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AIDS Treatment News
March 20, 1998

Contents:


For subscription, donation and editorial information and to read our Statement of Purpose, visit AIDS Treatment News' page here at The Body.

Future Directions

by John S. James


Many free publications and meetings for medical professionals and/or for patients are funded by an "unrestricted educational grant" from one or more pharmaceutical companies; these grants operate under FDA regulations designed to keep the sponsors from biasing the material. So far AIDS Treatment News has not produced such publications, because of our concern about remaining independent of industry.

We are now considering contributing material already published in this newsletter to a patient-education project funded by such an arrangement. We would maintain complete editorial control, and would not be working for a pharmaceutical company but for an organization funded by several companies. We would receive a small payment and, most importantly, reach thousands of people who otherwise would not know about AIDS Treatment News.

Before deciding whether or not to proceed, we want to hear from interested subscribers and other readers. Would you see this kind of project as a beneficial step in distributing useful information, or as a threat to our independent voice?



Fatigue and HIV

Interview with Lisa Capaldini, M.D.

by John S. James


Lisa Capaldini, M.D., practices medicine in San Francisco and sees many patients with HIV; we interviewed her last August on protease inhibitor side effects. Recently she spoke in San Francisco on HIV-related fatigue. We conducted the following interview after attending that talk and seeing the public interest in the subject.


AIDS Treatment News: What should patients know about different kinds of fatigue -- for example, whether you are generally tired in the morning, or after physical exertion?

Dr. Capaldini: Fatigue is one of those important and tricky body symptoms that can be caused by just one specific disorder, or by several problems working together. Because it is a feeling we all experience once in a while, there is a tendency to view it as a normal part of daily life. And because in HIV disease it tends to come on slowly, fatigue is easy to miss; unlike a high fever which was not there and then is one day, fatigue tends to come on subtly and become worse over time. So it is important for patients with HIV and their doctors to do a fatigue inventory every six months or so, since the problem could be overlooked. And in a large majority of patients, the causes of fatigue can be identified and treated.

One kind of fatigue -- physical fatigue -- shows up after specific activities -- for example, getting unusually short of breath after climbing a hill, or having your legs give out while walking three blocks to the grocery store, or having your arms be too weak to stack soup cans on your kitchen shelf. Abnormal physical fatigue is often due to a specific system of the body malfunctioning -- for example, lung problems, heart problems, nerve problems, or muscle problems.

Psychological fatigue -- which might be called motivational fatigue -- means not having the get-up-and-go to do things because they do not matter as much, they are not worth doing. This has a specific name in Western medicine; we call it anhedonia, meaning that activities do not give pleasure as they used to, so you do not put the energy into doing them. A way to distinguish physical from psychological (or motivational, or spiritual) fatigue, is to notice if you are not doing something because you do not have the physical resources to undertake it, because it is not worth what the activity will take out of you -- vs. not wanting to do it because it is not enjoyable for you any more.

Another way to look at fatigue is when does it bother you. If you regularly wake up tired, and that tiredness persists through the day, that is a strong clue that you may be depressed -- as opposed to waking up feeling pretty good and then getting tired as the day goes on, during specific activities, which is more characteristic of physical fatigue.

Morning fatigue may be a symptom of biochemical depression which is primarily a brain hormone problem, characterized by low levels of serotonin and/or norepinephrine. Sometimes depression symptoms are due to low levels of sex hormones, a condition called hypogonadism. The same symptom can have quite distinct causes.


ATN: In your recent talk you mentioned lack of restorative sleep. Where does that fit in?

Dr. Capaldini: Good sleep is not just an issue of how long are you in bed with your eyes closed and not conscious, but also whether you go through several appropriate cycles during your sleep. In certain serious illnesses, for example cardiac or lung diseases, it has been found that people often do not go into the deepest parts of sleep; so even though they have been in bed for eight hours, they do not wake up having slept normally. A different example is when people are jet lagged; they may be able to sleep, but not feel rested afterwards because their sleep and circadian rhythm cycles are not in synch.

With HIV disease, there are many reasons why people may not have uninterrupted sleep -- for example, getting up to take medicines, diarrhea, having to urinate because of taking lots of fluids with Crixivan, etc. Even if a person is able to fall asleep and stay asleep as far as they can tell, their actual sleep architecture may not be normal. Some investigators have identified a pattern of non-normal sleep in persons with HIV who have no known reason not to sleep normally. That suggests something involving HIV, and/or its treatment, may affect the brain.

Another common cause of not sleeping at all, or poor sleep, is pain. One of the challenges in finding appropriate pain treatment is to find a drug that controls the pain enough to permit good sleep, without causing the person to be so sedated in the morning that it is hard for them to get up and get going.


ATN: What are the most common causes of physical fatigue in persons with HIV?

Dr. Capaldini: Some of the common causes are anemia, chronic diarrhea, chronic pain, chronic respiratory insufficiency from prior pneumonias or new pneumonias, a general lack of energy from malaise due to certain drugs (for example, Norvir, Crixivan, or AZT), and pain due to neuropathy.

But the two causes of fatigue in HIV which I believe are most easy to miss are depression and hypogonadism.

Also remember that fatigue is contextual. If you have a given level of energy and you are trying to commute three hours a day, put in a 40-hour work week, and get your kids to school, etc., that is quite different from being able to wake up and get up when you want to, you do tasks when they are convenient or easy for you. One reason people need to think about disability is not so much that they cannot work, but that given their limited energy, they are putting all their energy into their work tasks and not having any left for day to day activities.

It is very important for people who are either trying to get on disability, or are on disability and may need to maintain that, to make sure their doctors are documenting their limited energy reserves, in case down the line the disability needs to be renewed or is challenged. It is easy to see someone with HIV who looks tanned and fit and think they are doing great; but the reality may be that you are seeing them in their three good hours a day, and then they are going home to have a nap which the average person would not need.


ATN: What about problems in concentration?

Dr. Capaldini: You can divide psychological fatigue into two categories, one being more motivational or spiritual issues of meaning -- it's not worth it, I don't enjoy this any more -- vs. more simple mental fatigue, as if the brain were an organ that just tires more quickly. So tasks of attention, concentration, or calculation which were previously taken for granted are now difficult or unreliable.

The earliest sign of this is usually what I call benign forgetfulness, which basically means that unless you make a point of paying attention to things you may more easily forget them. Often patients are concerned that this may represent early HIV dementia, but I find that more often than not, this is not a symptom of dementia but of fatigue. When a person is challenged in their energy level, one of the ways it will show up is that their attention does not function as well as it normally does. But this is not dementia.


ATN: What are some questions people might ask themselves before they see their doctor?

Dr. Capaldini: One of the ways fatigue is best picked up is to check in with yourself every six months or so, and compare your energy level to six months ago -- and equally importantly, two years ago, and five years ago. If there is a dramatic difference, it would be an indication of fatigue that may have been accommodated to but not recognized.

Are there activities that require physical effort that you used to do routinely that you do not or cannot do -- like carrying the laundry to the laundromat, carrying more than one bag of groceries up the steps, being able to ride a motorcycle, walking your dog? Are you no longer doing the things that you used to make time to do because they were fun for you -- gardening, making dinner for your friends, going out to movies, going to the gym? Are there specific activities that used to be fun that are not fun any more -- the best example for many people being sex? Is your libido gone?

Are there specific problems with your body when it comes to physical activities? Do you get short of breath more easily? Do your muscles tire more easily? Do you get dizzy more easily? And if you notice these things, it is very helpful when you go to your clinician, to say I think I am having problems with my energy, and this is what I'm noticing; that helps the doctor beam in to what area is most appropriate to start evaluating.

Unfortunately many of us in medicine tend to assume that fatigue is (a) a normal part of HIV disease, and (b) a normal part of aging. And while it is clear that fatigue is more common in people with HIV disease, and in people as they get older, that does not mean it is normal; it just means you have to look to find the cause. There are some patients who have fatigue for whom no specific cause will be found, but in my experience that is very much the exception rather than the rule.


ATN: What medical tests are usually run when diagnosing fatigue?

Dr. Capaldini: To some extent this is guided by your HIV status; the more advanced your HIV disease is, the more likely certain problems will occur. But a general list would be:

  • A test called the CBC, primarily to look at your red blood cell count to see if you are anemic;
  • A testosterone level to see if you are hypogonadal. This test is much harder to interpret in women than in men. We do not have a very good way to assess androgen status in women, although I think getting a DHEA level and a testosterone level is a reasonable place to start in a woman.
  • A chemistry panel to look for electrolyte abnormalities, and to check liver and kidney function.
  • Consideration of a chest X-ray and/or pulmonary function test, if breathing seems to be the main problem.
  • Patients who are receiving dapsone therapy should also get a methemoglobin level.
  • There are some other tests worth considering, if the evaluation suggests a specific problem -- for example, a Cortrosyn test for adrenal insufficiency, or if it seems there may be a cardiac problem, a test called an echocardiogram.


Hypogonadism in Men

Dr. Capaldini: Hypogonadism -- low levels of androgens and/or other sex hormones -- can cause a syndrome that is very difficult to distinguish from depression: low sex drive, listlessness, trouble concentrating, depressed mood, etc. So I always check testosterone level in men with HIV disease if I am considering a diagnosis of depression. If it is hypogonadism, you replace the testosterone, with either shots or patches, to see if the symptoms clear up. If so, you know they were due to the low testosterone; if not, then the patient may have biochemical depression.


ATN: What are the different tests for testosterone?

Dr. Capaldini: There is a regular testosterone level, which is your total testosterone; that can be broken down into free and bound testosterone. Free testosterone is what is physiologically active; bound testosterone is available to be used, but not biologically active. Most people with hypogonadism in HIV disease have low-normal total testosterone levels; if you break that down into free and bound, their free testosterone is also low-normal.

The tricky part diagnositically is to recognize that while the testosterone may be technically in the normal range, it may be lower than normal for that individual. For example, the normal range in most labs is 300 to 1100, and is not adjusted for age; but most men in their 30s, for example, have a level around 750. If I test them and their level is 350, that is in the "normal range" but not normal for them. This has been a barrier dealing with managed care, when they ask how can you justify replacing this hormone since it is in the normal range. But all hormone test results have to be interpreted contextually. And if a person who is having trouble with their libido and energy has a "low-normal" level of testosterone, that is not normal for them.

Usually it is straightforward to replace testosterone and to determine if it reverses fatigue. The real choice for patients is deciding which drug delivery system to use, whether patches, pills, or shots. Also note that with testosterone or other androgen replacement, therapy may not work optimally without exercise.

There is also an oral anabolic called oxandrolone, and it is an excellent drug for treatment of weight loss and appetite problems due to hypogonadism. But it typically does not correct the sex drive, mood, and energy problems associated with this condition. So if a person takes oxandrolone, they may also need to take a testosterone-type treatment.


ATN: What are the options for delivering testosterone?

Dr. Capaldini: Testosterone is available different ways. One is by an intramuscular shot; you get a very unphysiologic pattern of rapid peak and fall of blood levels, but it seems to work fine clinically. Some people like the shots because getting one every two weeks fits easily into their routine. But for others the injections are uncomfortable or inconvenient.

A common dose is 400 mg. of testosterone cypionate intramuscularly every two weeks. An alternative injection drug is nandrolone (also known as Deca-Durabolin) 200 mg every two weeks. Some patients and doctors have found that combining them in certain ways can give better results than either drug alone. We need better data on these treatments. If you survey doctors in the San Francisco area who use androgen replacement therapy, you find that we use rather different approaches.

There are two different patch delivery systems for testosterone. One, called Testoderm, is placed on the scrotal skin -- not to be adjacent to the testes, but because that skin is very thin. An advantage of that is that you cannot see the patch, for example if you are wearing a bathing suit. But some men, particularly those who live in humid environments, find it does not stay on very well.

An alternative is Androderm, which is placed on non-hairy regular skin. Both the problem and virtue of this patch is that it sticks very well. Some people find removing the patch to be difficult, and/or they get inflammation at the site. (This is an irritant reaction, not an allergic reaction, and can be treated with topical steroids.)


What about testosterone gel?

Because of the cosmetic or logistical problems with the patches or shots, many people have tried using testosterone through gel or cream formulations, which are designed to deliver a fixed amount of testosterone in a given volume of cream or gel which is applied to the wrist area, or to the skin between the thighs, both of which are relatively thin skin areas. I have found that for some people this works great. But others do not seem to absorb the drug very well; when you measure their testosterone level, they are not able to get levels they had with either injection or patches. I think this is worth a try for people who do not like shots or patches. But you need to find a pharmacy which does what is called "compounding"; there is at least one in San Francisco, and others elsewhere (that can fill prescriptions by mail). But some prescription plans do not pay for compounded drugs (drugs that the pharmacist must prepare, rather than pre-packaged drugs). And these compounded forms of testosterone generally run about $50 to $60 a month.


ATN: What is the expense of testosterone shots, or of patches?

Dr. Capaldini: Testosterone shots are quite inexpensive for the actual drug. The cost is mainly with the doctor visit fee in giving the shot. Sometimes the patient can save money by finding a friend who can give the injection.

The patches cost about $60 a month, and generally are covered by insurance; occasionally the doctor has to provide a letter that says that this is treatment for wasting syndrome or HIV-associated fatigue. Because none of these drugs have been used in trials to look specifically at HIV-associated hypogonadism or HIV-associated fatigue, technically they are not FDA-approved for that specific indication (oxandrolone, like growth hormone, is FDA approved for HIV-associated wasting). That is where you get into hassles with managed care, because by the book they may only have to cover FDA-approved interventions. I have been surprised at how difficult it has been to get certain payers to cover testosterone treatment; Medicare and Medi-Cal are not a problem, but some of the PPOs (preferred provider organizations) are.

But if you are hypogonadal, it is worth the money to treat it. After a month or so of treatment, if you dramatically feel better, it is worth the cost to continue.

The down side of hormone replacement therapy is that many men who take testosterone supplements will get acne, usually on the back or on the face, and some will notice that their testes shrink; if they are interested in having children, there might be fertility concerns in the long run.

It is important to distinguish between physiologic replacement doses of testosterone, and much higher doses used in gyms, that are not replacing what is missing but instead giving the body far above what is normally present. There are serious side effects associated with these large doses -- for example, behavioral problems, liver problems, and cardiovascular disease -- that as best we know are not associated with physiologic replacement doses. Some men will notice feeling a little edgy when they take testosterone replacement; they may be unusually sensitive to the drug, and the dose may need to be reduced. Some patients have worried that they might "go postal" from replacement doses, but that does not happen.


Hypogonadism in Women

Dr. Capaldini: In women with hypogonadism, treatment is quite a bit more difficult than with men, because in replacing androgen drugs in women, you have to be careful not to cause a problem called virilization, a syndrome characterized by facial hair, deepening voice, enlarged clitoral size; these cosmetic-like abnormalities may not fully reverse with stopping the drug. There is a pilot study using nandrolone 100 mg. intramuscularly every two weeks, and preliminarily these investigators have not seen any virilization in women. We need data on women and wasting, and are trying to get women to enroll in wasting studies so that we can learn the best way to replace these hormones in women with HIV. We have extensive background in replacing testosterone in hypogonadal men even before the HIV era, because hypogonadism has been a common disease of younger and particularly older men. But we have very little experience in women. Most of the time when a woman is hypogonadal, that is picked up because she is not menstruating or is unable to get pregnant. We have less experience evaluating hypogonadism in the setting of fatigue.

In women androgen replacement is more complicated, because the predominant hormone in women is estrogen -- yet androgen (testosterone, etc.) levels in women, while they are lower than in men, still have important roles. How to best replace these hormones when they are abnormally low in women, without causing menstrual bleeding or other side effects, is more complex, and we have much less anecdotal experience or information from studies to guide us.


ATN: When women are depressed, when that is a major presenting problem, do you commonly find hypogonadism?

Dr. Capaldini: In my experience, no, unless there is a large or prominent component of decreased libido. Even if there is some hypogonadism, it is not clear how effective drugs like DHEA are in women with HIV. So in treating women who have depressive symptoms, including low libido, I will try to

  1. see if there is a role for antidepressant therapy, and
  2. look at hormone replacement therapy -- with estrogen, perhaps with a little testosterone added.
A formulation called Estratest, consisting of estrogen with a small amount of testosterone, is designed for women; it is unlikely to cause virilization.

You have to be careful giving women estrogen, because if they are still having periods, it may give them abnormal periods; and if they are not having periods, it may lead to abnormal bleeding. Someone familiar with hormone replacement therapy needs to either be the primary physician, or be involved in designing hormone replacement. It is trickier in women than in men.


DHEA

ATN: In men or women, what do you think about DHEA?

Dr. Capaldini: This is an interesting and inadequately studied area. Because of the lack of definitive trials, there is little evidence yet to back up the claims that some have reported for this treatment.

There is also no data yet to suggest it is harmful. But I have concerns about replacing hormones in an open-ended or careless fashion. When you give the body a hormone, you may be turning off the body's normal production of it or related hormones. So the idea that because it is a hormone already in the body, and therefore I can safely take as much as I want because the body makes it, is not true.

DHEA therapy should be studied. Meanwhile I generally do not have a problem with patients taking lower doses of it, say 50 mg per day. When patients start taking 200, 500, or 1,000 mg per day I start to worry that it might have an adverse effect in suppressing normal hormone synthesis.

[Part II of this interview will look at depression, anemia, and several other causes of fatigue in persons with HIV.]



1592 (Abacavir, or New Name Ziagen™)

More Widely Available March 23


On March 12 Glaxo Wellcome announced that its experimental drug abacavir (brand name Ziagen, formerly known as 1592) will become more widely available on March 23. Ziagen has already been provided to about 1,900 patients through a limited expanded access program which the company started last summer.

The main changes are that the program will no longer include restrictive entry criteria (the older program required a CD4 count under 100, viral load at least 30,000, and specific drug failures), nor be restricted to physicians who had conducted clinical trials of the drug. Instead, patients must be "failing or intolerant to standard therapy and, in the judgment of the physician, unable to construct a viable treatment regimen without Ziagen." Physicians will require approval from an IRB (institutional review board) to participate in the program, and this will cause delays in some cases; Glaxo Wellcome has set up a central IRB which should be able to process applications rapidly, but many physicians are required to use their hospital or other local IRB, which may not be meeting soon or may be backed up with other work.

This program is open to patients over 13 years of age. For those 13 or younger, a pediatric program is available.

There are exclusions for pregnant or breastfeeding women, and for patients with certain medical conditions who might not be able to use the drug safely.


Background on Using Abacavir

  • The most important safety issue with abacavir is that patients and physicians must be aware of the risk of a hypersensitivity reaction; if it occurs the drug must be stopped and never taken again. "In approximately three percent of patients receiving Ziagen, a hypersensitivity reaction has been observed, consisting of fever with any one or all of the following: nausea (with or without vomiting), malaise, and possibly an accompanying rash. These symptoms begin from several days to six weeks after initiating therapy and resolve within one to two days following discontinuation of Ziagen. Patients experiencing this reaction must not take Ziagen again. Restarting Ziagen after a hypersensitivity reaction has resulted in cases of a life-threatening, and in one case fatal, reaction."

  • Abacavir (Ziagen) should only be started as part of a combination antiretroviral treatment, including at least one other antiretroviral which the patient has never taken.

  • In is unclear at this time who should be using abacavir. Recent studies have found that this drug is unlikely to greatly reduce viral load in those who have already developed extensive viral resistance to approved nucleoside analogs (ddI, 3TC, AZT, etc.).

Patients who are eligible and likely to enroll in an expanded-access program are those for whom standard treatments have already failed in one way or another. Therefore, for many patients it will be difficult to decide whether it is better to use abacavir now, or to wait until more is known about when and how to use it best.


For More Information

For more information on abacavir and the new expanded access program, patients and physicians can call the Abacavir Coordinating Center, 800-501-4672.



Advertisement

CD4 Increase Despite Protease Inhibitor "Failure" in Swiss Study

by John S. James


A study of the medical records of 98 patients treated for 48 weeks found substantial increases in CD4 count even for those whose viral load never became undetectable. The patients whose treatment was interrupted had a much smaller CD4 benefit. These results add to the suggestions from elsewhere that highly active antiretroviral treatment can provide benefit even if the virus is not completely suppressed (see, for example, Clinical Implications of Virological "Failure": Interview with Steven Deeks, M.D., San Francisco General Hospital, AIDS Treatment News #289, February 20, 1998).

When they started HAART treatment, the 98 patients had a CD4 count baseline averaging about 162 -- and about 66 percent of them did not have complete suppression of their viral load. All had extensive prior treatment with antiretrovirals such as AZT. Eighty two took a protease-inhibitor-containing regimen continuously for the 48 weeks; the other 16 had interruptions in treatment averaging 55 days.

Those whose virus became persistently undetectable had a CD4 increase of 138. Those whose virus only transiently became undetectable had an increase of 132. Those who took therapy continuously despite never achieving undetectable viral load had an average increase of 105.

The 16 patients who interrupted therapy had an average CD4 increase of 57.

This study does not answer the question of whether the still-replicating virus will be able to become more resistant later and fully negate the value of the drugs -- or whether the drug-resistant virus is damaged or less pathogenic in some way, allowing the treatment to be of value indefinitely even if undetectable viral load is not reached or maintained. Clearly long-term data will be needed.

Meanwhile, it would help to have more detailed analyses of CD4 changes which occur at different viral loads, both in patients on treatment and off -- and also data on how detectable viremia tends to progress over time in patients who remain on therapy. Currently, the standard goal of treatment is to achieve undetectable viral load (using the most sensitive test available); the reason for this goal is that any detectable viral load means that the virus is replicating in the presence of the drug, and therefore may become more resistant. But since about half of heavily pretreated patients have been unable to reach undetectable viral load, and yet do appear to be benefiting from the treatment anyway, we need more research on how to manage the therapy in this case.


References

Kaufmann D, Pantaleo G, Sudre P, and Telenti A. CD4-cell count in HIV-1-infected individuals remaining viraemic with highly active antiretroviral therapy (HAART). The Lancet. March 7, 1998; volume 351, pages 723-724.



March 25 Free Telephone Conference

"Choosing the Right HIV Treatment Strategy"


Three AIDS physicians will discuss treatment strategy on a national conference call on March 25 (noon Pacific time, 1 p.m. Mountain, 2 p.m. Central, 3 p.m. Eastern). The doctors are Roy Gulick in New York, Stephen Follansbee in San Francisco, and Mary Romeyn in San Francisco. This call is organized by the San Francisco AIDS Foundation and supported by an educational grant from Roche Laboratories Inc.

The program is free but you must pre-register by calling 800-707-BETA (any time 24 hours a day).

If you cannot participate in the program you can hear a tape later by calling 800-550-9235. A transcript should also be available later at www.sfaf.org/betalive.html.



Women's HIV Treatment Workshop

Oakland, California, March 28


Positive Choices: A Treatment Workshop by and for Women Living with HIV will be held Saturday March 28, 10 a.m. to 3 p.m., at the Oakland YWCA, Julia Morgan Tea Room, 1515 Webster St., Oakland, California. This workshop is free but registration is advised;

    For more information call:
    Community Prescription Service
    800-842-0502
    9 a.m. to 9 p.m. Eastern time
    Monday through Thursday
    9 a.m. to 6 p.m. Friday
    Women who need childcare
    are asked to register by March 25.

This free program is sponsored by ten organizations: Community Prescription Service, WORLD, Kaiser Permanente Oakland Medical Center, Women's AIDS Network, San Francisco Community Clinic Consortium San Francisco AIDS, Foundation, Lyon-Martin Women's Health Services, Project Inform, 14th Street Clinic and Women Alive. It is funded by an unrestricted educational grant from Agouron Pharmaceuticals.



New FDA Commissioner Nomination Soon?

by John S. James


Washington rumors, so far unconfirmed, are that Jane Henny, M.D., may be nominated to become the next commissioner of the U.S. Food and Drug Administration. Dr. Henny, currently at the University of New Mexico, is a cancer researcher who was formerly a deputy commissioner at the FDA. She is largely unknown to the AIDS community.

No matter who is nominated, AIDS activists and organizations need to pay attention to the process of selection and installation of a new commissioner. We need to understand and agree on what our major interests are, be aware of the Senate confirmation process, and build relationships with the new commissioner.

Here are some of the issues we have heard in talking with AIDS activists who are familiar with what is happening in Washington:

  • The new FDA reform law calls for expansion of clinical-trials information services to include all serious or life-threatening diseases -- a change which AIDS organizations strongly support. The AIDS clinical trials information system has worked very well; the concern now is that instead of building on this model, the older cancer model may be chosen instead. It lists only government trials, and in other ways, too, gives less information to patients.

  • The phase IV (post-marketing) clinical trials, which companies agree to do in return for earlier approval, need to be monitored and followed up.

  • The new reform law calls for a fast-track system for early approval of important drugs, based on the current accelerated approval and expanded access mechanisms in AIDS -- a change everyone supports. There will be many details and specifics in setting up this system, and because early access is so important to people with AIDS, our community should be involved when these specifics are decided.

  • The FDA needs to continue pressuring companies to determine pediatric doses for important drugs.

Now is the time to further discover and develop our consensus around these and other FDA issues, so that we can present our concerns effectively at this critical time. Hopefully the AIDS community will continue to have access to the commissioner's office, as it did under former commissioner David Kessler, M.D.



ISSN # 1052-4207

Copyright 1998 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.




  
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