Oncotype Score (29) and Chemo, Talk with me?

avidreader · April 2017

Hi everyone,

I am 33 years old, with no family history of breast cancer (limited cancer history in my extended family, nothing in my immediate family).

I had surgery a few weeks ago. I had a 4 cm IDC tumor (ER+PR+HER2-). Two nodes were removed, with one node containing .2mm of isolated tumor cells, but the oncologist and surgeon said this isn't important and is still node negative. There were signs of lymph-vascular invasion, and when I asked the oncologist to clarify if this was simply because of lymph node connection, she said, no, the tumor itself showed signs of vascular invasion. The grade of the tumor is 2, scoring 3 for glandular/tubular differentiation, 3 for nuclear pleomorphism, and 1 for mitotic rate.

The surgeon and oncologist both said this still means the nodes are negative. From the beginning, the doctors have told me my cancer "lazy".

I received my oncotype score back and it's a 29. The doctors seem to be even more baffled by this high number than I am. When I asked the nurse navigator about the score, she told me again that this is a "low grade" cancer, but the risk of possible recurrence is just higher in the next ten years.

I feel like I've been told one thing (this is lazy, no big deal), but the details don't seem so "clear cut" for lazy/no-big-deal or is it? I'll admit to not understanding everything about this. It seems strange to me that the 2 of the 3 grading scales were three, but the mitotic rate was a 1. I had a low Ki67 number, too, though.

So... I don't really know why I'm posting on here, other than to vent and talk through this, I guess. I have a second opinion scheduled early next week, but I can't imagine any oncologist will say to go ahead and skip chemo.

I've Googled, but I can't find a list of "factors" that go into the Oncotype score. Would the score be high just because of my age? I think, from my research, that while age plays a bit of a factor, it's not that much. It mostly has to do with the real makeup of the tumor. I just feel like everyone saw my cancer as unremarkable, but now I have this high score and it doesn't mix with the perception of "lazy". How can a no-big-deal tumor have such a high recurrence score? Has anyone on here not done chemo with a intermediate-high score?

Thanks for reading my rambling

farmerlucy · April 2017

I found this a while back. Can't vouch for its validity.

http://meta-x.com/advancesbioinformatics/Rick_Baeh...

Also found this

http://www.stjames.ie/GPsHealthcareProfessionals/C...

They look very similar. Good luck and so sorry you have to deal with all this.

Hopfull2 · April 2017

hi avidreader, my journey is similar to yours. I had surgery then was staged at stage 1a. All docs said no chemo but they were just waiting for my oncotest to come back to pretty much gave it in writing that I didn't need chemo. I was even starting the process to start on my reconstruction. I had already met Up with my PS. Then I get the dreaded phone call by my MO saying he got the test results back and a high score of 38. I was devastated. So chemo it was. I even had to cancel my trip to New York because I had to start asap. I'm 10 weeks PFC and it's not fun by any means but it was doable for me. I was still able to care for my 2young children.i just wanted to make sure that I did everything I can possibly do to not have a reoccurrence. I did not work while on chemo but many woman do. Good luck with everything and sorry about your result.

BarredOwl · April 2017

Hi avidreader:

Re: "The grade of the tumor is 2, scoring 3 for glandular/tubular differentiation, 3 for nuclear pleomorphism, and 1 for mitotic rate."

Versus

Re: "When I asked the nurse navigator about the score, she told me again that this is a "low grade" cancer . . ."

Per your post, the overall grade was "Grade 2", which is by definition intermediate grade. Accordingly, the nurse navigator is not correct or may have misspoken when she stated it is "low grade."

This page from Johns Hopkins explains histologic grade "Nottingham Histologic Score ("Elston Grade")":

http://pathology.jhu.edu/breast/grade.php

Re: "It seems strange to me that the 2 of the 3 grading scales were three, but the mitotic rate was a 1."

As you can see, from the link, three features are individually assessed using specific criteria and assigned a score from 1 to 3, which are then added together. The criteria are relatively independent, so it is possible to receive a high sub-score (3) in some and low sub-score (1) in others.

BarredOwl

BarredOwl · April 2017

The OncotypeDX test for invasive disease is a "gene expression profiling" ("GEP") test. Molecular biology techniques (quantitative "RT-PCR") are used to determine the mRNA levels of 16 cancer-related genes and 5 reference or control genes from a sample of the tumor.

DNA ==> mRNA ==> Protein

If you recall from biology class, genes are made from DNA. In the nucleus of the cell, mRNA "copies" of actively expressed genes are made by the process of transcription. The mRNA is then exported from the nucleus into the cytoplasm, where it is used by the translational machinery of the cell to direct the synthesis of the encoded protein.

The level of a particular mRNA reflects in part the production of that mRNA by transcription, and is thus a reflection of the level of gene expression, which may be high or low. A test that evaluates the gene expression from multiple genes is a "gene expression profiling" test.

The levels of the mRNAs are used to calculate a Recurrence Score, using a mathematical algorithm that accords various weights to the different test genes. Regarding how the test works, here is a peer-reviewed publication from the scientific medical literature with some background:

Sparano and Paik (2008): "Development of the 21-Gene Assay and Its Application in Clinical Practice and Clinical Trials"

http://ascopubs.org/doi/pdf/10.1200/JCO.2007.15.1068

Figure 1 shows the test genes (blue boxes) and control or "Reference" genes (gray box), plus some information about the weight accorded to different genes tested and the Standard Risk categories:

As explained in the accompanying text, in general, "[h]igher expression levels of "favorable" genes (estrogen receptor [ER] group, GSTM1, BAG1) results in a lower RS (because of a negative coefficient in the RS algorithm), whereas higher expression of "unfavorable" genes (proliferation group, human epidermal growth factor [HER]-2 group, invasion group, and CD68) contribute to a higher RS (because of a positive coefficient in the RS algorithm)."

It is important to keep in mind that immunohistochemistry (IHC) methods used by pathologists for ER, PR, HER2, and KI67 testing detect protein not mRNA, while Oncotype entails a quantitative determination of mRNA levels.

BarredOwl

Butterfly1234 · April 2017

Hi All - I have exactly the same Grade 2 with a mitotic of 1. I will try to find the research I read where there is greater emphasis placed on mitotic rate vs the other two markers since mitotic measures rate of cell growth. Mitotic rate can be as predictive as the grading system.So 3+3+1 = 7 which is considered Grade 2. It would be interesting to see if low Ki-67 correlates with low mitotic rate. Mine does. My overactive brain has more questions than answers.

BarredOwl · April 2017

Hi avidreader:

Be sure to obtain copies of your pathology reports from all biopsies and surgeries and your Oncotype report, for your review and records.

The perception that your tumor was "lazy" is probably based on the node-negative status (with isolated tumor cells) in the presence of a relatively large "4 cm IDC tumor", along with low mitotic count and "low" Ki-67. The Oncotype Recurrence Score provides additional insight into tumor biology (as reflected in gene expression profile) and potential for recurrence.

The point of running the Oncotype test is that the multigene Recurrence Score cannot necessarily be predicted from a few standard pathologic criteria. Figure 2 of this paper shows that while there are trends, neither grade nor Ki-67 dictates Recurrence Score.

Gluz (2016)(WGS Plan B translational study): http://ascopubs.org/doi/pdf/10.1200/JCO.2015.63.5383

In addition, there are limitations in the determination of histologic grade and of Ki-67 protein levels, both of which suffer from interobserver variability. In the WGS study, grade was assessed by local pathologists and by a central pathology review (by two pathologists), and the level of agreement was not very high: "Histologic grade was discordant between central and local laboratories in 44%."

For more information on issues with Ki-67 protein determinations, see this post:

https://community.breastcancer.org/forum/5/topics/854271?page=1#post_4948750

Lastly, for your information only, I note that 0.2 mm is one of the cut-offs used to define "isolated tumor cells" (versus "micrometastasis").

AJCC Staging Summary (7th Edition): https://cancerstaging.org/references-tools/quickreferences/Documents/BreastMedium.pdf

"pN0 No regional lymph node metastasis identified histologically"

Note: Isolated tumor cell clusters (ITC) are defined as small clusters of cells not greater than 0.2 mm, or single tumor cells, or a cluster of fewer than 200 cells in a single histologic cross-section. ITCs may be detected by routine histology or by immunohistochemical (IHC) methods. Nodes containing only ITCs are excluded from the total positive node count for purposes of N classi cation but should be included in the total number of nodes evaluated."

"pN1mi Micrometastases (greater than 0.2 mm and/or more than 200 cells, but none greater than 2.0 mm)"

In your second opinion, do not hesitate to ask questions or to request an explanation for the basis for any recommendation.

Best,

BarredOwl

avidreader · April 2017

farmerlucy -- Thank you for the links. I'd stumbled upon one of them, but the other was new to me. Both are helpful.

Hopful2 -- It's so nice to hear about someone with a similar path as mine, and that you're young with kids, too and that you can say it was all "doable". Logically, I understand that none of this experience is ideal, but I just want to believe that it's all manageable, and it'll be fine. Your score was much higher than mine, which was probably very surprising. I think chemo will be doable; I just have to learn what I can let go of in my semi-overwhelming regular life. It'll all work out, whatever the path ahead looks like.

BarredOwl -- I secretly hoped you'd comment here. I was surprised by the nurse navigator calling it "low grade" because I know that a grade 2 is not a grade; I feel like I'm continuously being told, essentially, that this is no small potatoes. I guess, in the scheme of cancer, it is small potatoes, though.

I think in my early research I'd seen the screenshot you shared, showing how things are factored together. While I'm obviously not a doctor, it's helpful for me to have an idea of what goes into everything. The more information I have, the better I'll feel about whatever choices I make, I guess.

I did get copies of my pathology reports from each step, and I have a copy of my Oncotype report. Interestingly, my Oncotype report is wrong, though, because it says it's for patients with 1-3 nodes positive, and, as I mentioned, the doctors are considering me negative. I had to call to ask what happened, and the Oncotype people are sending the corrected report over, hopefully, this week. Of course, my RS stays the same at a 29.

The oncologist believed my tumor was lazy because I found a bump at the end of November, and when it was biopsied in February, there was no tumor cells in the node. Even though it had grown from the size of a small olive in December, when I asked my husband to feel it, to about 2 centimeters by my tape measuring to even larger just before surgery, the doctors believed all this "growth" I thought I felt was just inflammation. The surgeon was surprised that so much of what she had to remove was really tumor, and the oncologist is surprised at the recurrence score. I want to feel like less of a surprise, and more of a "We know what to do." I don't know if that exists, though.

I brought the .2 mm isolated tumor cells last week, and she said they still consider it negative because it's not over .2 mm. I'm at the cut off, it seems, so we'll just keep it at negative. Maybe this is another "subjective" take on things.

Thank you so much for your wealth of information. You are a great resource for so many of us on this board.

Butterfly1234 -- The oncologist I saw last week said that some places aren't doing the ki67 score because it's unreliable due to subjectivity, but it seems like nearly everything about this testing/suggestions for treatment is "subjective". (I read a study/article like BarredOwl's report about the subjectivity in pathology, which confirmed my idea that so much of this is subjective). I naively went into this experience believing that a path would be set, and I'd just have to check things off, like a to-do list. It feel like everyone is just giving best guesses, and hoping for the best results.

momand2kids · May 2017

Hi Avid,

One of my favorite quotes from my onc " this work is more art than science". by that she meant, they are often trying hard to understand something that is not always understandable. I had a "lazy"tumor-- slow growing--they thought it may have been there 8 years before it was palpable (never picked up on a mammogram). Anyway, oncotype came back at 27 (I think) which was a surprise to me and onc. Intermediate-- could go either way..... no nodes, no vascular invasion--pretty straightforward. I went with the quickest chemo (4 rounds over 8 weeks). My kids were young, I work full time--I needed to get on with it.

You have to do what works for you- and know that you will ultimately make the decision and live with it. I think stage 2 grade 2 is hard-- because the road is not clear--- and you have to depend on the data you have and your gut instinct. My onc and surgeon both agreed with my chemo decision, but did not tell me to do it. They waited until I decided... but I did ask both of them what they would say to me if i was their sister.......

Best of luck.

BarredOwl · May 2017

Hi avidreader:

I have no idea whether a person with a 0.2 mm nodal deposit should receive a "node-negative" or "node-positive" report. As explained below, this may be a different question from the actual pN status under current AJCC criteria (7th edition).

If it is material to your decision-making (i.e., if your medical oncologists might make a different recommendation (ask them) or if you might decide differently re chemo based on receiving a "node-negative" versus a "node-positive" report), please consider further discussion of the question of the proper form of report in your specific case with your teams.

You may wish to discuss the question of the "0.2 mm nodal deposit" and the proper Oncotype report with your current medical oncologist and with your second opinion medical oncologist. If there is any question, perhaps one of them or their pathology associate could inquire with with Genomic Health to ensure the proper report is used "for a person with a 0.2 mm deposit."

You may also consider requesting a second opinion pathology review of actual pathology slides, especially those for the lymph nodes, at the second opinion institution to confirm lymph node status and related measurements, because the 0.2 mm is on the threshold.

The Oncotype Requisition Form:

There is some ambiguity introduced by the Requisition Form provided by Genomic Health found here:

http://breast-cancer.oncotypedx.com/en-US/Professional-Invasive/Ordering/InstructionsGuidelines

Near the top (left) of the Oncotype Requisition Form, the notation under Micromets says: "pN1mi (0.2 -2.0mm)"

Please point this out to your team. Why does Genomic Health appear to include 0.2 mm nodal deposit in pN1mi? Is this an error or is it intentional (for example, based on the patients included in the clinical validation studies (see below))?

The pN1mi definition on the Requisition Form seems inconsistent with the AJCC 7th Edition summary (cited in the post above). But, I do not have access to the actual staging manual.

In addition, the 7th edition of the AJCC Staging Manual was issued around 2009-2010. However, the various AJCC staging definitions have not necessarily been constant over time. As noted by one article:

"Also, there are differences in terminology in literature. Prior to AJCC 2003 and 2006, the term "isolated tumor cells" and "micrometastasis" were not clearly defined."

This might be relevant, because the clinical validation studies featured in the "node-negative" (Paik (2004); Paik (2006)) and "node-positive" (Albain (2010)) Oncotype reports ran the test on old stored tissue samples from patients who participated in much older "base" trials, and who MAY have been staged using the staging criteria from way back when (whatever they were).

Graph 1 of "node-negative" report: The "base" trial was NSABP B-14, which included "node-negative" patients randomly assigned to receive placebo or tamoxifen between January 4, 1982, and January 25, 1988, and some additional "node-negative" patients, all treated with tamoxifen, between January 26, 1988, and October 17, 1988.

Graph 2 of "node-negative" report: The "base" trial was NSABP B-20, in which "node-negative" patients were randomized "[b]etween October 17, 1988, and March 5, 1993".

Graph of "node-positive" (N1-3) report: The "base" trial was SWOG-8814, a trial in which "[p]ostmenopausal women (defined in the protocol by use of standard National Cancer Institute criteria across all intergroup trials) with pathological stage T1–3, N1–2 (1988 criteria;[Ref. 21] excluding clinical N2) infiltrating adenocarcinoma of the breast were eligible . . " Reference 21 is said to be the Fifth Edition (1988) of the AJCC staging manual ("American Joint Commission on Cancer (AJCC). Staging manual, 5th edn. Philadelphia, PA: Lippincott Raven, 1988.) What did the 5th edition provide regarding isolated tumor cells?

SWOG-8814 Base Trial: http://thelancet.com/pdfs/journals/lancet/PIIS0140-6736(09)61523-3.pdf

What type of report should a person with an exactly 0.2 mm nodal deposit receive? Would such patients have been included in the "node-negative" or "node-positive" cohorts in the above "base" trials (and the later related Oncotype test studies)?

At the end of the day, it is possible that even if patients like you were included in certain base trials, there were not very many of them, and your oncologist may have an opinion about which validation studies (and related Oncotype report) speaks more to your situation.

BarredOwl

UPDATE (May 15, 2017):

Genomic Health has now revised their website extensively. Here is a link to the current ordering information:

http://www.oncotypeiq.com/en-US/breast-cancer/healthcare-professionals/oncotype-dx-breast-recurrence-score/how-to-order-a-test

There is also a new example a paper Requisition Form for the test. Please note that the size of "micromets" for the purposes of the invasive test has now been been revised to read "Micromets pNmi (0.2 -2.0 mm)":

Knitpig · May 2017

Hello Avidreader, I do not believe age is a factor in your Oncotype score. The oncotype analyzes the genetic components of your tumor.

I am 33 and had a low oncotype so they decided I wouldn't benefit from chemo. I'm doing Tamoxifen and OS+AI later. Your age may factor in to your oncologists approach to treating you and how often you need to follow up with them.

avidreader · May 2017

Knitpig -- Thank you for commenting. Two weeks ago, I was wishful-thinking about the oncotype score "just" being high because of my age, and not really because of the genetic make up of the tumor. I talked with two different MOs, read the comments here, and read about the Oncotype score in general. While I understood that the genetic make up was tested, I still wanted to somehow shrug off the score. 10ish days later, though, and I'm ok with the process.

It's been such a roller coaster ride. The in-control-of-everything part of me struggles with the very "We don't know till we know" part of breast cancer, so this will be good for personal growth - haha.

Meow13 · May 2017

avid, I was 53 at dx, grade 2 mitotic score 1, 1cm ilc and 1cm idc no node involvement er positive pr negative her2 negative but oncodx was 34. I chose no chemo but took AI drugs 5.5 years NED and counting.

Moderators · May 2017

By the way, in case anyone is interested in participating:

Interview Opportunity: Foundation Medicine, a leader in biomarker testing, is seeking to better understand the patient experience and perceptions of biomarker testing (also referred to as molecular, tumor, or genomic testing). If you have had biomarker (genomic) testing, and live in the USA, they'd welcome the opportunity to speak with you. In appreciation of your time and for sharing your perspectives, they'll provide you with a $50 Amazon gift card. If you fit the criteria, and are interested, please email tamar.sekayan@rx4good.com. They will schedule time for a phone conversation that should last approximately 45 minutes to 1 hour.

BarredOwl · May 2017

To my layperson's knowledge, Foundation One's current tests are not used to inform the question of whether to add chemotherapy to endocrine therapy in patients with early stage breast cancer, which is the subject of this thread.

http://foundationone.com/index.php

There are already a number of clinical trial publications that investigated the patient experience and perceptions of biomarker testing. If this is not a clinical trial or formal study, but simply an attempt to connect directly with patients ("Interview Opportunity"), I would have some concern that it could be a thinly-veiled attempt to promote their tests directly to patients who may lack familiarity with the current clinical use of such tests or the scope of clinical validation.

The commercial provider is not an unbiased source of information. So, rather than contact the commercial provider in the first instance, if patients have any interest in Foundation One testing or other types of tests, I would recommend that they first inquire about it with their Medical Oncologist, who has a duty of care to the patient and is familiar with the specific facts of their case.

BarredOwl

Lisey · May 2017

Barred,

I think this is a survey for people already tested and they are just trying to understand their market and messaging approach. I've emailed them and offered to be interviewed, we'll see what happens.

Cowgirl13 · May 2017

Barred, excellent post. Valuable information.

BarredOwl · May 2017

Hi Lisey:

Perhaps, but they could obtain a lot of information about experience and perception by interviewing existing or former customers. There is obviously much less concern in your case with no pending treatment decisions

BarredOwl

Lisey · May 2017

As an FYI, they've scheduled to talk to me tomorrow. (wow.. that was a fast response). I'll return and report with what type of survey this is.

BarredOwl · May 2017

Hi Lisey:

I googled the email address and found this information. This contact person appears to be an outside contractor and her organization appear to provide consulting services to healthcare organizations in various areas. Other clients include for example, Pfizer, Sanofi, Amgen, AstraZeneca.

http://rx4good.com/team/tamar-sekayan/

Services are described here:

http://rx4good.com/services/

'Big picture thinking starts with capturing critical patient insights that reveal opportunities for engagement throughout the drug development and marketing process – from clinical trial design through FDA approval and beyond. We assess the critical questions, frame the research goals and devise the right methodology to deliver optimal learnings."

Ad boards
Ethnographic Research
Focus groups
One-on-one interviews
Patient Diaries
Survey research
Social monitoring
Videography

Perhaps I am mistaken, but it seems probable that the underlying purpose or use of the information from these "interviews" to assess "experience" and "perception" is commercial and/or marketing-oriented in nature, and if so, I don't support the use of this Community for such ends (albeit for compensation to the interviewee). I am dismayed to see the solicitation has now been posted Community-wide in the Announcements section above "All Topics".

I will be interested in your impressions.

BarredOwl

Lisey · May 2017

Barred, I had the interview and they were very respectful and just wanted to hear my story. I think the main gist is for newbies and how to better educate them on the purpose of these types of tests. I actually said women like you were the reason I even knew about the Mammaprint... These forums are where I learned 90% of everything I know about my breast cancer. I didn't feel it was salesy at all and just aiming for better education. I'm a huge advocate of these types of tests and if this new company can take the best of the Mammaprint and the best of the Oncotype and merge them... it will become the standard imo.

ChiSandy · May 2017

Better that the pharma industry conduct focus groups and patient interviews than waste billions of dollars on overly long direct-to-lay-consumer TV commercials for expensive brand-name drugs that most insurance companies probably wouldn’t cover, exhorting people to nag their doctors about drugs they may not need to treat problems that they might not have. Maybe this is an explanation of why drugs are so much more expensive in the U.S. (and many available OTC abroad). In all my trips to Europe (and two to Asia) I can’t recall seeing a single drug commercial.

BarredOwl · May 2017

Hi Lisey:

Thank you for the update. If they only asked about your personal experience, and did not mention or discuss their specific tests, then I would also feel more comfortable. As I noted above, I would have less concern in cases such as yours, with a finalized treatment plan and no pending treatment decisions.

By the way, in my understanding, the FoundationOne test is not used to decide whether to add chemotherapy. It is used for a different purpose, and does not provide the type of information provided by Oncotype or MammaPrint.

BarredOwl

[Actually, not edited. Post reads as original]

Moderators · May 2017

We appreciate the thoughtful discussion happening around the recent request to interview community members who have previously received biomarker testing from Foundation Medicine. Our evaluation of the opportunity with Foundation Medicine assured us that they are not attempting to market to you or sell you their test. Rather Foundation Medicine is looking to gather insights and feedback from patients to better understand the perceptions of their biomarker testing.

We promise you Breastcancer.org is committed to thoroughly vetting any request made of our Community members. We strive to increase the dialogue between patients, advocates and companies, and considered this to be an opportunity to do that. As always, we welcome your insights and concerns.

Lisey · May 2017

I can vouch that I have absolutely no idea what FoundationOne is even testing... Thus my telling them if they can take the best of both tests and merge them, they'd be the best test out there... They didn't mention what they are testing at all, so I'm assuming and offering marketing suggestions as that is my profession. They were more concerned about ways to help newbies understand biomarker tests in general and not just one test or one company. I'm an outlier though, because I jumped head first into studies and articles with the links listed by BarredOwl and others, so I knew going in to my meeting with the oncologist what I would do and what these tests were about.

BarredOwl · May 2017

Hi ChiSandy:

The reason that you have not seen such advertisements when you travel to Europe and Asia is that it appears that there are only two countries in the world that permit direct-to-consumer advertising of pharmaceuticals: the US and New Zealand. It is clear that reasonable minds may differ, but in this case, the US and NZ appear to be outliers:

Rollins (2016): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4818998/pdf/ijhpm-5-287.pdf

"From an overall perspective, the practice of DTCA [direct-to-consumer advertising] has been postulated to have benefits and risks in and of itself. Through both research and opinion papers, pros and cons for the impact of DTCA in the areas of drug utilization, the physician-patient relationship, consumer knowledge/education, health outcomes, adherence, broad social outcomes, and legal issues have been examined.6 Further, given the practice only exists in the United States and New Zealand, it begs the question as to whether or not it should even exist at all?" [See text for full discussion and conclusions.]

BMJ Editorial (2007): http://www.bmj.com/content/335/7619/526

"The promotion of prescription drugs to the public ("direct to consumer advertising") is currently used only in the United States and New Zealand. A systematic review of the clinical and economic consequences confirmed that this form of advertising influences patient demand and doctors' prescribing behaviour, but evidence of health benefits or improvements in underuse was lacking.[1] A more recent report from the Institute of Medicine confirmed that direct to consumer advertising increases the early use of new drugs and asked for a two year moratorium of such advertising for newly approved drugs.[2] Requests were made to revise the legislation towards limiting or even banning such advertising both in the US and in New Zealand[3,4] after rofecoxib (a heavily advertised drug) was withdrawn from the market because it increased heart attacks.[5]"

The AMA called for a ban on such advertising in 2015:

AMA https://www.ama-assn.org/content/ama-calls-ban-direct-consumer-advertising-prescription-drugs-and-medical-devices

Stat News (2015): https://www.statnews.com/pharmalot/2015/12/08/ama-ban-drug-ads/?s_campaign=trendmd

And a view contra: Stat News (2015): https://www.statnews.com/pharmalot/2015/12/30/drug-ads-drug-pricing-ama/

It seems to me that directly contacting individual patients in the setting of a focus group or in one-on-one interviews may raise some of the same concerns raised by direct-to-consumer advertising. At least TV ads are at arm's length, which is not the case with in-person contact. There are cases in which pharmaceutical companies contacted existing or former patients and caregivers, and gained valuable information from this outreach that led to improvements in products and patient care. So there are clearly pros in gathering information from patients. If properly conducted, the pros may outweigh the cons, but whether any particular effort is appropriate in my mind, depends on facts and context.

This particular situation and the way it was rolled out (either totally without discrimination in the general announcement section above All Topics (as of this time, now removed) or in specific threads started by individual patients with pending decisions) left me feeling "mildly nauseous." This is my personal view, and I acknowledge that others may reasonably have a different view.

My apologies to Avidreader for diverting the discussion.

BarredOwl

[Edited to add: In addition, I do not see this an either-or situation: We need not accept in-person interviews by or on behalf of commercial industry in lieu of DTC advertising or vice versa. If permitted under local laws and regulations, each should stand on its own its merits, both in general and in each specific instance of an ad or in-person contact with patients. In this regard, DTC print and TV ads provide an accurate and complete public record of the entire communication, and are more easily policed by the Office of Prescription Drug Promotion ("OPDP") in FDA, formerly known as 'DDMAC" (FDA's Division of Drug Marketing, Advertising, and Communications).

Moderators · May 2017

And our apologies as well to Avidreader for diverting the discussion. We will be mindful of where we post, and will use the Announcement box moving forward.

farmerlucy · May 2017

Just did the bio marker interview. Quite cathartic to repeat my saga. They certainly did not try to sell me anything. I realize in the six + years I've been at BCO I've acquired quite a knowledge base. Love that.

And the Amazon gift certificate is awesome, too.

Big hugs all around.

BarredOwl · May 2017

Hi Avidreader:

FYI only, some time after my April 30, 2017 post above (when I last accessed a copy of the Requisition Form), Genomic Health has revised their website extensively. Here is a link to the current ordering information:

http://www.oncotypeiq.com/en-US/breast-cancer/healthcare-professionals/oncotype-dx-breast-recurrence-score/how-to-order-a-test

There is also a new example a paper Requisition Form for the test. Please note that the size of "micromets" for the purposes of the invasive test has now been been revised to read "Micromets pNmi (0.2 -2.0 mm)":

BarredOwl

Lisey · May 2017

Farmer Lucy, did you get your card already? I'm still waiting to hear back from them on it.

farmerlucy · May 2017

They said I should hear from them next week about that.

Oncotype Score (29) and Chemo, Talk with me?

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