Answers for DCIS are coming

Great news for those confused about Ductal Carcinoma In Situ (DCIS). That includes just about everyone, from doctors and researchers, to patients and their families!

Four new projects and resources are available: COMET logo

  1. A new study called COMET just opened that will look at whether women with low-risk DCIS will do just as well with active monitoring (also called Active Surveillance) as those who choose surgery, radiation and/or hormonal therapy. Watch the video.

    “The aim of this work is not to try and determine what’s ‘better,’ but rather to quantify the tradeoffs associated with these two approaches to DCIS treatment.”
    – Dr. Shelley Hwang, Principal Investigator

  2. A new website for DCIS also opened this week to help the over 50,000 women per year who are diagnosed with DCIS each year in the U.S. Of course, the site is also available for women worldwide.
  3. SHARE is sponsoring a webinar called “DCIS: What You Need to Know” that features
    SHARE DCIS webinaryours truly on March 22 at noon Eastern Time (US). We’ll explain what DCIS is, how to think about it, and what is needed to make rational decisions when faced with a diagnosis.
  4.  A new international research project called “Preventing Unnecessary Breast Cancer Treatment” was recently announced to learn how to find DCIS that will not turn into breast cancer so women won’t have to deal with treatment issues.CRUK DCIS graphic

Together, these projects can tell us how to deal with DCIS, what risk factors may cause approximately 1 in 10 women to develop a later invasive breast cancer, and hopefully, that Active Surveillance works just as well as invasive treatments.

By the way, about 90% of women with DCIS won’t get invasive breast cancer!

If you can’t wait to find out more about DCIS, check out this post or get the DCIS Dilemmas ebook. Stay tuned for more about these projects and other findings about DCIS!

COMET study team

Some members of the COMET Study team

Getting Real about Patients & Clinical Trials

I’ve been asked countless times to write about patients and clinical trials. Guess it’s time to share what I’ve learned, along with other patient advocates, as we work beside researchers in the proverbial trenches. Just so happens that this post coincides with April Fool’s Day – hope that’s not an omen!

Why this series?

This is the first in a series on Patients & Clinical Trials (CT). Why? Because clinical trials are really the only tried & true way we get new diagnostics, treatments, and preventive approaches to people. For all diseases and health conditions.

But the research system isn’t very good at it, even after 70+ years. It’s not for lack of trying – BILLIONs have been spent on tweaking existing structures, but perplexing problems persist.

Heads up on CT activities

Other themes will also emerge, based on over 20 years of changing research and medicine culture (or at least trying to). In the meantime, here are some of my activities in the CT world:

Event Inscription on Sign

Other activities:information-orange-circle_fkMzuUIu_L

  • The California Technology Assessment Forum (CTAF), part of ICER, released their recommendations from the February meeting for new drugs in diabetes and asthma.
  • CTTI just released materials from an expert meeting about the issues surrounding FDA streamlined approvals for new antibiotic drug development. A summary will be posted soon. You can also read a past post called Antibiotic Resistance – It’s Complicated!
  • Cures Within Reach focuses on ways that existing drugs can be used for other purposes. More from this group in a guest blog post here soon!
  • Two DCIS studies are being funded by PCORI to help answer treatment questions for this pre-cancer, and learn how women feel about them. You can also read a past post called When is ‘Carcinoma’ Not Cancer?
  • The Center for Medical Technology Policy (CMTP) is working on recommendations to allow patients to switch treatments in a clinical trial if their cancers keep growing.
  • The Metastatic Breast Cancer Alliance (MBCA) is creating a summary of their February meeting from the Research Task Force to Advance Progress.
  • The NC ProCESS project on prostate cancer has convened a patient advisory board to help communicate effectively with prostate survivors in their study.
  • Two groups I’m working with (MRCT and the NCI NCTN Biospecimen Banks) are discussing how to handle the challenges of giving individual research results to patients.

You can also read past CT posts about:

There are many other clinical trial happenings – these are just some of the ones in which I’m involved! Yes, it’s heavy on cancer, but remember that cancers cover the gamut from rare diseases to millions of people.

Updates will be posted regularly. Let me know what you’d like to hear about. TTFN.

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

6 Ways to Turn Data into a Good Read

Ever take a bunch of facts and turn them into something readable? For real people? From many dry scientific journals? When sources disagree? Vehemently?

That is exactly what UCSF researchers Thea Tlsty, PhD, Philippe Gascard, PhD, and I did. Here is what we learned in order to help make sense out of a major worry for women.

But First, Why?

Computer generated 3D photo rendering.

We want to help ~60,000 people (mostly women) who deal with a condition called Ductal Carcinoma In Situ (DCIS) each year. It’s often over-treated, so women want to know what to do. Many questions surround DCIS, and researchers argue at every step along the way.

“DCIS means cells inside the breast duct look and behave like cancer cells. DCIS cells, though, stay inside the ducts and do not travel anywhere else in the body.”

Excerpt From: Deborah E. Collyar. “DCIS Dilemmas

For instance, is DCIS really cancer? Some say no, and want to change its name. Others treat everyone as if they have breast cancer. Still others want to find the 1 out of 10 women (11%) who will eventually get invasive breast cancer so they can be treated, or find the next 11% who might get another DCIS that won’t affect how long they live.

“When you put a frightening term like carcinoma on a lesion that, on average, doesn’t go on to invade normal tissue, that can prompt women who are justifiably frightened of the word cancer to have therapy that’s every bit as aggressive as if they had a true invasive cancer.”

Barry Kramer, Director, Division of Cancer Prevention at the National Cancer Institute in an article from Proto

A few focus on finding almost 8 of 10 women (78%) who will only have DCIS once, and don’t need to endure the long-term problems of over-treatment. Our efforts turned into a new eBook called DCIS Dilemmas: Discussions about Ductal Carcinoma and the Research Behind It. So, how did we do it?

How to group complex data

1. Gather a Range of Data

Research is important, but don’t expect simple answers. We scoured scientific studies (in journals and conferences), and separated conclusions and opinions into different categories. We set a rule that all of the facts we used had to come from at least 2-3 different sources. Articles like this one from HealthNewsReview.org were also helpful.

“New DCIS study, news release lead to (very) mixed messages: ‘And we wonder why patients get confused’”

Dave Mosher in a HealthNewReview.org article

2. Find Out What is Important to Readers

Before starting the eBook, we surveyed 3 groups:

Important Stamp Shows Critical Information Or Documents

  • Women who were cancer-free
  • Women who had DCIS
  • Women who had invasive breast cancer (IBC)

We also held a DCIS Forum in San Francisco to present real information, dispel myths, and hear directly what women want to know.

3. Put It in Perspective

While DCIS is serious, it is not fatal. Unfortunately, many women are led to believe they have breast cancer and are treated this way even though most (over 3 out of 4) will never have another event. The important part is to figure out who is actually at risk for a future invasive breast cancer and what they can do about it.

4. Explain Why Everyone is Confused

Puzzled Confused Lost Signpost Shows Puzzling Problem

DCIS is as confusing to doctors and researchers as it is to patients. A lot of this is due to old ways of thinking, and old terms that are still used. For instance, most doctors and researchers talk about the risk of a “recurrence,” meaning another DCIS or breast cancer. This is actually impossible for DCIS! The old mindset treats DCIS as if it is cancer, not a pre-cancer. It’s time to change that.

5. Explain What Can Be Done About It

It was clear from women that they want to know what to do about DCIS. So, we shared information about:

  • How DCIS is diagnosed ebook DCIS Dilemmas - older woman w tablet
  • The different kinds of treatment used (including Active Surveillance)
  • What risks exist for all women, as well as risks after being diagnosed with DCIS

We also listed current research that will hopefully produce clearer answers in the future.

6. List Resources for All to See

We wanted full disclosure on all of our sources, so we listed everything we reviewed in categories for those who want more information. We also flagged some of the controversies so people can make up their own minds.

What Do You Do?

List your ideas in the comments, so we can learn from each other. We’d also appreciate your feedback on our approach. If you’re interested, check out DCIS Dilemmas: Discussions about Ductal Carcinoma and the Research Behind It and let us know what you think!

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

A Clinical Trial Failed Patients

Something horrible happened – a clinical trial failed, causing one unexpected death and seriously injuring 5 people. And instead of dealing with a dysfunctional research system, “experts” are spouting off on their own. The few articles written to date focus on the drug (aka the money), not on what people want to know.

My Initial Thoughts

high wire climbing in the wood

ClinicalTrialsArena asked me to comment, due to my unique expertise that straddles the patient and research worlds. After researching the topic,* here are my concerns – most of which have not been discussed yet.

This poses a much larger question – why am I the one bringing these up?

Fact 1: Something really bad happened – the first 6 people to get “repeated higher doses” died or were seriously damaged. This is a clear sign of system failure (e.g. approval, protocol, procedures, formulation, PharmcoDynamics).

Fact 2: A phase 1 clinical trial means it is the first time a drug is studied this way in people. 127 people in the trial is far larger than classic phase 1, and most don’t have placebos. Isn’t this more like a phase 2, or the new-fangled phase 1-2 trial? If so, what happened to the rules?

Fact 3: The drug showed activity in laboratory dishes and animals first. We don’t know what mouse-realtesting was done, or for how long. How realistic are the animal models, and how closely do they relate to humans?

Fact 4: Existing articles stress the need for more ‘transparency’ to share the drug’s molecular structure. Patients want honesty first, which in this case may mean, who screwed up?

Fact 5: I’m a big believer (and trail blazer) in presenting trial results, but that’s when we have results. NOT during an ongoing, active clinical trial. Why aren’t we calling for the protocol to be publicly published immediately?

medical_1000006456-120613intFact 6: Healthy volunteers joined this trial after reading an ‘informed consent’ form about its procedures and risks, and they were paid well. Why isn’t the consent form (for every trial) publicly available once the trial is approved?

Fact 7: In the U.S., the Institutional Review Board (IRB) would be shut down and investigated before any new trials could be opened.

Fact 8: A thorough investigation on all parts of this system failure is obvious. This, too, should be open and as public as soon as possible, and at all times.

Fact 9: Risk is an inherent part of clinical trials because risk is part of everyday life. Even when rules are followed, bad things can still happen. Patients aren’t stupid, so there is no need to shut down other clinical trials.

A Setback for Other Clinical Trials?

Amazing we even have to ask this question, right? Of course it will!

Only other researchers may think their trial will be ok because, oh let’s see, because that trial was different – yes, that’s it! That trial (take your pick):

  •  was in a different disease
  •  was in a different country
  •  was run by a company I don’t know
  •  had a different study design
  •  was a horrible accident that would never happen to me
  •  add your own excuse

But patients won’t care about any of that. They’ll steer away from danger or discomfort. And let’s face it, anything called a “clinical trial” isn’t comforting. And as far as whether the rule were (or weren’t) followed – that doesn’t matter either. The rules in the case of a clinical trial include the protocol, of course.

I am firmly in the patient/participant camp. Some may call this a bias, but I consider it the only worthwhile endpoint. I know patients want better answers NOW, and I know people in research deal daily with regulations and hubris.

There was clearly a system failure here, and people needlessly paid too high a price. Let’s find out why and make the pieces work together so people won’t worry about needlessly putting their lives on the line.

* Online information (as of 1/21/16) about the French clinical trial from a Portuguese company is located on Facebook, at #clinicaltrials on Twitter, and is listed in articles from:

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

But, How Do I Get an eBook?

I recently found out I’m not the only one who feels inept about the eBook world. What a relief! The eBook world is exploding, so check it out if you haven’t already.

According to M LeMont,

“Over 70% of Internet users access the Internet via mobile devices instead of a PC” and “Less than 10% of mobile users have a Kindle.”

Confession – I didn’t know how to download eBooks until this year. And I just co-authored one!

If you don’t own an e-reader, you can still download and read eBooks on your smartphone, tablet, computer or web browser. All you need is an app – there are lots to choose from. Here are a few:

So what are you waiting for? Oh, and if you want a trial run, you can always download my eBookDCIS Dilemmas eBook - Press Releasecartoon-smiling-face_7Jwl-z_L

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.