Inc.'s Selzentry, which won regulatory approval this summer, costs about $10,600 a year wholesale. Roche Holding AG's Fuzeon, which came out in 2003, costs about $24,500 a year wholesale, much higher than many other AIDS drugs. And Johnson & Johnson came out with Prezista last year and may win approval of another HIV drug in early 2008.
Merck declines to discuss pricing ahead of an FDA decision. But if the company were to price Isentress at the high end of the range, "there's no way the system could handle that," says Lanny Cross, a former director of the New York AIDS Drug Assistance Program and a consultant for the National Alliance of State and Territorial AIDS Directors.
Martin Delaney, a longtime AIDS activist, who has participated in price negotiations with Merck on behalf of a group called the Fair Pricing Coalition, says the company has shown sensitivity to patients' financial needs in the past. But he says Merck officials have been "arguing they need to get profitability." He says Merck has indicated it wants to price Isentress in the range of relatively new AIDS drugs such as Prezista and Bristol-Myers Squibb Co.'s Reyataz, both of which cost around $9,500 a year wholesale, according to their makers. He also says Merck has told him it has spent close to $2 billion on HIV research.
Isentress arrives at a time when Merck has just one other HIV drug in clinical trials, at the earliest stage of such testing. And it is just weeks after Merck's leading experimental AIDS vaccine collapsed in a clinical trial. Isentress represents a chance for Merck to show it is still a major player in this arena despite a years-long gap since it last brought a new drug to counter HIV to the market. Some doctors are excited by Isentress's potential, in particular because the pill represents a new way to attack a virus that has managed to develop resistance to many other drugs.
An advisory panel of outside medical experts last month said the data support FDA approval of Isentress for patients who have failed treatment with other HIV drugs. The agency isn't required to follow such panels' advice, but usually does.
Merck may find it difficult to sell Isentress at the highest price possible when many public-assistance programs that help pay for HIV treatments are experiencing fiscal strain. In the 2006 fiscal year, 20 out of nearly 60 AIDS Drug Assistance Programs saw their budgets decrease, according to the Kaiser Family Foundation, a nonprofit health-policy research group in Menlo Park, Calif. Such programs bought drugs for nearly 100,000 HIV patients in 2006 and provided insurance coverage for thousands more, according to Kaiser.
Merck declines to specify how much it spent to develop Isentress or to research other HIV drugs, beyond saying it has spent "hundreds of millions of dollars" on such work. "We believe [HIV research] is the right thing to do," says Robin Isaacs, the Whitehouse Station, N.J., company's executive director of infectious-disease clinical research. "We are hopeful that will translate into return on investment for our shareholders."
While Merck is viewed by many in the AIDS community as one of the major drug makers most committed to HIV research, revenue from such products currently represents a modicum of Merck's total revenue, which amounted to $22.64 billion last year. The company drew a combined $327 million from sales of Crixivan, an HIV drug from the mid-1990s that is no longer used widely, and Stocrin, which Merck sells overseas.
Isentress could provide a bottom-line boost, though it doesn't carry the potential of some major Merck products such as asthma-drug Singulair, which had $3.58 billion of sales last year. Credit Suisse drug analyst Catherine Arnold estimates Merck's annual sales of Isentress could be $500 million world-wide by 2012, and likely more if used in a broad swath of patients. Merck is an investment-banking client of Credit Suisse.
Another factor influencing Isentress's prospects is whether doctors will prescribe it for patients in early stages of HIV treatment. The FDA advisory panel debated how early in a patient's treatment to approve Isentress use, given that most patients in Merck's trials had used a number of drugs already. It will be up to the FDA to make that determination -- though doctors would be permitted to prescribe Isentress "off label" at any point in treatment.
About two-dozen HIV drugs are now available, most of which block two enzymes that HIV uses to replicate in the body: protease and reverse transcriptase. Isentress, known generically as raltegravir, would be the first drug on the market to target a third enzyme -- integrase -- that helps the virus insert its DNA into that of human cells.
Because HIV mutates quickly to outwit drugs, cocktails of three medications are typically used to simultaneously attack the virus in different spots. Patients tend to change drugs as their virus adapts. Isentress would be taken along with other drugs.
Merck's late-stage studies of Isentress involved patients who had been receiving HIV treatment for a median of 10 years, had virus resistant to at least one drug in each of three major classes of HIV drugs and showed evidence the virus was continuing to replicate in their bodies. In other words, they were already sick or in danger of becoming sick soon.
"Since this drug seems to be very effective and pretty well tolerated, I think [there is] potential for it to move in and take territory" from some older drugs, says Judith Feinberg, a leader of the AIDS clinical-trials unit at the University of Cincinnati College of Medicine who served on the advisory panel.
However, she said some doctors may be uncomfortable prescribing Isentress more broadly until further studies are complete. Merck is currently conducting late-stage Isentress studies in patients who are new to HIV treatment. The company expects to have the results toward the end of 2008. Dr. Feinberg says she had no ties to Merck at the time of the panel hearing but has since agreed to give talks sponsored by the company.
Isentress will be used principally in "patients who have tried a whole raft of drugs," says Daniel Kuritzkes, director of AIDS research at Brigham and Women's Hospital in Boston, who consults for Merck and other HIV-drug makers. However, "for patients who have earlier stages of disease, there will be some tendency to hold off because it's so useful in patients with extensive treatment experience."
Another potential complication is that Isentress is taken twice a day, while some new patients take a once-a-day pill called Atripla that combines three drugs. That could make it tougher to get patients to take Isentress from the beginning.
While Merck has little else for HIV in clinical trials, research-and-development chief Peter Kim says the company is committed to pursuing HIV treatments, and continues to do research related to the integrase enzyme.
"We really do think that this drug-resistance issue is going to continue to be a significant unmet medical need," Dr. Kim says.
Wall St Journal
By SARAH RUBENSTEIN
October 11, 2007; Page B1
Merck & Co. could break new ground on the AIDS-fighting front this week with the Food and Drug Administration's expected approval of Isentress, a new type of drug that could be especially useful for patients who no longer respond to many existing treatments. Yet despite the continuing need and market for HIV treatments, and doctors' enthusiasm about the drug's prospects, it's no sure thing that Isentress will pay off for Merck.
A major factor is pricing, yet to be determined and especially important because of the recent arrival of several other drugs to fight HIV, the virus that causes AIDS. Pfizer Inc.'s Selzentry, which won regulatory approval this summer, costs about $10,600 a year wholesale. Roche Holding AG's Fuzeon, which came out in 2003, costs about $24,500 a year wholesale, much higher than many other AIDS drugs. And Johnson & Johnson came out with Prezista last year and may win approval of another HIV drug in early 2008.
Merck declines to discuss pricing ahead of an FDA decision. But if the company were to price Isentress at the high end of the range, "there's no way the system could handle that," says Lanny Cross, a former director of the New York AIDS Drug Assistance Program and a consultant for the National Alliance of State and Territorial AIDS Directors.
Martin Delaney, a longtime AIDS activist, who has participated in price negotiations with Merck on behalf of a group called the Fair Pricing Coalition, says the company has shown sensitivity to patients' financial needs in the past. But he says Merck officials have been "arguing they need to get profitability." He says Merck has indicated it wants to price Isentress in the range of relatively new AIDS drugs such as Prezista and Bristol-Myers Squibb Co.'s Reyataz, both of which cost around $9,500 a year wholesale, according to their makers. He also says Merck has told him it has spent close to $2 billion on HIV research.
Isentress arrives at a time when Merck has just one other HIV drug in clinical trials, at the earliest stage of such testing. And it is just weeks after Merck's leading experimental AIDS vaccine collapsed in a clinical trial. Isentress represents a chance for Merck to show it is still a major player in this arena despite a years-long gap since it last brought a new drug to counter HIV to the market. Some doctors are excited by Isentress's potential, in particular because the pill represents a new way to attack a virus that has managed to develop resistance to many other drugs.
An advisory panel of outside medical experts last month said the data support FDA approval of Isentress for patients who have failed treatment with other HIV drugs. The agency isn't required to follow such panels' advice, but usually does.
Merck may find it difficult to sell Isentress at the highest price possible when many public-assistance programs that help pay for HIV treatments are experiencing fiscal strain. In the 2006 fiscal year, 20 out of nearly 60 AIDS Drug Assistance Programs saw their budgets decrease, according to the Kaiser Family Foundation, a nonprofit health-policy research group in Menlo Park, Calif. Such programs bought drugs for nearly 100,000 HIV patients in 2006 and provided insurance coverage for thousands more, according to Kaiser.
Merck declines to specify how much it spent to develop Isentress or to research other HIV drugs, beyond saying it has spent "hundreds of millions of dollars" on such work. "We believe [HIV research] is the right thing to do," says Robin Isaacs, the Whitehouse Station, N.J., company's executive director of infectious-disease clinical research. "We are hopeful that will translate into return on investment for our shareholders."
While Merck is viewed by many in the AIDS community as one of the major drug makers most committed to HIV research, revenue from such products currently represents a modicum of Merck's total revenue, which amounted to $22.64 billion last year. The company drew a combined $327 million from sales of Crixivan, an HIV drug from the mid-1990s that is no longer used widely, and Stocrin, which Merck sells overseas.
Isentress could provide a bottom-line boost, though it doesn't carry the potential of some major Merck products such as asthma-drug Singulair, which had $3.58 billion of sales last year. Credit Suisse drug analyst Catherine Arnold estimates Merck's annual sales of Isentress could be $500 million world-wide by 2012, and likely more if used in a broad swath of patients. Merck is an investment-banking client of Credit Suisse.
Another factor influencing Isentress's prospects is whether doctors will prescribe it for patients in early stages of HIV treatment. The FDA advisory panel debated how early in a patient's treatment to approve Isentress use, given that most patients in Merck's trials had used a number of drugs already. It will be up to the FDA to make that determination -- though doctors would be permitted to prescribe Isentress "off label" at any point in treatment.
About two-dozen HIV drugs are now available, most of which block two enzymes that HIV uses to replicate in the body: protease and reverse transcriptase. Isentress, known generically as raltegravir, would be the first drug on the market to target a third enzyme -- integrase -- that helps the virus insert its DNA into that of human cells.
Because HIV mutates quickly to outwit drugs, cocktails of three medications are typically used to simultaneously attack the virus in different spots. Patients tend to change drugs as their virus adapts. Isentress would be taken along with other drugs.
Merck's late-stage studies of Isentress involved patients who had been receiving HIV treatment for a median of 10 years, had virus resistant to at least one drug in each of three major classes of HIV drugs and showed evidence the virus was continuing to replicate in their bodies. In other words, they were already sick or in danger of becoming sick soon.
"Since this drug seems to be very effective and pretty well tolerated, I think [there is] potential for it to move in and take territory" from some older drugs, says Judith Feinberg, a leader of the AIDS clinical-trials unit at the University of Cincinnati College of Medicine who served on the advisory panel.
However, she said some doctors may be uncomfortable prescribing Isentress more broadly until further studies are complete. Merck is currently conducting late-stage Isentress studies in patients who are new to HIV treatment. The company expects to have the results toward the end of 2008. Dr. Feinberg says she had no ties to Merck at the time of the panel hearing but has since agreed to give talks sponsored by the company.
Isentress will be used principally in "patients who have tried a whole raft of drugs," says Daniel Kuritzkes, director of AIDS research at Brigham and Women's Hospital in Boston, who consults for Merck and other HIV-drug makers. However, "for patients who have earlier stages of disease, there will be some tendency to hold off because it's so useful in patients with extensive treatment experience."
Another potential complication is that Isentress is taken twice a day, while some new patients take a once-a-day pill called Atripla that combines three drugs. That could make it tougher to get patients to take Isentress from the beginning.
While Merck has little else for HIV in clinical trials, research-and-development chief Peter Kim says the company is committed to pursuing HIV treatments, and continues to do research related to the integrase enzyme.
"We really do think that this drug-resistance issue is going to continue to be a significant unmet medical need," Dr. Kim says.
Thursday, October 11, 2007
Lipodystrophy Providers List
Still slow response (60 responders in a list of 2500 people in pozhealth at yahoogroups.com), but we are starting to see some valuable information
Click on "view" in questions 2, 3 and 4 to see what people have typed in
http://www.surveymonkey.com/sr.aspx?sm=rc8hHUnWoT5VVui7aS9Q_2fsfxahbyw7goBCGlfANmm4A_3d
For those of you who want to share with us, use this link
http://www.surveymonkey.com/s.aspx?sm=dIXsY8YIuuh5f_2fMLZasLgA_3d_3d
Click on "view" in questions 2, 3 and 4 to see what people have typed in
http://www.surveymonkey.com/sr.aspx?sm=rc8hHUnWoT5VVui7aS9Q_2fsfxahbyw7goBCGlfANmm4A_3d
For those of you who want to share with us, use this link
http://www.surveymonkey.com/s.aspx?sm=dIXsY8YIuuh5f_2fMLZasLgA_3d_3d
Wednesday, October 10, 2007
Letter to Doctors and ADAP directors about changes in weight loss/quality of life medication access
May 8, 2007
Dear ADAP Director:
As you may be aware, your HIV patients will soon face an abrupt change in available treatment options for HIV-related weight loss and AIDS wasting syndrome. In March 2007, Watson Laboratories, the sole manufacturer of the inexpensive HIV anti-wasting agent nandrolone decanoate (also known as Deca-Durabolin), halted production of this agent. Instead, Watson will promote their generic version of Oxandrin (oxandrolone). As patient advocates, we are alarmed that patients now will have to switch to an agent that is over five times the cost, with a greater risk of hepatotoxicity.
Watson had a previous licensing agreement with Savient Pharmaceuticals, the maker of Oxandrin brand oxandrolone. In December 2006, Watson received the go-ahead from Savient to begin marketing oxandrolone as an AB generic.
After acquiring rights to sell generic oxandrolone, in March 2007 Watson stopped production of nandrolone. This left oxandrolone as the only other anabolic steroid treatment on the market that has been studied in trials for AIDS wasting.
BTG Pharmaceuticals, later bought out by Savient Pharmaceuticals, set up a patient assistance program (PAP) for Oxandrin when it was launched in the mid 90’s. But in April, Savient announced the end of the old patient assistance plan. Patients who are most in need and have the fewest resources are plain out of luck.
The projected cost of the generic Oxandrin will be virtually the same as the ‘brand name’ version, with less than a 15% price difference at the time of this letter. A key HIV pharmacy in Los Angeles will be charging $1350.00 for a typical month's worth (20 mg /day) of branded Oxandrin from Savient, versus $1100.00 for the AB generic from Watson. (This compares with a cost of about $200 per month for 200 mg a week of nandrolone.)
Out of the fifty states, only nine AIDS Drug Assistance Program (ADAP) formularies (Alaska, Arizona, California, Delaware, Florida, Maryland, New Hampshire, and New Jersey) cover Oxandrin and nandrolone, six (Connecticut, DC, Kansas, Michigan, Mississipi, and Oklahoma) cover Oxandrin only, and four (Georgia, Indiana, Nevada, and New York) cover nandrolone only; patients in the remaining states either pay for it out-of-pocket, or obtained it through the now-defunct patient assistance program. Private insurers often do not cover Oxandrin without time-consuming prior authorizations, which will leave your HIV wasting patients without medication for weeks if not months. These burdensome prior authorizations must be repeated every three months.
One stop-gap solution for your patients is to avail themselves of nandrolone composed at compounding pharmacies, whose prices are usually even less than Watson's version of nandrolone. However, these pharmacies do not process insurance claims or are equipped to supply ADAPs, Medicaids and Medicare Part D vendors. (A list of compounding pharmacies is attached to this letter.)
Still, use of compounding pharmacies is a stop-gap solution. Your patients and third party payment systems need a more permanent solution. It is imperative that Watson hear from credible health care providers such as yourself that their actions have adversely affected your patients' treatment options, and that Watson should resume nandrolone manufacturing. It would also be important to let Savient hear about how their decision of stopping Oxandrin’s PAP would negatively affect your patients. Watson's fax number is 951-493-5842 and corporate office is 951-493-5300. Savient’s telephone is 732-418-9300 and fax 732-418-0570
We have enclosed copies of two articles on this subject, a list of compounding pharmacies that supply nandrolone, oxandrolone and testosterone gels, and our non-profit resource post cards. For more information on this matter and future updates, please visit http://savehivwastingmeds.blogspot.com/ or our main portal www.powerusa.org. If you wish to help us with this patient advocacy issue, there are sample letters in that blog that could be sent to Watson and Savient from your office.
Fortunately, the incidence of involuntary weight loss has decreased in the post-HAART era but there still is a small number of patients that may need help after an opportunistic infection or other illness. According to a study at Tufts University, 29% of people with undetectable viremia still experience involuntary weight loss and have low body mass index. According to over 9 studies performed in men and women with HIV, physician-monitored use of anabolic agents has been shown to help those patients regain body mass and stamina.
Please do not hesitate to let us know if you need any more information and if you can help us to inform the patient community about their treatment options for involuntary weight loss.
Sincerely,
Nelson Vergel
Director
Applied Pharmacy Services 3207 International Drive
Mobile, AL 36606 877-729-1015 877-729-1019 www.appliedpharmacyrx.com info@appliedpharmacyrx.com $9.50 per ml in a 10 ml multi dose vial or $9.75 per ml for a 4 ml multi dose vial or $10.00 per ml in a 1 ml vial
The Compounding Shop 4000 Park St. N St Petersburg Florida 33709 866-792-6731 727-347-2056 www.gotocompoundingshop.com info@gotocompoundingshop.com $12.00 per ml in 10 ml multi dose vial
Collage Pharmacy 3505 Austin Bluffs Parkway, Suite 101
Colorado Springs, CO 80918
800-888-9358 (800) 556-5893 or (719) 262-0035 http://collegepharmacy.com info@collegepharmacy.com only available as a 10 ml multi dose vial for $94.75 this is for 200 mg/ml, this compounder also offers100 mg/ml
Kronos Compounding Pharmacy Now sold to AnazaoHealth 3675 S. Rainbow Blvd.
Suite #103
Las Vegas, NV 89103-1059 800-723-7455 800-238-8239 www.anazaohealth.com info@anziohealth.com $26.50 per ml for a 10 ML vial
Medaus Pharmacy 2637 Valleydale Road
Birmingham, Alabama 35244 800-526-9184
800-526-9184
http://www.medaus.com\ info@medaus.com $44.00 per ml in one ml vials or or 18.60 per ml in 10 ml multi dose vials
B&B Pharmacy 10244 Rosecrans Ave BellFlower, CA 90706 562-866-8363 http://www.bbpharmacy.com/index.html info@BBPharmacy.com Unavailable at this time,
Dear ADAP Director:
As you may be aware, your HIV patients will soon face an abrupt change in available treatment options for HIV-related weight loss and AIDS wasting syndrome. In March 2007, Watson Laboratories, the sole manufacturer of the inexpensive HIV anti-wasting agent nandrolone decanoate (also known as Deca-Durabolin), halted production of this agent. Instead, Watson will promote their generic version of Oxandrin (oxandrolone). As patient advocates, we are alarmed that patients now will have to switch to an agent that is over five times the cost, with a greater risk of hepatotoxicity.
Watson had a previous licensing agreement with Savient Pharmaceuticals, the maker of Oxandrin brand oxandrolone. In December 2006, Watson received the go-ahead from Savient to begin marketing oxandrolone as an AB generic.
After acquiring rights to sell generic oxandrolone, in March 2007 Watson stopped production of nandrolone. This left oxandrolone as the only other anabolic steroid treatment on the market that has been studied in trials for AIDS wasting.
BTG Pharmaceuticals, later bought out by Savient Pharmaceuticals, set up a patient assistance program (PAP) for Oxandrin when it was launched in the mid 90’s. But in April, Savient announced the end of the old patient assistance plan. Patients who are most in need and have the fewest resources are plain out of luck.
The projected cost of the generic Oxandrin will be virtually the same as the ‘brand name’ version, with less than a 15% price difference at the time of this letter. A key HIV pharmacy in Los Angeles will be charging $1350.00 for a typical month's worth (20 mg /day) of branded Oxandrin from Savient, versus $1100.00 for the AB generic from Watson. (This compares with a cost of about $200 per month for 200 mg a week of nandrolone.)
Out of the fifty states, only nine AIDS Drug Assistance Program (ADAP) formularies (Alaska, Arizona, California, Delaware, Florida, Maryland, New Hampshire, and New Jersey) cover Oxandrin and nandrolone, six (Connecticut, DC, Kansas, Michigan, Mississipi, and Oklahoma) cover Oxandrin only, and four (Georgia, Indiana, Nevada, and New York) cover nandrolone only; patients in the remaining states either pay for it out-of-pocket, or obtained it through the now-defunct patient assistance program. Private insurers often do not cover Oxandrin without time-consuming prior authorizations, which will leave your HIV wasting patients without medication for weeks if not months. These burdensome prior authorizations must be repeated every three months.
One stop-gap solution for your patients is to avail themselves of nandrolone composed at compounding pharmacies, whose prices are usually even less than Watson's version of nandrolone. However, these pharmacies do not process insurance claims or are equipped to supply ADAPs, Medicaids and Medicare Part D vendors. (A list of compounding pharmacies is attached to this letter.)
Still, use of compounding pharmacies is a stop-gap solution. Your patients and third party payment systems need a more permanent solution. It is imperative that Watson hear from credible health care providers such as yourself that their actions have adversely affected your patients' treatment options, and that Watson should resume nandrolone manufacturing. It would also be important to let Savient hear about how their decision of stopping Oxandrin’s PAP would negatively affect your patients. Watson's fax number is 951-493-5842 and corporate office is 951-493-5300. Savient’s telephone is 732-418-9300 and fax 732-418-0570
We have enclosed copies of two articles on this subject, a list of compounding pharmacies that supply nandrolone, oxandrolone and testosterone gels, and our non-profit resource post cards. For more information on this matter and future updates, please visit http://savehivwastingmeds.blogspot.com/ or our main portal www.powerusa.org. If you wish to help us with this patient advocacy issue, there are sample letters in that blog that could be sent to Watson and Savient from your office.
Fortunately, the incidence of involuntary weight loss has decreased in the post-HAART era but there still is a small number of patients that may need help after an opportunistic infection or other illness. According to a study at Tufts University, 29% of people with undetectable viremia still experience involuntary weight loss and have low body mass index. According to over 9 studies performed in men and women with HIV, physician-monitored use of anabolic agents has been shown to help those patients regain body mass and stamina.
Please do not hesitate to let us know if you need any more information and if you can help us to inform the patient community about their treatment options for involuntary weight loss.
Sincerely,
Nelson Vergel
Director
Applied Pharmacy Services 3207 International Drive
Mobile, AL 36606 877-729-1015 877-729-1019 www.appliedpharmacyrx.com info@appliedpharmacyrx.com $9.50 per ml in a 10 ml multi dose vial or $9.75 per ml for a 4 ml multi dose vial or $10.00 per ml in a 1 ml vial
The Compounding Shop 4000 Park St. N St Petersburg Florida 33709 866-792-6731 727-347-2056 www.gotocompoundingshop.com info@gotocompoundingshop.com $12.00 per ml in 10 ml multi dose vial
Collage Pharmacy 3505 Austin Bluffs Parkway, Suite 101
Colorado Springs, CO 80918
800-888-9358 (800) 556-5893 or (719) 262-0035 http://collegepharmacy.com info@collegepharmacy.com only available as a 10 ml multi dose vial for $94.75 this is for 200 mg/ml, this compounder also offers100 mg/ml
Kronos Compounding Pharmacy Now sold to AnazaoHealth 3675 S. Rainbow Blvd.
Suite #103
Las Vegas, NV 89103-1059 800-723-7455 800-238-8239 www.anazaohealth.com info@anziohealth.com $26.50 per ml for a 10 ML vial
Medaus Pharmacy 2637 Valleydale Road
Birmingham, Alabama 35244 800-526-9184
800-526-9184
http://www.medaus.com\ info@medaus.com $44.00 per ml in one ml vials or or 18.60 per ml in 10 ml multi dose vials
B&B Pharmacy 10244 Rosecrans Ave BellFlower, CA 90706 562-866-8363 http://www.bbpharmacy.com/index.html info@BBPharmacy.com Unavailable at this time,
Cheap HIV drugs are more important than patents
Tuesday, October 09, 2007
African countries should follow Thailand's lead in manufacturing their own affordable medication in the face of U.S. pressure.
By Lara Santoro
October 9, 2007 In January, the Thai government gave its domestic drug manufacturers carte blanche to effectively copy the formula for Abbot Laboratories' AIDS drug, Kaletra, and reproduce it in Thailand at a fraction of the cost.
A storm of protest ensued. The U.S. placed Thailand on a "priority watch list" of badly behaved countries. The European Union followed suit with a sharply worded letter from Trade Commissioner Peter Mandelson lamenting Thailand's outrageous disregard for Abbot's intellectual property.
Yet, contrary to common perception, Thailand's move was, and remains, in perfect observance of international law. The Doha Agreement on Trade-related Aspects of Intellectual Property Rights, signed by all members of the World Trade Organization, stipulates that "every country has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted."
"Compulsory" licenses essentially allow governments to revoke patents when they are deemed to work against the public good, either by stifling competition or unreasonably restricting access to a product. Once a royalty fee is negotiated and a time limit set, governments are free to compel the original patent holder to hand over its intellectual property.
The U.S. government routinely grants compulsory licenses for purely commercial reasons, largely to streamline production of consumer electronics and military hardware. Five such licenses were issued in the last year alone, one of them specifically to Abbott. To no one's horror or, frankly, interest, Italy recently issued a compulsory license for a drug that treats enlarged prostates.
Thailand's compulsory license addresses a far starker reality -- in a country of 65 million, 650,000 people (one in every 100) is infected by the AIDS virus. With soaring temperatures -- and refrigeration the exception rather than the rule -- heat-stable drugs such as Kaletra are crucial. Kaletra also has the advantage of low toxicity; for people whose livers have withstood years of harsh antiretroviral treatment, Kaletra is a gentler, but prohibitively priced, passport to life.
Why, then, has the Thai government's attempt to acquire a lifesaving drug run into a wall of corporate indignation and government censure?
The standard answer is that pharmaceutical advances are based on the respect of intellectual property. Without the protective role of patents, the argument goes, drug makers would fail to recover their research-and-development costs and consequently shy away from pursuing new drugs.
The truth is that more than half of all antiretroviral drugs were researched entirely on U.S. government grants. Both lopinavir and ritonavir, the two antiretroviral agents in Kaletra, were researched with public money. "Heck, we paid for them," said James Love, director of the Washington-based Consumer Project on Technology.
The pharmaceutical industry lives in fear of a cheap-drug domino effect. Thailand's compulsory license could inspire the entire continent of Africa -- where 70% of the world's 40 million HIV/AIDS cases are found -- to issue licenses for a series of drugs.
Countries such as Kenya and Uganda, not to mention South Africa, have not only the manufacturing base needed to copy and reproduce drugs for a fraction of their cost, they also have the right. So what's stopping them? "There is a history of trade pressures," Love said. "Very few countries are willing to face such pressures."
Despite death on an unimaginable scale, talk of compulsory licensing remains anathema in most of Africa, so millions of lives are left in the hands of a well-meaning yet ineffectual group of international donors, whose solution to the problem has been to purchase and distribute generic AIDS drugs made in India and Brazil. It's a noble effort, but with pitiful results. Fifteen years after the invention of antiretrovirals, only one in four Africans has access to them.
But it gets worse. For many of those who survived thanks to first-line treatments, the time has come to switch to newer, less-toxic drugs -- all of them patented, none of them even remotely available. "We're starting from zero again," said Buddhima Lokuge, U.S. manager of Doctors Without Borders' "campaign for access to essential medicines." By the time generic competition kicks in for the newer drugs, millions of people will have died unnecessarily.
The AIDS epidemic will constitute the single greatest loss of life in modern history. It is impossible for us in the West to conceive of death on such a scale. Far more difficult to understand, however, is the arbitrary nature of this holocaust: The drugs exist, why can't people have them?
African countries should find the resolve to follow Thailand's example and grant compulsory licenses when they see fit. In so doing, they would put an end to a drug monopoly whose human cost brings shame to us all.
Lara Santoro worked as a journalist in Africa from 1997 to 2004.
SOURCE: Los Angeles Times
http://www.latimes.com/news/opinion/la-oe-santoro9oct09,0,43...
African countries should follow Thailand's lead in manufacturing their own affordable medication in the face of U.S. pressure.
By Lara Santoro
October 9, 2007 In January, the Thai government gave its domestic drug manufacturers carte blanche to effectively copy the formula for Abbot Laboratories' AIDS drug, Kaletra, and reproduce it in Thailand at a fraction of the cost.
A storm of protest ensued. The U.S. placed Thailand on a "priority watch list" of badly behaved countries. The European Union followed suit with a sharply worded letter from Trade Commissioner Peter Mandelson lamenting Thailand's outrageous disregard for Abbot's intellectual property.
Yet, contrary to common perception, Thailand's move was, and remains, in perfect observance of international law. The Doha Agreement on Trade-related Aspects of Intellectual Property Rights, signed by all members of the World Trade Organization, stipulates that "every country has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted."
"Compulsory" licenses essentially allow governments to revoke patents when they are deemed to work against the public good, either by stifling competition or unreasonably restricting access to a product. Once a royalty fee is negotiated and a time limit set, governments are free to compel the original patent holder to hand over its intellectual property.
The U.S. government routinely grants compulsory licenses for purely commercial reasons, largely to streamline production of consumer electronics and military hardware. Five such licenses were issued in the last year alone, one of them specifically to Abbott. To no one's horror or, frankly, interest, Italy recently issued a compulsory license for a drug that treats enlarged prostates.
Thailand's compulsory license addresses a far starker reality -- in a country of 65 million, 650,000 people (one in every 100) is infected by the AIDS virus. With soaring temperatures -- and refrigeration the exception rather than the rule -- heat-stable drugs such as Kaletra are crucial. Kaletra also has the advantage of low toxicity; for people whose livers have withstood years of harsh antiretroviral treatment, Kaletra is a gentler, but prohibitively priced, passport to life.
Why, then, has the Thai government's attempt to acquire a lifesaving drug run into a wall of corporate indignation and government censure?
The standard answer is that pharmaceutical advances are based on the respect of intellectual property. Without the protective role of patents, the argument goes, drug makers would fail to recover their research-and-development costs and consequently shy away from pursuing new drugs.
The truth is that more than half of all antiretroviral drugs were researched entirely on U.S. government grants. Both lopinavir and ritonavir, the two antiretroviral agents in Kaletra, were researched with public money. "Heck, we paid for them," said James Love, director of the Washington-based Consumer Project on Technology.
The pharmaceutical industry lives in fear of a cheap-drug domino effect. Thailand's compulsory license could inspire the entire continent of Africa -- where 70% of the world's 40 million HIV/AIDS cases are found -- to issue licenses for a series of drugs.
Countries such as Kenya and Uganda, not to mention South Africa, have not only the manufacturing base needed to copy and reproduce drugs for a fraction of their cost, they also have the right. So what's stopping them? "There is a history of trade pressures," Love said. "Very few countries are willing to face such pressures."
Despite death on an unimaginable scale, talk of compulsory licensing remains anathema in most of Africa, so millions of lives are left in the hands of a well-meaning yet ineffectual group of international donors, whose solution to the problem has been to purchase and distribute generic AIDS drugs made in India and Brazil. It's a noble effort, but with pitiful results. Fifteen years after the invention of antiretrovirals, only one in four Africans has access to them.
But it gets worse. For many of those who survived thanks to first-line treatments, the time has come to switch to newer, less-toxic drugs -- all of them patented, none of them even remotely available. "We're starting from zero again," said Buddhima Lokuge, U.S. manager of Doctors Without Borders' "campaign for access to essential medicines." By the time generic competition kicks in for the newer drugs, millions of people will have died unnecessarily.
The AIDS epidemic will constitute the single greatest loss of life in modern history. It is impossible for us in the West to conceive of death on such a scale. Far more difficult to understand, however, is the arbitrary nature of this holocaust: The drugs exist, why can't people have them?
African countries should find the resolve to follow Thailand's example and grant compulsory licenses when they see fit. In so doing, they would put an end to a drug monopoly whose human cost brings shame to us all.
Lara Santoro worked as a journalist in Africa from 1997 to 2004.
SOURCE: Los Angeles Times
http://www.latimes.com/news/opinion/la-oe-santoro9oct09,0,43...
Wednesday, October 03, 2007
Saturday, September 22, 2007
New HIV Drug Info- From Clinical Care Options
CCR5 Antagonists (Maraviroc and Vicriviroc)
CCR5 antagonists block viral binding to the CCR5 chemokine coreceptor. Several CCR5 antagonists have been tested in clinical trials.
In August 2007, maraviroc was approved for use in multidrug-resistant patients with R5-only virus. A phase IIb/III trial of this agent in treatment-experienced patients has been reported.[4,5] A phase IIb/III study of maraviroc in treatment‑naive patients with R5 virus has also been performed, and 48-week results were recently reported.[6]
A second CCR5 antagonist in development is vicriviroc. Week 48 phase IIb data from studies in treatment‑experienced patients with R5 virus have been presented.[7] Phase IIb studies in treatment‑naive patients were stopped by the data and safety monitoring board because of decreased efficacy vs efavirenz‑based therapy and an increased rate of viral tropism change among patients receiving vicriviroc.[8]
Advantages and Disadvantages of CCR5 Antagonists
Based on the data currently available for treatment with CCR5 antagonists, there appear to be certain advantages and disadvantages associated with their use. At this time, efficacy data for these agents show a clear advantage over placebo in treatment-experienced individuals who have R5-only virus detected at entry. Indeed, there are numerous reasons to consider using CCR5 antagonists in the later stages of disease. There will likely be no cross-resistance with other available agents such as NRTIs, NNRTIs, PIs, or enfuvirtide. CCR5 antagonists seem to be well tolerated and are orally administered.
Despite these advantages, data have shown that treatment-experienced patients who are in later stages of disease are more likely to have D/M or X4 virus, a setting in which these drugs have not shown antiretroviral activity. For any individual patient, there may be only a specific window of opportunity to benefit from one of these agents while he or she has R5 virus only, with the chance that D/M or X4-only virus will emerge over time. By contrast, other classes of antiretroviral drugs typically only lose activity when agents from the class are used and resistance develops. It is important to recognize that although short-term safety has been demonstrated in studies to date, it remains possible that pharmacologic blockade of CCR5 may have adverse consequences that become apparent only after long-term use of these drugs. The safety aspects of these drugs as well as the consequences of resistance development need to be assessed with long-term use. There may also be the concern about the emergence of D/M or X4 virus with CCR5 antagonist therapy. Finally, use of these agents will require a test for viral tropism, incurring additional cost.
Integrase Inhibitors
Integrase inhibitors target the viral integrase enzyme, which plays a critical role in the viral life cycle, as discussed in the accompanying module by Daniel R. Kuritzkes, MD. Although integrase inhibitors focus on a novel target enzyme, the principle of enzyme inhibition has been the most commonly used mechanism of antiretroviral therapy. Therefore, evaluating response to these agents should be more straightforward than evaluating agents with other mechanisms of action.
The integrase inhibitors that are the furthest in clinical trial development are raltegravir (formerly MK-0518) and elvitegravir (formerly GS9137). Currently, phase III trials of raltegravir in treatment‑naive and treatment-experienced patients are ongoing, and at the time of writing is being considered by the US Food and Drug Administration (FDA) for approval for use in treatment-experienced patients. Elvitegravir is in phase II development for treatment‑experienced patients.
There are significant differences between these 2 compounds. Raltegravir is metabolized by glucuronidation; therefore, while there are interactions with drugs that are metabolized by the CYP450 system, interactions with that have been observed with other PIs and NNRTIs are not thought to be clinically relevant. By contrast, elvitegravir is metabolized by CYP3A4 and may therefore have significant interactions with other antiretrovirals including PIs, NNRTIs, and possibly CCR5 antagonists. Elvitegravir can be pharmacologically boosted with ritonavir, allowing once-daily dosing, whereas raltegravir must be administered twice daily.
Integrase Inhibitors: Advantages and Disadvantages
The advantages of agents in the integrase inhibitor class are clear. It is a novel class with no known cross‑resistance with other agents. The agents act synergistically in combination with approved agents, at least in vitro. They target the third essential enzyme of HIV. Finally, these drugs can be given orally.
Regarding disadvantages, there are no long‑term data on adverse effects since these agents are relatively new and relatively few patients have been treated to date. Virologic failure appears to be associated with a high likelihood of the emergence of resistance mutations. Moreover, available evidence, although limited to date, suggests that considerable cross-resistance exists between raltegravir and elvitegravir.[20,21] A recent case report described 2 patients who switched from elvitegravir/ritonavir to raltegravir after virologic failure, but experienced no significant reduction in HIV-1 RNA level (Capsule Summary).[22] It is clear that these drugs should be combined with an effective OBR to minimize the risk of resistance and potential cross‑resistance
How Will We Use New Agents in Treatment-Experienced Patients?
Maraviroc has been approved for use in treatment-experienced patients; therefore, candidates for therapy will typically be those with more advanced stages of disease who are more likely to have D/M or X4 virus, a setting in which CCR5 antagonists are likely to have reduced or no activity. Another challenge is that it will be difficult to consider switching to maraviroc as a replacement for other agents in patients whose HIV-1 RNA is suppressed, because testing for viral tropism requires detectable viremia. Therefore, maraviroc is most appropriate for the subset of treatment-experienced patients who are experiencing virologic failure on existing therapy, who have no detectable D/M or X4 virus on a screening test for viral tropism, and who have other active agents available to use as part of an OBR.
Individuals who are treatment naive, on the other hand, are less likely to have a D/M-tropic or X4 virus and, therefore, have a better chance of being candidates for CCR5 antagonist therapy. However, in the recently reported results of the MERIT trial, maraviroc failed to meet criteria for noninferiority to efavirenz for the primary endpoint of HIV-1 RNA < 50 copies/mL. Likewise, a trial of vicriviroc was halted because of inferior efficacy compared with efavirenz in treatment-naive patients. These data suggest that further investigation of the use of maraviroc and vicriviroc in treatment-naive patients maybe needed before they can be considered for use in this patient population
Integrase inhibitors will initially be used for treatment-experienced patients because the largest data sets involve this population of patients. Studies in treatment-naive individuals are also under way, and preliminary data certainly suggest that there may be a role for this class of drugs in these patients. Unlike CCR5 antagonists, there appear to be no specific considerations that argue for earlier or later therapy, since agents in this class should be effective regardless of when the agents are used. Dosing issues may affect the use of integrase inhibitors as initial therapy. For example, raltegravir, the drug that is in the most advanced stage of clinical development, is dosed twice daily whereas once‑daily options are generally favored in the earlier stages of disease and, indeed, throughout treatment. Although elvitegravir is a once-daily drug and can be given with ritonavir, the implications of the use of low-dose ritonavir without another PI must be considered. There is little experience with this particular situation, and the potential risk of selecting for PI resistance if virologic failure occurs must be explored in the future. Consistent with general principles, this class of drugs will be most active when used in conjunction with other active drugs. Therefore, strategic thinking is necessary when considering the introduction of novel drugs into treatment regimens. It is crucial to preserve as many active drugs as possible and to combine these with new drugs, hopefully enabling us to achieve undetectable HIV-1 RNA even in the most treatment‑experienced patients, as recommended in the US Department of Health and Human Services and the International AIDS Society-USA guidelines.
Etravirine, a new second-generation NNRTI, has demonstrated potent activity when combined with other active agents in patients who have experienced virologic failure while receiving efavirenz or nevirapine. Patients who may benefit most from this drug are those who stopped NNRTI-based therapy in the past after developing only 1 or 2 NNRTI resistance mutations, or patients who were not considered candidates for NNRTI-based therapy because of transmitted NNRTI-resistant virus. Those with a greater number of NNRTI mutations may derive less benefit from this agent. The recently reported mutation score may help in identifying which individual patients are most appropriate for this agent. Furthermore, the resistance data emphasize the importance of discontinuing the use of currently approved NNRTIs in a failing regimen to minimize the risk of accumulating multiple NNRTI resistance mutations and developing cross-resistance to next-generation agents. Finally, studies of etravirine have underscored the importance of having an adequate background regimen when using any new and potentially active drug.
CCR5 antagonists block viral binding to the CCR5 chemokine coreceptor. Several CCR5 antagonists have been tested in clinical trials.
In August 2007, maraviroc was approved for use in multidrug-resistant patients with R5-only virus. A phase IIb/III trial of this agent in treatment-experienced patients has been reported.[4,5] A phase IIb/III study of maraviroc in treatment‑naive patients with R5 virus has also been performed, and 48-week results were recently reported.[6]
A second CCR5 antagonist in development is vicriviroc. Week 48 phase IIb data from studies in treatment‑experienced patients with R5 virus have been presented.[7] Phase IIb studies in treatment‑naive patients were stopped by the data and safety monitoring board because of decreased efficacy vs efavirenz‑based therapy and an increased rate of viral tropism change among patients receiving vicriviroc.[8]
Advantages and Disadvantages of CCR5 Antagonists
Based on the data currently available for treatment with CCR5 antagonists, there appear to be certain advantages and disadvantages associated with their use. At this time, efficacy data for these agents show a clear advantage over placebo in treatment-experienced individuals who have R5-only virus detected at entry. Indeed, there are numerous reasons to consider using CCR5 antagonists in the later stages of disease. There will likely be no cross-resistance with other available agents such as NRTIs, NNRTIs, PIs, or enfuvirtide. CCR5 antagonists seem to be well tolerated and are orally administered.
Despite these advantages, data have shown that treatment-experienced patients who are in later stages of disease are more likely to have D/M or X4 virus, a setting in which these drugs have not shown antiretroviral activity. For any individual patient, there may be only a specific window of opportunity to benefit from one of these agents while he or she has R5 virus only, with the chance that D/M or X4-only virus will emerge over time. By contrast, other classes of antiretroviral drugs typically only lose activity when agents from the class are used and resistance develops. It is important to recognize that although short-term safety has been demonstrated in studies to date, it remains possible that pharmacologic blockade of CCR5 may have adverse consequences that become apparent only after long-term use of these drugs. The safety aspects of these drugs as well as the consequences of resistance development need to be assessed with long-term use. There may also be the concern about the emergence of D/M or X4 virus with CCR5 antagonist therapy. Finally, use of these agents will require a test for viral tropism, incurring additional cost.
Integrase Inhibitors
Integrase inhibitors target the viral integrase enzyme, which plays a critical role in the viral life cycle, as discussed in the accompanying module by Daniel R. Kuritzkes, MD. Although integrase inhibitors focus on a novel target enzyme, the principle of enzyme inhibition has been the most commonly used mechanism of antiretroviral therapy. Therefore, evaluating response to these agents should be more straightforward than evaluating agents with other mechanisms of action.
The integrase inhibitors that are the furthest in clinical trial development are raltegravir (formerly MK-0518) and elvitegravir (formerly GS9137). Currently, phase III trials of raltegravir in treatment‑naive and treatment-experienced patients are ongoing, and at the time of writing is being considered by the US Food and Drug Administration (FDA) for approval for use in treatment-experienced patients. Elvitegravir is in phase II development for treatment‑experienced patients.
There are significant differences between these 2 compounds. Raltegravir is metabolized by glucuronidation; therefore, while there are interactions with drugs that are metabolized by the CYP450 system, interactions with that have been observed with other PIs and NNRTIs are not thought to be clinically relevant. By contrast, elvitegravir is metabolized by CYP3A4 and may therefore have significant interactions with other antiretrovirals including PIs, NNRTIs, and possibly CCR5 antagonists. Elvitegravir can be pharmacologically boosted with ritonavir, allowing once-daily dosing, whereas raltegravir must be administered twice daily.
Integrase Inhibitors: Advantages and Disadvantages
The advantages of agents in the integrase inhibitor class are clear. It is a novel class with no known cross‑resistance with other agents. The agents act synergistically in combination with approved agents, at least in vitro. They target the third essential enzyme of HIV. Finally, these drugs can be given orally.
Regarding disadvantages, there are no long‑term data on adverse effects since these agents are relatively new and relatively few patients have been treated to date. Virologic failure appears to be associated with a high likelihood of the emergence of resistance mutations. Moreover, available evidence, although limited to date, suggests that considerable cross-resistance exists between raltegravir and elvitegravir.[20,21] A recent case report described 2 patients who switched from elvitegravir/ritonavir to raltegravir after virologic failure, but experienced no significant reduction in HIV-1 RNA level (Capsule Summary).[22] It is clear that these drugs should be combined with an effective OBR to minimize the risk of resistance and potential cross‑resistance
How Will We Use New Agents in Treatment-Experienced Patients?
Maraviroc has been approved for use in treatment-experienced patients; therefore, candidates for therapy will typically be those with more advanced stages of disease who are more likely to have D/M or X4 virus, a setting in which CCR5 antagonists are likely to have reduced or no activity. Another challenge is that it will be difficult to consider switching to maraviroc as a replacement for other agents in patients whose HIV-1 RNA is suppressed, because testing for viral tropism requires detectable viremia. Therefore, maraviroc is most appropriate for the subset of treatment-experienced patients who are experiencing virologic failure on existing therapy, who have no detectable D/M or X4 virus on a screening test for viral tropism, and who have other active agents available to use as part of an OBR.
Individuals who are treatment naive, on the other hand, are less likely to have a D/M-tropic or X4 virus and, therefore, have a better chance of being candidates for CCR5 antagonist therapy. However, in the recently reported results of the MERIT trial, maraviroc failed to meet criteria for noninferiority to efavirenz for the primary endpoint of HIV-1 RNA < 50 copies/mL. Likewise, a trial of vicriviroc was halted because of inferior efficacy compared with efavirenz in treatment-naive patients. These data suggest that further investigation of the use of maraviroc and vicriviroc in treatment-naive patients maybe needed before they can be considered for use in this patient population
Integrase inhibitors will initially be used for treatment-experienced patients because the largest data sets involve this population of patients. Studies in treatment-naive individuals are also under way, and preliminary data certainly suggest that there may be a role for this class of drugs in these patients. Unlike CCR5 antagonists, there appear to be no specific considerations that argue for earlier or later therapy, since agents in this class should be effective regardless of when the agents are used. Dosing issues may affect the use of integrase inhibitors as initial therapy. For example, raltegravir, the drug that is in the most advanced stage of clinical development, is dosed twice daily whereas once‑daily options are generally favored in the earlier stages of disease and, indeed, throughout treatment. Although elvitegravir is a once-daily drug and can be given with ritonavir, the implications of the use of low-dose ritonavir without another PI must be considered. There is little experience with this particular situation, and the potential risk of selecting for PI resistance if virologic failure occurs must be explored in the future. Consistent with general principles, this class of drugs will be most active when used in conjunction with other active drugs. Therefore, strategic thinking is necessary when considering the introduction of novel drugs into treatment regimens. It is crucial to preserve as many active drugs as possible and to combine these with new drugs, hopefully enabling us to achieve undetectable HIV-1 RNA even in the most treatment‑experienced patients, as recommended in the US Department of Health and Human Services and the International AIDS Society-USA guidelines.
Etravirine, a new second-generation NNRTI, has demonstrated potent activity when combined with other active agents in patients who have experienced virologic failure while receiving efavirenz or nevirapine. Patients who may benefit most from this drug are those who stopped NNRTI-based therapy in the past after developing only 1 or 2 NNRTI resistance mutations, or patients who were not considered candidates for NNRTI-based therapy because of transmitted NNRTI-resistant virus. Those with a greater number of NNRTI mutations may derive less benefit from this agent. The recently reported mutation score may help in identifying which individual patients are most appropriate for this agent. Furthermore, the resistance data emphasize the importance of discontinuing the use of currently approved NNRTIs in a failing regimen to minimize the risk of accumulating multiple NNRTI resistance mutations and developing cross-resistance to next-generation agents. Finally, studies of etravirine have underscored the importance of having an adequate background regimen when using any new and potentially active drug.
Tuesday, September 18, 2007
Facial Reconstruction Options in the Us- Sept 2007
These are some contacts
Silikon 1000 : http://www.derekjones.com or www.resderm.com or http://www.orentreich.com/ (use off label in the US)
Bioalcamid in Canada (several cities) http://www.faceforward.ca/ or Mexico (monterrey)
egarzaskin@yahoo.com (not FDA approved in the US yet)
PMMA in Mexico (tijuana) luis_casavantes@msn.com ( product approved in the US: Artefill, but very expensive!)
Sculptra : http://sculptra.com/US/Index.jsp (FDA approved for HIV lipoatrophy)
Radiesse: radiesse.com (FDA approved for HIV lipoatrophy)
Helpful Links
http://www.atdn.org/ - AIDS treatment Data Network (ARDN)
http://www.aidsmap.com - Information on HIV and AIDS
http://www.acria.org/treatment/treatment_edu_forumnov800.html - ARCIA (AIDS Community Research Initiative of America)
http://www.facialwasting.org - Useful information about facial wasting and facial wasting treatments
http://www.projinf.org/fs/lipo.html - Comprehensive information about lipodystrophy syndrome
http://www.sculptra.com - Information about the facial wasting facial filler SCULPTRA™ (also known in Europe as New-Fill or in the US as Nu-Fill)
http://www.bioforminc.com/US/radiesse/products.htm - Information about the facial filler Radiesse™ (formerly knows as Radiance™)
http://www.restylane.com/ - Information about the facial filler Restylane®
http://www.perlane-information.com/ - Website about the facial filler Perlane®
http://www.csa.za.org - Center for the study of AIDS
http://www.thebody.com/treat/facial_wasting.html - Articles on facial wasting treatments
Health Insurance Resources for HIV Positive People (non ADAP)
The Georgetown University Health Policy Institute has written A CONSUMER GUIDE FOR GETTING AND KEEPING HEALTH INSURANCE for each state and the District of Columbia — fifty-one in all. These Consumer Guides are available at this web site and will be updated periodically as changes in federal and state policy warrant.
http://healthinsuranceinfo.net/
I hear this broker may find you an insurance policy under HIPPA is you are losing your insurance (you have 61 days to switch otherwise you will be limited by pre-existing conditions)
http://www.ehealthinsurance.com/
Also, president Clinton passed a bill to require high risk pools in different states, but some states like Georgia and Florida decided not to join. Here are the states that provide health insurance to people with pre-existing conditions:
States That Have Risk Pools:
Alabama (for portability only)
Alabama Health Insurance Plan
Phone 1-800-513-1384 or (334) 353-8924
Alaska
Alaska Comprehensive Health Insurance Association
Phone 1-800-467-8725 or (907) 269-7900
Arkansas
Arkansas Comprehensive Health Insurance Pool
Phone 1-800-285-6477
California
California Major Risk Medical Insurance Program
Phone 1-800-289-6574 or (916) 324-4695
Colorado
CoverColorado
Phone (303) 863-1960
Connecticut
Connecticut Health Reinsurance Association
Phone 1-800-842-0004
Florida (not open for new enrollees)
Phone (850) 309-1200
Idaho
Idaho Individual High Risk Reinsurance Pool
Illinois
Illinois Comprehensive Health Insurance Plan
Phone 1-800-367-6410 or (217) 782-6333
Indiana
Indiana Comprehensive Health Association
Phone 1-800-552-7921 or (317) 614-2000
Iowa
Iowa Comprehensive Health Association
Phone (877) 793-6880
Kansas
Kansas Health Insurance Association
Phone 1-800-290-1366 or (316) 792-1779
Kentucky
Kentucky Access
Phone (866) 405-6145
Louisiana
Louisiana Health Insurance Association
Phone 1-800-736-0947 or (504) 926-6245
Maryland
Maryland Health Insurance Plan
Phone (888) 444-9016
Minnesota
Minnesota Comprehensive Health Association
Phone (952) 593-9609
Mississippi
Mississippi Comprehensive Health Insurance Risk Pool
Phone (601) 362-0799
Missouri
Missouri Health Insurance Pool
Phone 1-800-843-6447 (All but NW Missouri)
Phone 1-800-645-8346 (NW Missouri)
Montana
Montana Comprehensive Health Insurance Association
Phone (406) 444-8200
Nebraska
Nebraska Comprehensive Health Association
Phone (402) 343-3574 or (877) 348-4304
New Hampshire
New Hampshire Health Plan
Phone (800) 578-3272
New Mexico
New Mexico Medical Insurance Pool
Phone (505) 622-4711
North Dakota
Comprehensive Health Association Of North Dakota
Phone 1-800-737-0016 or (701) 282-1235
Oklahoma
Oklahoma Health Insurance High Risk Pool
Phone 1-800-255-6065 or (913) 362-0040
Oregon
Oregon Medical Insurance Pool
Phone (503) 373-1692
South Carolina
South Carolina Health Insurance Pool
Phone 1-800-868-2500, ext. 42757, or 1-803-788-0500,
ext. 42757
South Dakota
South Dakota Risk Pool
Tennessee
TennCare Program
Contact Tennessee area county medical assistance offices, or
Phone (615) 741-8642
Texas
Texas Health Insurance Risk Pool
Phone 1-888-398-3927
Utah
Utah Comprehensive Health Insurance Pool
Phone 1-800-705-9173 or (801) 442-6660
Washington
Washington State Health Insurance Pool
Phone 1-800-877-5187
West Virginia
AccessWV
Phone 1-866-445-8491
Wisconsin
Wisconsin Health Insurance Risk Sharing Plan
Phone (608) 441-5777
Wyoming
Wyoming Health Insurance Pool
Phone (307) 634-1393
http://healthinsuranceinfo.net/
I hear this broker may find you an insurance policy under HIPPA is you are losing your insurance (you have 61 days to switch otherwise you will be limited by pre-existing conditions)
http://www.ehealthinsurance.com/
Also, president Clinton passed a bill to require high risk pools in different states, but some states like Georgia and Florida decided not to join. Here are the states that provide health insurance to people with pre-existing conditions:
States That Have Risk Pools:
Alabama (for portability only)
Alabama Health Insurance Plan
Phone 1-800-513-1384 or (334) 353-8924
Alaska
Alaska Comprehensive Health Insurance Association
Phone 1-800-467-8725 or (907) 269-7900
Arkansas
Arkansas Comprehensive Health Insurance Pool
Phone 1-800-285-6477
California
California Major Risk Medical Insurance Program
Phone 1-800-289-6574 or (916) 324-4695
Colorado
CoverColorado
Phone (303) 863-1960
Connecticut
Connecticut Health Reinsurance Association
Phone 1-800-842-0004
Florida (not open for new enrollees)
Phone (850) 309-1200
Idaho
Idaho Individual High Risk Reinsurance Pool
Illinois
Illinois Comprehensive Health Insurance Plan
Phone 1-800-367-6410 or (217) 782-6333
Indiana
Indiana Comprehensive Health Association
Phone 1-800-552-7921 or (317) 614-2000
Iowa
Iowa Comprehensive Health Association
Phone (877) 793-6880
Kansas
Kansas Health Insurance Association
Phone 1-800-290-1366 or (316) 792-1779
Kentucky
Kentucky Access
Phone (866) 405-6145
Louisiana
Louisiana Health Insurance Association
Phone 1-800-736-0947 or (504) 926-6245
Maryland
Maryland Health Insurance Plan
Phone (888) 444-9016
Minnesota
Minnesota Comprehensive Health Association
Phone (952) 593-9609
Mississippi
Mississippi Comprehensive Health Insurance Risk Pool
Phone (601) 362-0799
Missouri
Missouri Health Insurance Pool
Phone 1-800-843-6447 (All but NW Missouri)
Phone 1-800-645-8346 (NW Missouri)
Montana
Montana Comprehensive Health Insurance Association
Phone (406) 444-8200
Nebraska
Nebraska Comprehensive Health Association
Phone (402) 343-3574 or (877) 348-4304
New Hampshire
New Hampshire Health Plan
Phone (800) 578-3272
New Mexico
New Mexico Medical Insurance Pool
Phone (505) 622-4711
North Dakota
Comprehensive Health Association Of North Dakota
Phone 1-800-737-0016 or (701) 282-1235
Oklahoma
Oklahoma Health Insurance High Risk Pool
Phone 1-800-255-6065 or (913) 362-0040
Oregon
Oregon Medical Insurance Pool
Phone (503) 373-1692
South Carolina
South Carolina Health Insurance Pool
Phone 1-800-868-2500, ext. 42757, or 1-803-788-0500,
ext. 42757
South Dakota
South Dakota Risk Pool
Tennessee
TennCare Program
Contact Tennessee area county medical assistance offices, or
Phone (615) 741-8642
Texas
Texas Health Insurance Risk Pool
Phone 1-888-398-3927
Utah
Utah Comprehensive Health Insurance Pool
Phone 1-800-705-9173 or (801) 442-6660
Washington
Washington State Health Insurance Pool
Phone 1-800-877-5187
West Virginia
AccessWV
Phone 1-866-445-8491
Wisconsin
Wisconsin Health Insurance Risk Sharing Plan
Phone (608) 441-5777
Wyoming
Wyoming Health Insurance Pool
Phone (307) 634-1393
Thursday, September 13, 2007
The New Wave of HIV Drugs is Here
The New Wave of HIV Drugs is Here
For the first time in 10 years, HIV+ patients will have access to two new HIV drug classes. Patients with ongoing viral replication that have been failing current medicines will have a "second chance" to control their HIV by starting new drugs to which their virus has not mutated and become resistant. It is estimated that 20 % of the half a million patients taking HIV medications in the US are not responding to their meds and have ongoing viral replication in their bodies that may shorten their life spans and also make them more infectious to others.
No single HIV medication can control HIV by itself, needing at least two more in combination. But many people have HIV that has developed multidrug resistance (MDR) by mutating around medicines, which allows the virus to aggressively kill the CD4 cells that "direct" the immune system's response against invaders. MDR patients need to start at least 2-3 "active" drugs that their virus has never seen, but most have not had that luxury in the past few years due to drug approvals that did not happen cocurrently. Fortunately, two new drugs that work in completely new ways are making this possibility a reality for the first time since protease inhibitors were introduced to the market 10 years ago. A new entry inhibitor (Maraviroc , trade name: Selzentry) that works at attempting to block the attachment of HIV to the CD4 T cell, and the first integrase inhibitor (Raltegravir, trade name: Isentress) that works inside the nucleus of the CD4 cell, provide effective new targets to attack the virus. The most critical thing right now is to educate physicians and patients on how to best use these new drugs so that their benefits at lowering viral load to undetectable levels are sustained until a cure is found. Other medications like Fuzeon ( an approved fusion inhibitor), Aptivus and Prezista ( approved second generation protease inhibitors), and TMC 125 ( a second generation non nucleoside analog in expanded access) can be combined with the two novel agents approved this year to hit the virus in different parts of its life cycle outside and inside the CD4 cell.
"I recently started Raltegravir with two other active medicines and my viral load has become undectable for the first time in many years", said Sharon Braiteh of Houston." I just pray that my viral load is controlled for a long time so that my immune system can be restored for my body to fight my current cancer and infections", added Braiteh.
"This is the second wave of HAART (highly active antiretroviral therapy) that will save a lot of lives", said long term survivor , activist and educator Nelson Vergel. " I urge patients not to screw up this last chance to get an effective combination before we go through another dry period of no new drugs in the coming few years...It is imperative to do your homework before jumping into a new regimen with limited data", added Vergel.
Nelson Vergel will be giving the last update for this year on recent conferences that had new data on these and other emerging options for HIV treatment. His lecture will be held on
Monday, September 17
Grady Infectious Disease Program
341 Ponce de Leon Ave
Atlanta, GA 30308
Advance Reservations are required.
Register by calling Positive Impact at 404-589-9040
You may also e-mail:
training@PositiveImpact-atl.org
More information on new HIV medications can be found at Nelson's web site www.SalvageTherapies.org
For the first time in 10 years, HIV+ patients will have access to two new HIV drug classes. Patients with ongoing viral replication that have been failing current medicines will have a "second chance" to control their HIV by starting new drugs to which their virus has not mutated and become resistant. It is estimated that 20 % of the half a million patients taking HIV medications in the US are not responding to their meds and have ongoing viral replication in their bodies that may shorten their life spans and also make them more infectious to others.
No single HIV medication can control HIV by itself, needing at least two more in combination. But many people have HIV that has developed multidrug resistance (MDR) by mutating around medicines, which allows the virus to aggressively kill the CD4 cells that "direct" the immune system's response against invaders. MDR patients need to start at least 2-3 "active" drugs that their virus has never seen, but most have not had that luxury in the past few years due to drug approvals that did not happen cocurrently. Fortunately, two new drugs that work in completely new ways are making this possibility a reality for the first time since protease inhibitors were introduced to the market 10 years ago. A new entry inhibitor (Maraviroc , trade name: Selzentry) that works at attempting to block the attachment of HIV to the CD4 T cell, and the first integrase inhibitor (Raltegravir, trade name: Isentress) that works inside the nucleus of the CD4 cell, provide effective new targets to attack the virus. The most critical thing right now is to educate physicians and patients on how to best use these new drugs so that their benefits at lowering viral load to undetectable levels are sustained until a cure is found. Other medications like Fuzeon ( an approved fusion inhibitor), Aptivus and Prezista ( approved second generation protease inhibitors), and TMC 125 ( a second generation non nucleoside analog in expanded access) can be combined with the two novel agents approved this year to hit the virus in different parts of its life cycle outside and inside the CD4 cell.
"I recently started Raltegravir with two other active medicines and my viral load has become undectable for the first time in many years", said Sharon Braiteh of Houston." I just pray that my viral load is controlled for a long time so that my immune system can be restored for my body to fight my current cancer and infections", added Braiteh.
"This is the second wave of HAART (highly active antiretroviral therapy) that will save a lot of lives", said long term survivor , activist and educator Nelson Vergel. " I urge patients not to screw up this last chance to get an effective combination before we go through another dry period of no new drugs in the coming few years...It is imperative to do your homework before jumping into a new regimen with limited data", added Vergel.
Nelson Vergel will be giving the last update for this year on recent conferences that had new data on these and other emerging options for HIV treatment. His lecture will be held on
Monday, September 17
Grady Infectious Disease Program
341 Ponce de Leon Ave
Atlanta, GA 30308
Advance Reservations are required.
Register by calling Positive Impact at 404-589-9040
You may also e-mail:
training@PositiveImpact-atl.org
More information on new HIV medications can be found at Nelson's web site www.SalvageTherapies.org
When You Have to Fire Your Doctor
Positively Aware July/August 2007
You’re Fired!
Changing your doctor
by Matt Sharp
Donald Trump’s irritating voice rang in my ears as I stormed home from one of the most humiliating experiences as a “patient” in my 20 years of receiving HIV care. The details of the situation are not as important as the light bulb that went off in my head to rectify the situation.
The light bulb told me it was time to fire my doctor! I asked myself, “Do I really want to go through the hassle of finding and transitioning to a new provider?” Everything was going okay until I realized that I may have been getting a little too cozy and comfortable with him. I also wasn’t getting the complete care I needed, but only casual and acute care. After a sleepless night, I finally came to the decision that the time was right for making a change, especially given that this particular ordeal was the catalyst for the termination of my doctor. Firing your doctor can be traumatic!
Read more here:
http://tpan.com/publications/pa/07_04/get_sharp.shtml
You’re Fired!
Changing your doctor
by Matt Sharp
Donald Trump’s irritating voice rang in my ears as I stormed home from one of the most humiliating experiences as a “patient” in my 20 years of receiving HIV care. The details of the situation are not as important as the light bulb that went off in my head to rectify the situation.
The light bulb told me it was time to fire my doctor! I asked myself, “Do I really want to go through the hassle of finding and transitioning to a new provider?” Everything was going okay until I realized that I may have been getting a little too cozy and comfortable with him. I also wasn’t getting the complete care I needed, but only casual and acute care. After a sleepless night, I finally came to the decision that the time was right for making a change, especially given that this particular ordeal was the catalyst for the termination of my doctor. Firing your doctor can be traumatic!
Read more here:
http://tpan.com/publications/pa/07_04/get_sharp.shtml
Should pharmaceutical employees be allowed to lecture about their products?
I am seeing a very strong trend of allowing pharmaceutical employees to speak to clinician and patient groups about their products in lectures set up by industry. I have attended many CME based and non CME lectures and I can say that I have hardly seen a neutral or unbiased lecture when a pharma employee delivers the message. What happened with allowing private investigators from medical schools, private practice and the public sector to speak instead?
I think it is time to put an end to this trend. The FDA should monitor this behavior and mandate that companies use neutral third parties to deliver treatment information to clinicians and patients.
It would be nice to see all pharmaceutical companies donate money to a large educational entity from medical schools or other venues so that a conglomerate of funding is placed in a pool that would be used for setting up educational programs for clinicians and patients. This entity would be audited yearly by an ethics and content review panel so that information is kept unbiased and all useful public domain information is provided to people who would benefit from it without selectively choosing what data sets to use to drive a message.
I know this is possible!
I think it is time to put an end to this trend. The FDA should monitor this behavior and mandate that companies use neutral third parties to deliver treatment information to clinicians and patients.
It would be nice to see all pharmaceutical companies donate money to a large educational entity from medical schools or other venues so that a conglomerate of funding is placed in a pool that would be used for setting up educational programs for clinicians and patients. This entity would be audited yearly by an ethics and content review panel so that information is kept unbiased and all useful public domain information is provided to people who would benefit from it without selectively choosing what data sets to use to drive a message.
I know this is possible!
Friday, August 31, 2007
New Booklet for Salvage Patients by Dr Paul Bellman- NYC
Paul Bellman is one of the most concerned doctors in the US on the subject of how to rescue HIV patients who have ran out of options. Here is a manuscript he wrote for patients and medical students on the subject that I highly recommend for all to read:
http://salvagetherapies.org/articals/salvageTreatment_ManualDrBellmanAug07.pdf
http://salvagetherapies.org/articals/salvageTreatment_ManualDrBellmanAug07.pdf
Are we losing mental capacity in HIV?
This study really worries me. Median CD4 cells were in the 400, and half were naive. So these are not sick patients. I wish they had defined what mild cognitive impairment is. I forget faces, names, things to do, sometimes important personal data, etc. At 48 years old, I have the feeling that this is not normal. Studies like this one just feed that concern....
They say that may be most of the HIV meds we are taking may not be penetrating the central nervous system as well as they should, and thus we may be losing mental capacity with time.
I wonder if anyone is doing studies with the use of Alzheimer drugs for HIV related cognitive impairment....
Link:The prevalence and incidence of neurocognitive impairment in the HAART era (08/30/07)
The study conclusions:
"....By the most conservative estimate, an assessment of neurocognitive function revealed that 26% of subjects selected from the ALLRT study were cognitively impaired at their baseline Neuroscreen....226 (58%) had a follow-up visit at which their test scores indicated they were neurologically unimpaired. This may be related to the favorable effects of HAART on neurological function
There was a relationship between immunological status and prevalent neurocognitive impairment, but we did not find substantial evidence to suggest that virological factors were associated with prevalent neurocognitive impairment....
the observed decline in neurocognitive functioning despite ART is consistent with the hypothesis that viral replication in the CNS may not be well controlled in some patients treated with HAART, perhaps because antiretroviral drugs may not penetrate adequately into the CNS..."
They say that may be most of the HIV meds we are taking may not be penetrating the central nervous system as well as they should, and thus we may be losing mental capacity with time.
I wonder if anyone is doing studies with the use of Alzheimer drugs for HIV related cognitive impairment....
Link:The prevalence and incidence of neurocognitive impairment in the HAART era (08/30/07)
The study conclusions:
"....By the most conservative estimate, an assessment of neurocognitive function revealed that 26% of subjects selected from the ALLRT study were cognitively impaired at their baseline Neuroscreen....226 (58%) had a follow-up visit at which their test scores indicated they were neurologically unimpaired. This may be related to the favorable effects of HAART on neurological function
There was a relationship between immunological status and prevalent neurocognitive impairment, but we did not find substantial evidence to suggest that virological factors were associated with prevalent neurocognitive impairment....
the observed decline in neurocognitive functioning despite ART is consistent with the hypothesis that viral replication in the CNS may not be well controlled in some patients treated with HAART, perhaps because antiretroviral drugs may not penetrate adequately into the CNS..."
Wednesday, August 29, 2007
Be Aware of TMC 125 (Etravirine, Tibotec new non nucleoside) limitations
If you are thinking about obtaining TMC 125 (Etravirine, a new non nucleoside yet to be approved) via Tibotec's expanded access program (EAP) and you have developed resistance to non nucleosides in the past (Sustiva, Viramune, Rescriptor), be aware that it is very difficult to know if TMC 125 will work for your virus since the mutations that predict its efficacy may not be present in your genotype. Non nucleoside old mutations are "archived" and may not show up in your current genotype or phenotype tests. In fact, many people with past non nucleoside resistance show complete sensitivity to non-nucleosides years after developing resistance and not using that drug class. Doctors sometimes try to search old charts to see if they can pull out old genotype test results from a time when the patient was on non-nucleosides and failing. In many instances, that information is not found. We are also learning that TMC 125 specific mutations were not included in genotype tests years ago, so looking for old patient charts may be a moot subject.
We know from studies so far that TMC 125 is not effective in people with previously accumulated and extensive NNRTI resistance, but it can still work in those with more limited mutations.
My suggestion is that if you are going to start TMC 125, make sure that you are not gambling about assuming drug sensitivity, so NEVER start it with only one fully active agent but TWO. This will ensure that you have enough of an active background for viral suppression and sustained response in case that you may not have sensitivity to TMC 125.
Possible combinations :
No resistance to Prezista but resistance to Fuzeon: Darunavir (Prezista) + TMC 125 + Raltegravir (Merck integrase available via expanded access as of Aug 2007) + nukes (approved agents + two EAPs)
If you have resistance to Prezista and Fuzeon and have an R5 tropic virus: Maraviroc+ TMC 125+ Raltegravir + nukes (approved agents + two EAPs)
If you do not have resistance to Fuzeon or Prezista: Fuzeon + TMC 125 + Prezista + nukes ( all approved agents + one EAP)
If you have resistance to Prezista but not Fuzeon: Fuzeon + TMC 125 + raltegravir (approved agents plus two EAPs)
If you do not have a R5 only tropic virus and have resistance to Fuzeon and Prezista: TMC 125 + raltegravir + ???...you may want to wait
If you have resistance to Prezista, Fuzeon, and have a R5 tropic virus: TMC 125 + Maraviroc +raltegravir
A lot of these combinations have not been fully researched. So far, we have some knowledge of interaction data between these agents and the only contraindication that I have seen is TMC 125 + Tipranavir (Aptivus)
Message: a new agent may not be an active agent, so be cautious and combine agents in such a way that you do not take too many chances. Make sure that you have a doctor who knows the data on these agents, potential interactions, and how to deal with lacking resistance information.
We know from studies so far that TMC 125 is not effective in people with previously accumulated and extensive NNRTI resistance, but it can still work in those with more limited mutations.
My suggestion is that if you are going to start TMC 125, make sure that you are not gambling about assuming drug sensitivity, so NEVER start it with only one fully active agent but TWO. This will ensure that you have enough of an active background for viral suppression and sustained response in case that you may not have sensitivity to TMC 125.
Possible combinations :
No resistance to Prezista but resistance to Fuzeon: Darunavir (Prezista) + TMC 125 + Raltegravir (Merck integrase available via expanded access as of Aug 2007) + nukes (approved agents + two EAPs)
If you have resistance to Prezista and Fuzeon and have an R5 tropic virus: Maraviroc+ TMC 125+ Raltegravir + nukes (approved agents + two EAPs)
If you do not have resistance to Fuzeon or Prezista: Fuzeon + TMC 125 + Prezista + nukes ( all approved agents + one EAP)
If you have resistance to Prezista but not Fuzeon: Fuzeon + TMC 125 + raltegravir (approved agents plus two EAPs)
If you do not have a R5 only tropic virus and have resistance to Fuzeon and Prezista: TMC 125 + raltegravir + ???...you may want to wait
If you have resistance to Prezista, Fuzeon, and have a R5 tropic virus: TMC 125 + Maraviroc +raltegravir
A lot of these combinations have not been fully researched. So far, we have some knowledge of interaction data between these agents and the only contraindication that I have seen is TMC 125 + Tipranavir (Aptivus)
Message: a new agent may not be an active agent, so be cautious and combine agents in such a way that you do not take too many chances. Make sure that you have a doctor who knows the data on these agents, potential interactions, and how to deal with lacking resistance information.
Sunday, July 29, 2007
The End of Nandrolone ?
The End of Nandrolone
Nelson Vergel, Program for Wellness Restoration
http://www.gmhc.org/health/treatment/ti/ti21_1.html
The current terrain for wasting patients in the era of HAART On March 20, 2007, Watson Laboratories stopped the production of nandrolone decanoate (old brand name: Deca Durabolin), a low-cost injectable anabolic steroid used for HIV wasting, citing the lack of raw-material suppliers for the product. Patients found out when they went to their pharmacies for a prescription a week later.
Although there are other makers of generic nandrolone internationally (easily located on the Internet), this offers little help to U.S. patients. Anabolic steroids and testosterone are designated by the Drug Enforcement Administration (DEA) of the U.S. Department of Justice as Class III drugs, which are illegal to import even for personal and medical uses.
Over the past 20 years, anabolic steroids have suffered from a lot of bad publicity and misconceptions due to their use in sports and bodybuilding. However, that did not stop activists in the 1990s from convincing doctors and researchers to look into these medicines to help those with HIV-related wasting syndrome. Since then, more than eight studies have been performed that showed nandrolone and oxandrolone (brand name Oxandrin, an oral anabolic steroid) to be effective and safe for increasing lean body mass (LBM) and strength in men and women with HIV. Many physicians quickly learned how to prescribe them and monitor their use for helping their HIV-positive patients to survive what used to be one of the main causes of AIDS mortality.
While Watson was abandoning nandrolone, another company was making a decision that would also limit options for HIV wasting patients. Savient Pharmaceuticals informed patients in April 2007 that it had stopped its 10-year-old patient assistance program (PAP) that gave free Oxandrin (oxandrolone) to HIV patients with no insurance or third-party payment sources. Oxandrin has been shown to be mildly effective in men, women, and children with HIV wasting. It can be taken by mouth daily, while nandrolone must be injected in the butt once a week. Whereas Oxandrin has been approved for the treatment of unintentional weight loss, nandrolone's use for HIV wasting was off-label (it was approved for the treatment of anemia in individuals with kidney problems). However, Oxandrin costs $1,300 a month for a 20 mg/day regimen, compared to around $200 a month for 200 mg/week for nandrolone.
Savient's PAP was set up by BTG Pharmaceuticals (bought out by Savient later on) in 1996 after activists pressured the company to provide the drug for free to those with no access or means. As with nandrolone, only 13 states include Oxandrin in their AIDS Drug Assistance Programs (ADAPs). The termination of Savient's PAP means many patients will have no way to afford this drug. The company informed patients that Watson would sell generic Oxandrin, thus eliminating the need for its PAP. Unfortunately, the generic price for Oxandrin sold by Watson is no different than that for the brand-name product, which will continue to be sold by Savient. Watson will not provide free Oxandrin via a PAP either. This is the first time in AIDS history that a company has stopped a PAP while still selling the drug.
Cost is not the only consideration. Unlike nandrolone, Oxadrin can increase liver enzymes and could be problematic for people with liver disease, or for people taking medications that heavily affect the liver, such as the HIV medication Reyataz, and drugs for those with hepatitis B and C. "The decisions of these two companies have a huge impact on many of my patients' health," says Dr. Richard Loftus, a San Francisco physician with a large HIV practice. "We use nandrolone extensively in patients who have problems gaining weight and who feel fatigued, even with undetectable viral loads. Many of my patients feel better and have experienced no side effects at the doses we use."
In the 1980s researcher Dr. Donald Kotler found that the loss of lean body mass can dramatically decrease survival in HIV-positive people.1 Even though the incidence of wasting syndrome has declined dramatically since protease inhibitors were introduced 10 years ago, many people still need extra help to hang on to their muscle to sustain health and productivity. A study performed at Tufts University School of Medicine reported that as many as 29% of people with HIV in the era of HAART are still losing weight or lean body mass, despite undetectable viral loads.2
Dr. Nathan Sherlock knows first hand about the importance of nandrolone for his health and that of his partner:
"My partner has had a significant problem with wasting due to AIDS and the only way he has been able to stop the dangerous weight loss is to use anabolic steroids. He is also hepatitis B positive. His doctor first prescribed Oxandrin in 1998. Within a couple of weeks he had chemical induced hepatitis with the symptoms of nausea, vomiting, loss of appetite and jaundice. His liver enzymes were all elevated. He stopped Oxandrin and the symptoms promptly resolved. His doctor then prescribed nandrolone 200mg/week and he regained weight back to his norm with no side effects. When he stops taking it the wasting returns so he has been on nandrolone for close to 9 years now...I have been taking nandrolone for wasting due to AIDS for over 10 years. Every time I have stopped taking nandrolone I experience rapid weight loss that can only be reversed by resuming the use of nandrolone."
Al Benson, an HIV treatment advocate in Los Angeles concurs. "Nandrolone is truly 'the Lazarus drug'... it has brought me back from the brink, restored my health and made all the difference in the quality of my life."
Other HIV Wasting drugsThe Food and Drug Administration (FDA) has approved other drugs for the treatment of HIV wasting or appetite loss. Megace (megestrol acetate), a female sex hormone-based product, tends to produce weight gain by increasing fat rather than lean body mass. Adding fat during AIDS wasting has not been shown to improve survival. Megace has also been associated with side effects such as diabetes, blood clots, impotence, and the development of female sex characteristics.
Serostim, a recombinant human growth hormone, requires daily injections and can cause joint aches, swelling, and diabetes. It can cost as much as $6,000 a month, so most insurance companies do not want to pay for it and many ADAPs can't. The kickback scandal Serostim's manufacturer was involved in hasn't helped matters either. FDA-approved appetite stimulants such as Marinol contain THC, the psychoactive ingredient in marijuana. This can be an issue for many people with HIV who are in recovery. It has also been suggested that Marinol may simply owe its ability to increase appetite and weight to a side effect of the THC high — "the munchies."
Compounding Pharmacies:a Viable Option at Risk?Many doctors and patients do not know that nandrolone and oxandrolone can also be obtained in smaller quantities legally by prescription and at a lower cost through compounding pharmacies (where drugs are not only dispensed but can be prepared according to a doctor's specifications). No one knows how much longer this option will remain available. One pharmacy owner reports that the DEA has raided several compounding pharmacies in the past few months, including his own. The Safe Compounding Drug Act of 2007, now under consideration, would place these sites under greater regulation and presumably greater surveillance. In the meantime, compounding pharmacies such as Applied Pharmacy, Kronos, the Compounding Shop, College Pharmacy, and others are still economical sources of nandrolone, oxandrolone, and testosterone gels and injections. However, they do not process insurance claims and are not equipped to supply ADAPs, insurance, Medicaid, or Medicare Part D vendors.
In this era when HIV/AIDS patients are living longer, it is just as critical to fight for safe, effective, and affordable "quality of life" drugs as it to advocate for accessible antiretrovirals. After all we have done as activists to secure antiwasting medications, we must not lose ground now and fall asleep when vital treatments such as nandrolone are dropped without notice and with little regard for patients' needs.
For more information or to find out how to get involved, please visit.
Kotler DP, Tierney AR, Wang J, Pierson RN Jr., "Magnitude of body-cell-mass depletion and the timing of death from wasting in AIDS," Am J Clin Nutr. 1989 Sep; 50(3):444-7. "The impact of malnutrition on survival in AIDS was evaluated by examining the magnitude of body-cell-mass depletion as a function of time from death. Body cell mass was estimated as total body-potassium content and determined by whole-body counting. There was progressive depletion of body cell mass as patients neared death. The extrapolated and observed values for body cell mass at death were 54% of normal. Body weight had a similar relationship to death, with a projected body weight at death of 66% of ideal. We conclude that death from wasting in AIDS is related to the magnitude of tissue depletion and is independent of the underlying cause of wasting. The degree of wasting seen in this study is similar to historical reports of semistarvation, with or without associated infections. This observation suggests that successful attempts to maintain body mass could prolong survival in patients with AIDS."
Mangili A, Murman DH, Zampini AM, Wanke CA, "Nutrition and HIV infection: review of weight loss and wasting in the era of highly active antiretroviral therapy from the nutrition for healthy living cohort," Clin Infect Dis. 2006 Mar 15;42(6):836-42. Epub 2006 Feb 7.
Nelson Vergel, Program for Wellness Restoration
http://www.gmhc.org/health/treatment/ti/ti21_1.html
The current terrain for wasting patients in the era of HAART On March 20, 2007, Watson Laboratories stopped the production of nandrolone decanoate (old brand name: Deca Durabolin), a low-cost injectable anabolic steroid used for HIV wasting, citing the lack of raw-material suppliers for the product. Patients found out when they went to their pharmacies for a prescription a week later.
Although there are other makers of generic nandrolone internationally (easily located on the Internet), this offers little help to U.S. patients. Anabolic steroids and testosterone are designated by the Drug Enforcement Administration (DEA) of the U.S. Department of Justice as Class III drugs, which are illegal to import even for personal and medical uses.
Over the past 20 years, anabolic steroids have suffered from a lot of bad publicity and misconceptions due to their use in sports and bodybuilding. However, that did not stop activists in the 1990s from convincing doctors and researchers to look into these medicines to help those with HIV-related wasting syndrome. Since then, more than eight studies have been performed that showed nandrolone and oxandrolone (brand name Oxandrin, an oral anabolic steroid) to be effective and safe for increasing lean body mass (LBM) and strength in men and women with HIV. Many physicians quickly learned how to prescribe them and monitor their use for helping their HIV-positive patients to survive what used to be one of the main causes of AIDS mortality.
While Watson was abandoning nandrolone, another company was making a decision that would also limit options for HIV wasting patients. Savient Pharmaceuticals informed patients in April 2007 that it had stopped its 10-year-old patient assistance program (PAP) that gave free Oxandrin (oxandrolone) to HIV patients with no insurance or third-party payment sources. Oxandrin has been shown to be mildly effective in men, women, and children with HIV wasting. It can be taken by mouth daily, while nandrolone must be injected in the butt once a week. Whereas Oxandrin has been approved for the treatment of unintentional weight loss, nandrolone's use for HIV wasting was off-label (it was approved for the treatment of anemia in individuals with kidney problems). However, Oxandrin costs $1,300 a month for a 20 mg/day regimen, compared to around $200 a month for 200 mg/week for nandrolone.
Savient's PAP was set up by BTG Pharmaceuticals (bought out by Savient later on) in 1996 after activists pressured the company to provide the drug for free to those with no access or means. As with nandrolone, only 13 states include Oxandrin in their AIDS Drug Assistance Programs (ADAPs). The termination of Savient's PAP means many patients will have no way to afford this drug. The company informed patients that Watson would sell generic Oxandrin, thus eliminating the need for its PAP. Unfortunately, the generic price for Oxandrin sold by Watson is no different than that for the brand-name product, which will continue to be sold by Savient. Watson will not provide free Oxandrin via a PAP either. This is the first time in AIDS history that a company has stopped a PAP while still selling the drug.
Cost is not the only consideration. Unlike nandrolone, Oxadrin can increase liver enzymes and could be problematic for people with liver disease, or for people taking medications that heavily affect the liver, such as the HIV medication Reyataz, and drugs for those with hepatitis B and C. "The decisions of these two companies have a huge impact on many of my patients' health," says Dr. Richard Loftus, a San Francisco physician with a large HIV practice. "We use nandrolone extensively in patients who have problems gaining weight and who feel fatigued, even with undetectable viral loads. Many of my patients feel better and have experienced no side effects at the doses we use."
In the 1980s researcher Dr. Donald Kotler found that the loss of lean body mass can dramatically decrease survival in HIV-positive people.1 Even though the incidence of wasting syndrome has declined dramatically since protease inhibitors were introduced 10 years ago, many people still need extra help to hang on to their muscle to sustain health and productivity. A study performed at Tufts University School of Medicine reported that as many as 29% of people with HIV in the era of HAART are still losing weight or lean body mass, despite undetectable viral loads.2
Dr. Nathan Sherlock knows first hand about the importance of nandrolone for his health and that of his partner:
"My partner has had a significant problem with wasting due to AIDS and the only way he has been able to stop the dangerous weight loss is to use anabolic steroids. He is also hepatitis B positive. His doctor first prescribed Oxandrin in 1998. Within a couple of weeks he had chemical induced hepatitis with the symptoms of nausea, vomiting, loss of appetite and jaundice. His liver enzymes were all elevated. He stopped Oxandrin and the symptoms promptly resolved. His doctor then prescribed nandrolone 200mg/week and he regained weight back to his norm with no side effects. When he stops taking it the wasting returns so he has been on nandrolone for close to 9 years now...I have been taking nandrolone for wasting due to AIDS for over 10 years. Every time I have stopped taking nandrolone I experience rapid weight loss that can only be reversed by resuming the use of nandrolone."
Al Benson, an HIV treatment advocate in Los Angeles concurs. "Nandrolone is truly 'the Lazarus drug'... it has brought me back from the brink, restored my health and made all the difference in the quality of my life."
Other HIV Wasting drugsThe Food and Drug Administration (FDA) has approved other drugs for the treatment of HIV wasting or appetite loss. Megace (megestrol acetate), a female sex hormone-based product, tends to produce weight gain by increasing fat rather than lean body mass. Adding fat during AIDS wasting has not been shown to improve survival. Megace has also been associated with side effects such as diabetes, blood clots, impotence, and the development of female sex characteristics.
Serostim, a recombinant human growth hormone, requires daily injections and can cause joint aches, swelling, and diabetes. It can cost as much as $6,000 a month, so most insurance companies do not want to pay for it and many ADAPs can't. The kickback scandal Serostim's manufacturer was involved in hasn't helped matters either. FDA-approved appetite stimulants such as Marinol contain THC, the psychoactive ingredient in marijuana. This can be an issue for many people with HIV who are in recovery. It has also been suggested that Marinol may simply owe its ability to increase appetite and weight to a side effect of the THC high — "the munchies."
Compounding Pharmacies:a Viable Option at Risk?Many doctors and patients do not know that nandrolone and oxandrolone can also be obtained in smaller quantities legally by prescription and at a lower cost through compounding pharmacies (where drugs are not only dispensed but can be prepared according to a doctor's specifications). No one knows how much longer this option will remain available. One pharmacy owner reports that the DEA has raided several compounding pharmacies in the past few months, including his own. The Safe Compounding Drug Act of 2007, now under consideration, would place these sites under greater regulation and presumably greater surveillance. In the meantime, compounding pharmacies such as Applied Pharmacy, Kronos, the Compounding Shop, College Pharmacy, and others are still economical sources of nandrolone, oxandrolone, and testosterone gels and injections. However, they do not process insurance claims and are not equipped to supply ADAPs, insurance, Medicaid, or Medicare Part D vendors.
In this era when HIV/AIDS patients are living longer, it is just as critical to fight for safe, effective, and affordable "quality of life" drugs as it to advocate for accessible antiretrovirals. After all we have done as activists to secure antiwasting medications, we must not lose ground now and fall asleep when vital treatments such as nandrolone are dropped without notice and with little regard for patients' needs.
For more information or to find out how to get involved, please visit.
Kotler DP, Tierney AR, Wang J, Pierson RN Jr., "Magnitude of body-cell-mass depletion and the timing of death from wasting in AIDS," Am J Clin Nutr. 1989 Sep; 50(3):444-7. "The impact of malnutrition on survival in AIDS was evaluated by examining the magnitude of body-cell-mass depletion as a function of time from death. Body cell mass was estimated as total body-potassium content and determined by whole-body counting. There was progressive depletion of body cell mass as patients neared death. The extrapolated and observed values for body cell mass at death were 54% of normal. Body weight had a similar relationship to death, with a projected body weight at death of 66% of ideal. We conclude that death from wasting in AIDS is related to the magnitude of tissue depletion and is independent of the underlying cause of wasting. The degree of wasting seen in this study is similar to historical reports of semistarvation, with or without associated infections. This observation suggests that successful attempts to maintain body mass could prolong survival in patients with AIDS."
Mangili A, Murman DH, Zampini AM, Wanke CA, "Nutrition and HIV infection: review of weight loss and wasting in the era of highly active antiretroviral therapy from the nutrition for healthy living cohort," Clin Infect Dis. 2006 Mar 15;42(6):836-42. Epub 2006 Feb 7.
Support PoWeR
Posts
