Alex O'Meara » cancer

Redefining clinical trials out of existence

Alex — Fri, 24 Sep 2010 17:56:04 +0000

I was flying home to Arizona from Charlottesville, VA when I read the story in the New York Times, New Drugs Stir Debate on Rules of Clinical Trials, about a controversy over using a trials drug to treat cancer patients. I had been in Charlottesville for my yearly overnight checkup as part of a clinical trial to cure diabetes. I had received an infusion of islet cells four years earlier and each year I returned to the University of Virginia and they ran more tests than they would on an astronaut. By the time I got on my plane my arms were black and blue, I had not slept in 36 hours, my blood sugar had spiked over 500 as part of the testing and I had nine hours of flying to get through before I could lay down at home.

That’s was partly why when I read in the NYT article that some cancer experts thought a new wave of experimental cancer drugs should be used for treatment before they’re approved I sat stunned. I read the article three times. “Experts” are actually arguing that patients should have increased access to drugs not yet tested and that this should be done on compassionate grounds. This article, by the way, came out a few days before the FDA decided to restrict Avandia, a drug that HAD ALREADY BEEN APPROVED because it increased the likelihood of heart attack

The very first time I saw the words “therapeutic misconception” in the New York Times was just one month ago. In an article by Gina Kolata, What to Tell the Patient After a Trial Goes Awry. “Most patients entering clinical trials believe they are getting a new treatment that may benefit them, Dr. Brody [director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine said]said. Ethicists call that a ‘therapeutic misconception,’ he said, adding, ‘No one should ever assume that in a clinical trial.”

Gosh, ya think?

Like most media outlets, the Times treats trials as another medical option available to patients. This is because patients consider trials a medical option; as if they’re getting to buy wholesale rather than retail. That’s because doctors and researchers encourage patients to think of them as an option so they can recruit subjects to trials. It’s one vast belief but it’s not true. It’s built on statistics: If enough people believe it, eventually it’s true. I used to believe that truth was not statistical, that popularity didn’t make a thing real. And, of course, in an activity as rigorous about process and facts as medical research, truth was surely an inflexible concept. But after reading the NYT article I realized some researchers want the truth to be flexible, based on the whims of doctors and patients. And that’s a great way to make the truth disappear.

Kids and Oncology Trials

Alex — Fri, 14 May 2010 19:13:00 +0000

This is worth reading. It’s about how kids often don’t understand enough about clinical trials and that can impact how many kids take part in trials. This is especially relevant because pediatric oncology trials have long been hailed as an example of the positive power of clinical trials in developing new treatments quickly and safely to such an extent that lives have been saved.

Kids in CA Trials Lack Understanding of Research

By Todd Neale, Staff Writer, MedPage Today
Published: March 29, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

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Among children participating in oncology trials, 41% said they did not know specific purpose of the study, Yoram Unguru, MD, of Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore, and colleagues reported in the April issue of Pediatrics.

Of those who said they did know the purpose of the study, only 22% correctly defined it.

In addition, about half of the children (49%) felt like they had little, very little, or no role in the decision to take part in the trial, despite signing the assent forms.

“Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful,” Unguru and colleagues concluded.

The next step, they said, is developing such a tool.

Most children with cancer are enrolled in clinical trials, and the U.S. Department of Health and Human Services requires that children give their assent whenever possible.

However, previous studies of children’s understanding have mainly involved healthy youngsters using hypothetical scenarios, or they focused on decision-making preferences of adolescents, according to the researchers.

To further explore the issue, Unguru and his colleagues interviewed 37 children and teens ages 7 to 19 (mean 13.6) who were taking part in various oncology trials. The researchers used a novel, 69-item quality-of-assent instrument that the children read as they were asked the questions verbally.

The tool assessed familiarity, knowledge, awareness, understanding, and appreciation.

Only about half of the children remembered being told their treatment was research, even though 87% remembered hearing the word “research” and 95% remembered hearing the word “study” from their doctors.

In general, the children had a poor understanding of the purpose of their respective trials, with 70% saying it was a little or very hard to understand information about the trial when they assented.

The vast majority (86%) said they did not understand the language their doctor used.

Most of the children did not understand the nature of their treatment, with 73% saying they thought research interventions were not more risky than other interventions and that the medications they were receiving were proven to be the best for their condition.

Responding to questions meant to assess the children’s appreciation of the goals of research, 73% said they were participating in the trial to help other children, 60% said they were taking part to get better, and 43% said they were helping doctors expand their knowledge.

All of the children said they wanted to have at least some part in deciding to participate in the trial, while 97% said they wanted their parents involved, and 94% said they wanted their doctors involved.

However, about half felt largely excluded from the decision-making process, and 38% did not feel like they could decline to participate, citing pressure from parents, doctors, or both.

“Our findings suggest that parents/physicians could do more to involve children in decision-making to avoid forcing them to enroll in trials,” the researchers wrote.

They acknowledged some limitations of the study, including the small sample, the possibility that the children’s responses reflected what they thought the researchers wanted to hear, the possibility of bias from recalling past events, and the confusion some children had about the difference between clinical care and clinical research.

The authors reported no conflicts of interest.

Primary source: Pediatrics
Source reference:
Unguru Y, et al “The experiences of children enrolled in pediatric oncology research: implications for assent” Pediatrics 2010; DOI: 10.1542/peds.2008-3429.

Clinical Trials News Update – June 3, 2009

Alex — Wed, 03 Jun 2009 15:44:42 +0000

There is some fascinating and potentially breakthrough news about cancer treatment vaccine trials that was reported in the National Cancer Institute Bulletin. Recent trials could reshape the field of cancer research and the quest for a cure. Whatever is accomplished is no doubt a long way off but it’s worth keeping your eyes on. I’ll continue to keep you informed as this topic develops but here is the lead on a new story…

Treatment vaccines that boost the immune system’s response to tumors may have important clinical benefits for patients with various types of cancer, according to results from several clinical trials presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando.

To many in the field, the findings represent an emergence of sorts for therapeutic cancer vaccines. Treatment vaccines have been the subject of intense study for more than 2 decades, but they have produced little in the way of FDA-approved cancer treatments. That could change based on the recent clinical trial results…

Special Report: Treatment Vaccines for Cancer Perform Well in … National Cancer Institute – NCI Cancer Bulletin – Bethesda, MD, USA – That could change based on the recent clinical trial results. “The field has been getting more attention, and with these recent trials I think we’ll see a … See all stories on this topic

Utah researchers seek clinical trial of stem cell treatment – Salt Lake Tribune – United States – The funding will help support work needed to get permission from the Food and Drug Administration to start human clinical trials at Johns Hopkins. … See all stories on this topic

Featured Clinical Trial: Imaging the Extent of Prostate Cancer – National Cancer Institute – NCI Cancer Bulletin – Bethesda, MD, USA – In this clinical trial, researchers are testing PET scans using a different radiolabeled molecule, carbon-11 (C-11) acetate, in conjunction with subsequent … See all stories on this topic

Clinical Trials Update: June 2, 2009 – U.S. News & World Report – Washington, DC, USA – This study seeks people who have high cholesterol. Participants will receive all study related care and investigational medication at no cost, … See all stories on this topic

New Zealand Herald – New Zealand – She said half a dozen BRAF inhibitors were being prepared for clinical trials but the teams developing them were yet to prove they were safe and effective. – See all stories on this topic

Legislative Action Alert from NORD: Support Expanded Access to … RSDSA – New York, NY, USA – Yet, current rules regarding eligibility for SSI prevent a significant number of people with rare diseases from participating in clinical trials that … See all stories on this topic

New Data from Satraplatin Phase 3 Trial in Second-Line Castrate … WELT ONLINE – Berlin, Germany – Data from other Phase I and Phase II clinical trials evaluating satraplatin in combination with other cancer therapeutic drugs were published in the 2009 … See all stories on this topic

I-SPY trial offers key insights into locally advanced breast cancer – Insciences Organisation – Basel, Switzerland – The goals are to establish a clinical trials model that supports the identification of drugs targeting the molecular profiles of aggressive breast cancers, … See all stories on this topic

Market Report — In Play (CYTK) – MSN Money – USA – In this trial, ispinesib appears to demonstrate anti-cancer activity with a similar toxicity profile when compared with prior clinical trials conducted with … See all stories on this topic

Using trials to treat the uninsured

Alex — Sun, 30 Nov 2008 17:28:33 +0000

A story on CBS News on October 26, 2008 about the “Perils of American Health Care” offers insight into what could be a new and disturbing phenomenon regarding clinical trials taking place because of the bad economy. The story by Rita Braver profiles a woman with a young child. After losing her job and her health insurance the woman found out she had cancer. Unable to find medical treatment anywhere else, she enrolled in a clinical trial that provided her with drugs to fight her cancer.

The story highlights the disturbing manner in which the medical industry itself is increasingly viewing trials as a valid treatment option. Trials are first and foremost about gathering data. While subjects do sometimes benefit medically from trials, trials are never treatment. They are always experimentation. Although with more and more people losing their jobs and their health insurance, the line between treatment and experimentation is becoming more and more blurry for doctors, subjects, and patients in need.