The Cost of Providing Care

Samantha Damren — Thu, 01 Nov 2012 15:17:00 GMT

I was going to write a blog about neuro-syphilis because I just recently treated a 29-year-old patient for this condition, however, on reflection it seems more apt to discuss the enormous financial costs associated with her care. That being said, neuro-syphilis...(read more)

My One Year Anniversary as an NP

Elizabeth Huston — Thu, 25 Oct 2012 13:21:00 GMT

It's ironic that I wrote my last post on October 15, 2012, the 1-year anniversary of my one and only job as an NP. What a year! Or, rather, what a year and a half! The worst of times, yes (the end of a 30-year marriage in June 2011), but also the very...(read more)

Answering Patients' Questions

Samantha Damren — Thu, 20 Sep 2012 12:16:00 GMT

Lately it seems a rash (no pun intended) of patients have asked me how it was that they contracted their Staph infections. Some had MRSA, others MSSA. Some suffered from bacteremia, others osteomyelitis, and others still were challenged by skin/soft tissue...(read more)

Benefits of the Affordable Care Act

Beverly Clayton — Thu, 13 Sep 2012 12:01:00 GMT

"America has spoken" says Nick Cannon from America's Got Talent and the winner is: The American People! This is the feeling of many when the Supreme Court ruled that the Patient Protection and Affordable Care Act (PPACA) is constitutional. Are the American...(read more)

The Weight of the Nation

Samantha Damren — Thu, 30 Aug 2012 12:45:00 GMT

I don't know how many of my fellow NPs and PAs have seen and or heard about HBO's four-part documentary on obesity in America, The Weight of the Nation , but I can't recommend it enough: it is an awesome and totally relevant examination of health in the...(read more)

Losing Purpose

Beverly Clayton — Thu, 31 May 2012 12:01:00 GMT

After reading my fellow colleague Elizabeth's blog I decided to tackle my grief. You see, my best friend and boyfriend of 11 years passed away last month. He was the reason I decided to pursue a career as a nurse practitioner and he was my biggest cheerleader....(read more)

On My Own, In More Ways Than One

Elizabeth Huston — Thu, 03 May 2012 12:06:00 GMT

Seven months out of school and four months into my job, life simply could not be better! The resiliency of the human spirit is amazing, and I never could have guessed that I can feel this level of happiness and contentment after...now I can finally confess...(read more)

Getting Healthy in Prison

Beverly Clayton — Thu, 15 Dec 2011 18:01:00 GMT

In a previous post I compared the behaviors of the clients in the correctional facility to those of someone who did not learn behaviors taught in kindergarten. From one reader, I had a disappointing comment, but that is to be expected. My comment may...(read more)

Combating the Flu

Samantha Damren — Thu, 20 Oct 2011 18:58:00 GMT

As a novice NP I am indebted to my formative nursing training; it has served me in good stead. As the flu season haunts the horizon, I reach back into my arsenal of nursing acquired infection control prevention tactics and disseminate these pearls accordingly....(read more)

Back to Prevention

Samantha Damren — Fri, 09 Sep 2011 13:55:00 GMT

Where does the time go? Like an uninvited houseguest, Fall has arrived. As the month creeps forward, the upcoming school year looms larger on the horizon and thousands of 17- and 18-year-olds prepare to depart for college. Many of the young women I have...(read more)

Fat and the Heart: Reconsidering Conventional Wisdom

Samantha Damren — Thu, 14 Jul 2011 15:55:00 GMT

Calamitous topics of conversation to initiate with strangers include politics, religion and body weight. I multiply that degree of calamity by 100 when the stranger is my patient. So, I carefully avoid the bits about God and Country. However, avoidance...(read more)

Seeing Patients in Corrections

Beverly Clayton — Thu, 07 Jul 2011 14:57:00 GMT

My very first position as an NP is in correctional health. I was excited and very nervous about a role where I would be responsible for so many lives, and furthermore a population of people who desperately need education, education , EDUCATION! The correctional...(read more)

Prostate Cancer Awareness: A Storm Continues to Brew

Melody Davis — Mon, 22 Sep 2008 17:42:00 GMT

For those who know me and those of you who will get to know me through this blog, I am passionate about quite a few things. Topping that list are my children, family, finding a cure for cancer, activism and patient advocacy, to name a few. Therefore, with September being Prostate Cancer Awareness Month, it would only seem fitting to dedicate my first blog to prostate cancer. According to the National Cancer Institute (NCI), in 2007, 218,890 men heard the words, "You have prostate cancer." Of those, 27,050 died from the disease.

Here is my story. My grandfather, who was the only father figure in my life for a very long time, died from prostate cancer. My grandfather was a simple man who lived and made his living off the land. He was a strong and proud family man. In my eyes, he could do no wrong. I thought he hung the moon.

The pride he had before the diagnosis would be the same pride that would ultimately cause him to refuse surgery, chemotherapy and radiation. He was too proud to allow his body to be ravaged by chemotherapy. He said he had lived a good life and believed this was his fate. There is not a day that goes by when I do not wonder: What if my grandfather had been given another treatment option. If he had been given another option, would he have chosen it? Would he still be alive? Would my children have been given the opportunity to know and love their great grandfather, as I had the pleasure of doing?

Growing up in rural Alabama, never in my wildest dream would I have imagined myself an activist. However, life has a way of defining your path in ways you never dreamed. I have organized three rallies to express dissatisfaction in the FDA's approval process, especially as it relates to the drug Provenge.

On March 29, 2007, an FDA advisory panel of immunology experts and other invitees had reviewed Provenge and decided unanimously that it was safe (17-0) and that there was substantial evidence of efficacy (13-4). Unfortunately, the Provenge data were apparently not extensive enough to satisfy the strict "science-driven" statistics of the FDA.

On the surface, statistics and science-driven decisions look noble and positive. However, for dying cancer patients and their families, these words ring hollow. Cancer patients and their families live in a fast-moving, often turbulent, and emotional world, where acting quickly and getting access to the right therapy first can often make all the difference in achieving meaningful survival and quality of life. The average length of clinical trials of a new therapy is now approximately 8 years, from phase one through phase three, literally several lifetimes for terminal cancer patients.

With all the news lately regarding Avandia, Vioxx and the like, one can understand why the FDA would want to err on the side of caution. The caution would be understandable if the debate were not about potential lifesaving and life-extending cancer treatments for late stage patients. Provenge is not another "me too" drug. Herein is where the problem lies.

The FDA has been approving "me too" drugs with serious side effects for chronic illnesses for years. Why the strict statistics approach with potentially lifesaving medicines for dying patients who have run out of conventional options? The debate is not over another headache pill. This is a matter of life or death - a matter of patients and families suffering versus statistics.

Support of Provenge from the medical community is undeniable. Here are a few points of why these health care providers believe Provenge works and that late stage prostate cancer patients should have access (see references at the end of this post). The resistance and hesitation of cancer immunotherapy by some in the medical community may be due to many years of discouraging results with cancer vaccines. However, the Provenge results, mentioned below, are far more encouraging. Provenge has shown activity and efficacy in every one of the six trials where it has been studied including three phase 3 trials (9901, 9902A, P-11).

Researchers Eric Small and Daniel Petrylak present extraordinary survival data for Provenge. They explained the result as a synergistic effect of Provenge combined with Taxotere. Jeffrey Schlom also supports the survival data. The chemotherapy forestalls the faster replicating regulatory arm of the immune system's CD 4 regulatory T cells, while the Provenge boosts the CD8 effector/killer T cells, which not only attack the tumor but also fight metastasis. Survival at 36 months was 34% for the Provenge arm, compared with only 11% for those who received placebo. Median survival was 25.9 months for the Provenge arm, compared with 21.4 months for those who received placebo. Median prostate cancer specific survival was 35.2 months for patients in the Provenge arm, compared with 23.5 months for those who received placebo.

Provenge naysayers are quick to point out that the phase 3 trials failed on their primary endpoint of disease Time to Progression (TTP). TTP improvement came in with a p-value of 0.052 (0.05=successful). True, Provenge did narrowly miss its primary endpoint; however, the immunotherapy community now recognizes that vaccines will result in delayed effect on TTP. Unlike conventional chemotherapy treatments, active vaccines take time to heighten production of the killer T cells.

The FDA's Cancer Vaccine Trial Working Group, which details why TTP should not be calculated from the time of randomization as it penalizes any immunotherapy and would likely have resulted in primary endpoint success if this had been incorporated into the trial design.

Since Provenge is a pacesetter in immunotherapy with trials designed 10 years ago, it only has hindsight as 20/20. The FDA has approved medicines that demonstrated retrospective statistically significant improved survival in a single study even when it failed its primary endpoint. In fact, this was the case with the approval of Carvedilol for congestive heart failure.

Finally, compare the Provenge side effects of mild flu-like symptoms (and a 17-0 advisory committee vote in favor of its strong safety profile) to the only FDA-approved alternative for these patients, Taxotere. Therefore, one can see why there is absolutely no chance of this controversy ending, anytime soon.

To delay benign, promising therapies to patients in this manner won't just cause suffering. The bar is also set that both increases developmental costs for the drugs as well as discourages innovation. The FDA does not have to forego scientific review. The FDA should adhere to the science that already exists and use it to approve and monitor these lifesaving new therapies while patients and their doctors are given informed access to them.

In light of the Provenge decision and others like it, it is imperative the FDA reassess its approval process and approach to immunotherapy treatment for terminal diseases, particularly when no alternative exists and the treatment is safe. If the drug works and it is safe, what would be the harm in allowing the use of these therapies by these patients and their providers who need them now? While Provenge sits on the shelves, 82 American men die each day. Quite possibly, not all of these men would have been saved by approval or access to Provenge, but surely, none of them will be saved by the delay of Provenge.

In memory of my grandfather, David Pickens, CareToLive members John Fish, Richard Ripp, and all the men who have lost their battle with prostate cancer.

Small EJ. Sipuleucel-T for the treatment of Androgen Independent Prostate Cancer. Dendreon. Available at: http://investor.dendreon.com/downloads/22568dndn.pdf

Petrylak D. Defining the optimal role of immunotherapy and chemotherapy: prostate cancer patients who receive Sipuleucel-T followed by Docetaxel have prolonged survival. Mount Sinai School of Medicine CME. Available at: http://www.mssmtv.org/player/player.php?id=111006ada_petrylak

Schlom J, Arlen PM, Gulley JL. Cancer vaccines: Moving beyond current paradigms. Clinical Cancer Research. 2007;13:3776-3782

Buckner CD. Provenge Activated Cellular Immunotherapy, Shows Promise for Treatment of Androgen Independent Prostate Cancer. CancerConsultants.com. Available at: http://professional.cancerconsultants.com/conferencecoverage.aspx?id=3867

Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, Urba W, Blumenstein B, Sacks N, Keilholz U, Nichol G. A clinical development paradigm for cancer vaccines and related biologics. Journal of Immunotherapy. 2007;30(1):1251-1255Moya del Pino B. An update on cancer vaccines - new paradigms. National Cancer Institute. Available at: http://wwwicic.nci.nih.gov/ncicancerbulletin/NCI_Cancer_Bulletin_071007/page6

New Grad NP : Wellness