Posts Tagged ‘HIV’

Cancer: HIV/AIDS Patients At Increased Risk

Monday, June 27th, 2011

It is estimated that there are more than a million people in the U.S. infected with HIV.  In 2009 alone, there were roughly 50 thousand new HIV cases. There are approximately 16-18 thousand AIDS-related deaths in the U.S. each year. Although medical advancements have enabled many HIV/AIDS patients to live a relatively normal life, the truth is that the HIV/AIDS epidemic has been and continues to be a public health disaster of astronomic proportions.

As if life with HIV/AIDS is not difficult enough, researchers have also found that HIV/AIDS patients are also more prone to developing various malignancies when compared with the non-infected population. In fact, cancer is one of the leading causes of mortality in the HIV/AIDS  population. It is estimated that 30%-40% of HIV patients will develop some type of cancer during their life time.

The types of cancer that affect HIV patients can be generally divided into two groups: AIDS defining cancers and opportunistic cancers. An HIV positive patient who develops a cancer defined by the Center for Disease Control and Prevention as AIDS defining is considered to have AIDS.  These AIDS defining cancers include: Kaposi’s sarcoma, non-Hodgkin’s lymphoma, and invasive cervical cancer. Other cancers are generally categorized as opportunistic.

Researchers have found that HIV/AIDS patients have a 2-to-3 fold increase in the overall risk of developing opportunistic cancers. Not only are HIV/AIDS patients more likely to develop cancer but the cancer prognosis is worse when compared with that of non-infected patients. HIV/AIDS patients also present with more advanced cancers at the time of diagnosis and, on average, they develop cancers at a younger age.

So, why is the risk for developing cancer higher in the HIV/AIDS population? It remains unclear whether the actual virus has a direct impact on the development of malignancies. It is believed, however, that the increased incidence of cancer is due to the fact that HIV/AIDS patients have a compromised immune system, which can lead to an impaired ability to produce antibodies or inflammatory responses.

Needless to say, if you are an HIV/AIDS patient or you know someone who is, please be aware of the increased risk for developing cancer. Be proactive and pursue proper and timely cancer screening. If you are experiencing unusual symptoms, don’t automatically attribute them to having HIV/AIDS (e.g., unusual fatigue). Unfortunately, they might just be symptoms of cancer.

 

Related posts:

H.I.V. treatment advances, but what are the implications of terminating research early?

 

 

Week in Review (April 16 – 20, 2011) The Eye Opener Health, Law and Medicine Blog

Saturday, May 21st, 2011

From the Editor (Brian Nash)

Another week of great posts (IMHO) by our blawgers. Apparently, I’m not the only one who thinks so since we have now surpassed 21,000 page views in the last 30 days. The number keeps rising. Our sincere gratitude to all our readers!

Our topics were once again quite varied. They spanned the law, health, science and medicine. We even had a piece on a local event – Marathon Kids. This piece is part of our new program to promote charities and civic organizations in our own backyard – Baltimore and Washington.

We try week in and week out to find topics of interest for you, our readers. If you ever have any suggestions for topics of interest to you, please leave a comment or send us an email or fill-out the contact form with your thoughts and suggestions. We’d love to hear from you.

Let’s get to it then. What did we cover this past week that you might be interested in reading? Take a look -

Why early settlement is a win-win for all

By: Michael Sanders

There is an old adage in the law that cases settle on the courthouse steps. There is a reason for that. When the parties are actually walking into court to try their case, they seem to suddenly recognize that there are significant risks to going to trial, and that there is serious money at stake. When you go to trial, only one side can win. The other side goes home a loser. Faced with such a stark outcome, both sides tend to become more reasonable in their assessment of their case and more willing to talk settlement. After all, despite all the years of experience that trial attorneys amass, no one can ever predict what a jury is going to do in any specific case. As one mediator I know likes to tell the litigants, going to court is like going to Vegas:  you roll the dice and you take your chances. Read more….

Milk from Mom: Effective in preventing common infant complication (NEC)

By: Jason Penn

The debate among parents regarding the use of human milk vs. formula wages on, but according to a recent study, you can chalk one up for the human body.  That study, headed by the Johns Hopkins University in Baltimore, concluded that premature babies fed human donor milk were less likely to develop the intestinal condition necrotizing enterocolitis (NEC).  Both sides has its advocates, willing to do battle at any time. When it comes to NEC, Mom’s milk has the decided advantage. Read more….

H.I.V. treatment advances, but what are the implications of terminating research early?

By: Sarah Keogh

Last week, I read some exciting news about H.I.V. treatment and transmission. A New York Times article reported that a large clinical trial found that “[p]eople infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate…” The study found that “[p]atients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs…” These findings are overwhelmingly positive and the implication for public health is huge. Read more….

A Windy, Rainy but Fabulous Day in Baltimore: Marathon Kids Final Mile Celebration

By: Rachel Leyko

Despite the wind and rain, this past Saturday I volunteered at the Marathon Kids Final Mile Celebration Event at Western Polytechnic High School in Northwest Baltimore.  I learned of the event through the Junior League of Baltimore and to be honest, prior to Saturday, I did not know much about the organization, its purpose or effect on the children it sought to serve.  However, after Saturday’s event, not only was I impressed with the purpose of Marathon Kids, but I saw firsthand the positive effect this program has had on the children who have participated. Read more….

Acquired Brain Injuries: Causes and Impact

By: Theresa Neumann

On the heels of Jason Penn’s blogregarding calling “911″ for signs of a possible stroke, I decided to introduce a variety of acquired brain injuries for further discussion in future blogs since damage to the brain results in some of the most catastrophic injuries possibly sustained by the human body with significant “collateral damage” for all of the friends and family involved in the individual’s life. Read more….


Sneak Peak of the Week Ahead

Some topics we’ll be covering next week…and then some…

  • You or someone you know has been diagnosed with cancer, now you have to deal with the horror. Jon Stefanuca will be writing a piece based on our experiences with a number of clients “living with cancer.”
  • Mike Sanders and I have both recently resolved cases involving families who have lost a child. Mike’s involved the death of a fetus very near term. He’ll share that story and the experience of the case with you.
  • Maybe those of you who have children with special needs are familiar with the local (Maryland and Washington, D.C.) resources to help you and your child. For those who may not be or just want to learn more, Jason Penn will be providing information on this next week.
  • You may have heard the recent news about labeling of certain medications for children. Sarah Keogh will report on this and also delve into some practical problems and issues that parents face every day in terms of medicating their children.
  • We’re going to begin a new series on exactly what is recoverable in our jurisdictions (Washington, D.C and Maryland) under what is known as the Survival Act and the Wrongful Death Act. We’ll be paying particular attention to issues involving what’s known as pecuniary benefits, loss wages and diminished earning capacity. Should be educational. We hope you enjoy it.

Have a great weekend, Everyone!

H.I.V. treatment advances, but what are the implications of terminating research early?

Wednesday, May 18th, 2011

Scientific Method; image from: scifiles.larc.nasa.gov

Last week, I read some exciting news about H.I.V. treatment and transmission. A New York Times article reported that a large clinical trial found that “[p]eople infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate…” The study found that “[p]atients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs…” These findings are overwhelmingly positive and the implication for public health is huge.

The study details are fascinating, particularly in regards to the results. For example:

The $73 million trial, known as HPTN 052, involved 1,763 couples in 13 cities on four continents. One member of each couple was infected with H.I.V.; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus.

In the other half, the infected person started treatment only when his or her CD4 count — a measure of the immune system’s strength — dropped below 250 per cubic millimeter.

In 28 of the couples, the uninfected person became infected with the partner’s strain of the virus. Twenty-seven of those 28 infections took place in couples in which the partner who was infected first was not yet getting treatment.

What I found most interesting, however, was that the study was not completed. The reported findings were the preliminary results from the clinical trials. In fact, the article explained that “[t]he data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early.”

The way these results were discovered and released during the course of the study was what intrigued me. Here’s how the study data was described:

“[U]nblinded” to an independent safety review panel, which is standard procedure in clinical trials. When the panel realized how much protection early treatment afforded, it recommended that drug regimens be offered to all participants. Although participants will still be followed, the trial is effectively over because it will no longer be a comparison between two groups on different regimens.

This means that the clinical trial was stopped before reaching completion so that all of the participating couples could receive treatment.

The implications of ending this trial short are complicated. For the participants, the decision can be nothing but positive since it may provide the study participants with the opportunity to receive treatment that could hopefully lead to a dramatically decreased likelihood of infection with a potentially deadly disease. For many others around the world who have a partner with H.I.V., the implications are likewise a boon for public health. The release of these early results may impact treatment of H.I.V. infected individuals around the world who may now be able to protect their partners from infection. However, the end of this study is not as clear-cut in terms of research and ethical implications as it might seem.

I originally became aware of the idea that clinical studies are sometimes cut short in the mid 1990s. My father, an occupational health doctor who died in 1999, was involved in the CARET studies during the 1990s. This large-scale double blind study was looking at whether beta-carotene and retinyl palmitate would be able to prevent lung cancer in heavy smokers and workers who had been exposed to asbestos.  However, the study was ended prematurely based on interim results that suggested an adverse affect on the study participants. Since I was only a high school student at the time that the trial was ended, I did not know many of the details at the time. I understood the basic idea that if a medical research study was causing harm to the participants, that it must be ended. When I read the recent news about the H.I.V. treatment study, it prompted me to try to learn more about how and when clinical studies are interrupted.

There was an article published called “Stopping the active intervention: CARET” that I found enlightening about how and why the CARET studies were ended.  The article provides an overview that I found helpful in thinking about the current H.I.V. study:

The optimal design of a randomized clinical intervention trial, where the outcome is a disease endpoint, includes a set of criteria for stopping the active intervention before planned. These criteria, called “stopping rules,” guide the review of findings by key study scientists and an independent set of reviewers. If the pattern of outcome, effect or harm, is large enough to be attributed to the intervention, the trial is halted, regardless of the planned completion date or the readiness of staff to end the trial.

While in the H.I.V. study, the impact was positive, rather than negative as in the CARET study, the procedure seems to be similar. A procedure in the study allowed for data to be unblinded and examined by an independent panel which then recommended that the trial be stopped early.

However, this does present two potential problems. One is that the study, scientifically speaking, did not reach its full conclusions. It may not provide as much evidence of implications as it might have if it had continued or if the study population had been larger. For example, the New York Times article mentioned the following:

Although the trial was relatively large, there are some limitations on interpreting the data.

More than 90 percent of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual.

“We would have liked to have a substantial number of men as potential study subjects, but they just weren’t interested,” Dr. Cohen said.

Although common sense suggests the results would be similar in the contexts of homosexual sex and sex between people who are not couples, strictly speaking, the results apply only to the type of people studied, Dr. Fauci said.

Another implication is that the results may not be as scientifically accurate if the trials are stopped early.  A study published in JAMA entitled “Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects: Systematic Review and Meta-regression Analysis” explains:

Although randomized controlled trials (RCTs) generally provide credible evidence of treatment effects, multiple problems may emerge when investigators terminate a trial earlier than planned, especially when the decision to terminate the trial is based on the finding of an apparently beneficial treatment effect. Bias may arise because large random fluctuations of the estimated treatment effect can occur, particularly early in the progress of a trial. When investigators stop a trial based on an apparently beneficial treatment effect, their results may therefore provide misleading estimates of the benefit. Statistical modeling suggests that RCTs stopped early for benefit (truncated RCTs) will systematically overestimate treatment effects, and empirical data demonstrate that truncated RCTs often show implausibly large treatment effects.

(internal footnotes omitted)

So, perhaps, if the trial were continued, the results would not have been as overwhelmingly positive. Perhaps the percentage of partners infected in the two groups would not have been as widely divergent. But perhaps they would – and would you want to gamble with someone’s life?

Have you ever been involved in a clinical research study that has been ended early? Was it for positive or negative results? What should be done to maximize public health and safety while still providing the benefits of full blind research studies?