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-   -   No Travel Required - KRAS-Variant Mutation and Breast Cancer (https://her2support.org/vbulletin/showthread.php?t=62218)

'lizbeth 11-25-2014 09:56 AM

No Travel Required - KRAS-Variant Mutation and Breast Cancer
No Travel Required

A Study of the Inherited KRAS-Variant Mutation and Breast Cancer Risk
Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment (NCT02253251)

Researchers have identified an inherited genetic mutation—a KRAS-variant—that may increase a person's risk of developing breast or other types of cancer. This study will follow participants for 10 years in order to analyze the association between the KRAS-variant mutation and cancer risk. The researchers will also look at the effect that different lifestyle factors have on cancer risk. All participants will have a saliva sample tested for the KRAS-variant. To be eligible, participants must have a personal or family history of breast cancer.

MiraKind, Incorporated
Contact person: Joanne Weidhaas, MDPhD
Phone: 203-671-1308
Email: joanne@mirakind.org
If you speak with this site, please mention that you were referred by BreastCancerTrials.org

Tip: Offer to email or FAX the research coordinator a copy of your Health Summary prior to your first conversation. Use the Print/Save Health Summary feature to print your Health Summary or save it to your computer.

rhondalea 11-25-2014 09:27 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
I'm very unhappy with Joanne Weidhaas.

I participated in the original study (all related correspondence available upon request) for which she recruited through the Army of Women. At the end, she scheduled a webinar to present results, but the Army of Women cancelled it.

The reason the Army of Women cancelled the webinar is the reason for my distress. Joanne sent an advertising email from her "non-profit foundation" to each of the participants offering to sell them their DNA results for the "nominal" fee of $295. This was a violation of the terms of her agreement with the Army of Women, but worse, it really took advantage of the women who freely gave of their time and genetic material.

This was the text of the AoW cancellation notice:

"You may have received an advertisement to purchase your individual KRAS-variant test results from a CLIA certified laboratory from the non-profit group, MiraKind, or a for-profit company, MiraDx. This test was included as part of a research study through the Army of Women®. Our agreement with the researchers who use the Army of Women® specifically precludes them from reaching out to our members separate from the research. We do not know what the results of the KRAS test mean clinically, and at this time this study has not been published, so it has not been subjected to scientific scrutiny. As a result, we have decided to cancel the research webinar scheduled for Wednesday, March 26th 2014."

Speaking as one who has been genotyped and who is currently having her full genome sequenced, there is nothing "nominal" about $295 for those results. I grind my teeth every time I think about that woman.

If you are thinking about participating, at least do a little googling to see what the literature has to say about the KRAS-variant. IMO, she's beating a dead horse and has been for some time.

'lizbeth 11-26-2014 11:16 AM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Yes, I received the same information from Dr. Love's Army of Women.

I was not offended. I welcome all and any new information on my specific cancer.

I do grit my teeth over the numerous requests I get from the Army of Women for money.

The $295 fee was a bit tacky, but there also was an offering of applying for the $295 fee to be covered if you could not afford to pay. I suspected most of us would qualify for it to be paid and I did not bother to apply. The "fee" to me would be more of a non tax deductible donation in the furtherance of cancer research.

Since I have a strong history of family breast cancer I think that I will look into doing the testing. I've already donated my DNA.

There is no such thing as a free lunch. Someone has all your DNA now, and folks will find a way to profit from it.

rhondalea 11-26-2014 11:34 AM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Do read about the KRAS-variant first. She's chasing her tail. She got that patent, and even though the research has not borne out, she won't let go.

My 23andMe DNA genotyping profile is uploaded to openSNP so it's available to all and sundry. When my genome sequencing results are done, they will be publicly available through the Personal Genome Project. I have no concern about my DNA being public, nor do I have a concern about others profiting from its use. I'm involved in several different projects that may well result in profit, including one in which I donated a skin sample for the growth of stem cells. I strongly object to what Joanne did, though. Her study was already funded, and we gave her our time and genetic material. To charge us for the results was...grasping and petty. I'm done with her.

'lizbeth 11-26-2014 11:53 AM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Gosh, and how do you really feel Rhodalea?

So I am curious after the genotyping, did you get the results too? What did you learn?

To be honest, if we could dig into the backgrounds of our researchers - many more of us would likely be offended. This is why I am a fan of being an active participant in our own health and care, something that you do beautifully.

Crap, I am still finding ways to procrastinate on the computer and not getting things going yet.

The exercise is a double edge sword. It will knock you on your ass in the beginning. It took 2 - 3 months to get past the exhaustion afterwards. I was returned to a before cancer level of health after Dr. Joe's work with me. Truly was amazing. I should be exercising today. Blah, must get off computer and go to the kitchen.

'lizbeth 11-26-2014 12:15 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Oh . . . maybe the genome study would be perfect for Linn65?

Can you post under clinical trials more information for others please.

rhondalea 11-26-2014 12:19 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Well, I paid for the genotyping, so I have 900k individual results. That's how I know that Provigil won't work for me and that I shouldn't take Ritalin while I'm taking tamoxifen.

For the same reason, I knew in advance that I don't carry the KRAS-variant, although Joanne claims only her patented test can detect it. I simply don't have the SNP, so it's not an issue even if it were an issue, which it isn't based on the research to date.

I don't care about the backgrounds of the researchers. I do care about the manner in which they conduct their research. I care about their professional ethics. I want to know that they live up to their agreements in the context of their professional lives. What they're doing otherwise is not my business.

Computers are very useful for procrastination. On the other hand, I've been glued to the keyboard for 30 years, so it no longer feels like procrastination to me (even though I know that sometimes it absolutely is exactly that). Today, however, we have snow, so I feel justified in taking a day off and doing lazy things. Still have to clean the litter boxes, though. The cats won't allow me to slack on that.

rhondalea 11-26-2014 01:25 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
I don't think either 23andMe or the Personal Genome Project is appropriate for the purpose, Lizbeth. 23andMe is genotyping, not genome sequencing, so all you get are SNPs. For cancer, that's not especially helpful. Choosing treatments requires sequencing the tumor. I know there has been research using genotyping, but it's limited. Information has been posted before about 23andMe, and I think several people here may be enrolled in the collaboration between 23andMe and Genentech.

The Personal Genome Project...yes, eventually, you'll get a genome sequence, but it will take a long time. I finally had the blood draw last spring, and I don't expect results until...I have no idea when. Depends on funding. I had to drive from New Jersey to Boston to have two vials of blood taken. To put that into perspective, I initially started enrollment prior to being diagnosed with cancer, and I picked it back up after treatment was done. It took almost two years before there was an open blood draw, and I drove 600 miles round trip to have it done. The draws are generally done in Boston or in Mountain View, CA, although they are looking at additional locales. This is something to be done for its own sake, not for urgent medical reasons.

If someone reads this and finds it interesting, they can easily google it, but I wouldn't feel comfortable recommending either to sick people as a tool for addressing illness. Even with the results in hand, you either have to do painstaking research on your own or find someone knowledgeable to interpret your results. Ordering genetic tests through a medical professional is a better bet because you get the specific testing you need, plus interpretation, and it's likely that insurance will pay for it.

'lizbeth 11-26-2014 02:19 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
I have a friend with a rare cancer that did a genome study. She is almost the only one out there being treated for a bile duct cancer at her age. Now I am more curious as she and her doctors gave me the impression that this is more prevalent. Her cancer status is similar to Linn65 as she also has had a recurrence.

I meant the professional backgrounds, not personal backgrounds. You don't like Dr. Weidhaas, I get that. I do appreciate the information. I will read up on it. Still interested in research about breast cancer that runs in families. My family lost at least 2 women to breast cancer and 2 more are dealing with it. I am BRCA negative.

'lizbeth 11-28-2014 04:53 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Oh . . . so this is why the 23andme sounded so familiar - that's right they were the ones on the news that the FDA sent this letter to. I remember now. And wasn't there something else that was reported, let me google some more.


HomeInspections, Compliance, Enforcement, and Criminal InvestigationsCompliance Actions and ActivitiesWarning Letters2013
Compliance Actions and Activities
Warning Letters
23andMe, Inc. 11/22/13

Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration

10903 New Hampshire Avenue
Silver Spring, MD 20993
Nov 22, 2013

Ann Wojcicki
23andMe, Inc.
1390 Shoreline Way
Mountain View, CA 94043

Document Number: GEN1300666
Re: Personal Genome Service (PGS)


Dear Ms. Wojcicki,

The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).

This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.

Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.

Your company submitted 510(k)s for PGS on July 2, 2012 and September 4, 2012, for several of these indications for use. However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter for (b)(4), as required under 21 CFR 807.87(1). Consequently, the 510(k)s are considered withdrawn, see 21 C.F.R. 807.87(1), as we explained in our letters to you on March 12, 2013 and May 21, 2013. To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the Act, 21 U.S.C. § 360(k).

The Office of In Vitro Diagnostics and Radiological Health (OIR) has a long history of working with companies to help them come into compliance with the FD&C Act. Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device. FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Further, we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS. As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.

However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device. The PGS is in class III under section 513(f) of the FD&C Act, 21 U.S.C. 360c(f). Because there is no approved application for premarket approval in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), the PGS is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B). Additionally, the PGS is misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because notice or other information respecting the device was not provided to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific actions you have taken to address all issues noted above. Include documentation of the corrective actions you have taken. If your actions will occur over time, please include a timetable for implementation of those actions. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the actions will be completed. Failure to take adequate corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

We have assigned a unique document number that is cited above. The requested information should reference this document number and should be submitted to:

James L. Woods, WO66-5688
Deputy Director
Patient Safety and Product Quality
Office of In vitro Diagnostics and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993

If you have questions relating to this matter, please feel free to call Courtney Lias, Ph.D. at 301-796-5458, or log onto our web site at www.fda.gov for general information relating to FDA device requirements.

Sincerely yours,
Alberto Gutierrez
Office of In vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health

rhondalea 11-28-2014 05:29 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Oh, and what a nuisance that was.

23andMe got whacked by the FDA for the health reports, so anyone who orders the test after November 2013 only receives the ancestry component. Everyone who had health reports before that, however, kept them. I still have mine. My daughter has hers. The raw data remained unchanged, of course, until 23andMe upgraded to the new chip. My father and my grandson are on the newer platform. Fewer SNPs, but apparently they're more relevant and useful.

So what everyone does now is to use the API to access third-party analysis tools, and some of us continue to do what we always did--research the individual SNPs and clusters of SNPs on our own using information in PubMed and at genome.gov and elsewhere.

23andMe's health reports were pulled from GWAS studies, and they were pretty basic. The FDA's issue wasn't/isn't with the data, because the chip is a standard medical testing device, and the testing itself is done in a CLIA-certified lab. But the health reports hadn't been subjected to the required scrutiny for what the FDA decided to call a medical device (the reports themselves), so Anne got spanked. (Edited to add: Her life was in great disarray before and during this mess--well-publicized husband trouble--so it's not a surprise that she lacked the focus necessary to keep the FDA placated.)

I'm still one of the admins on the FB page for the petition to the FDA asking it to stop being ridiculous. Not sure how I got sucked into that, but the petition eventually got delivered.

I have no idea whether 23andMe is still working on this or if they're satisfied with the way things are. The ancestry component is a big sell, and the company is still able to use the data for medical research even if it cannot provide neat little reports to its customers.

I think the other thing you're looking for is the lawsuit. Some ambulance-chaser in California got the bright idea to have his partner's wife order the test just before the health reports got axed, and then he filed a class-action suit. I haven't checked on the status of that in a while. I do know that most of the active 23andMe'ers sent him nasty emails, and a lot of people opted out in advance. I'm not sure what he hopes to gain. The test costs $99, and 23andMe has a pretty high customer satisfaction rate. Moreover, a good portion of those who take the test are more interested in ancestry than they are in health. I'll be interested to see how it all shakes out.

Edited to add: This is the latest on the class action lawsuit: http://blog.ericgoldman.org/archives...-v-23andme.htm

'lizbeth 11-29-2014 05:29 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Actually I had an email about family tree research is why 23andme is familiar.

Oh, I see, you have a personal interest in the company. Do you have any kind of professional background in genetics?

I do not see how you can compare a company like 23andme to that of professional researchers with a doctorate background from places like Yale, Stanford and UCLA.

I think I'll just contact Dr. Weidhaas and get the real story. Thanks for the information but I put more faith in those that are working directly with cancer research.

rhondalea 11-29-2014 06:39 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
To the extent that I'm a customer of 23andMe, I have a personal interest in the company. If you asked other 23andMe'ers, you might find that many of them feel the same. I don't own stock, though. I'm simply fascinated by the promise of genetics for personalized medicine and what it can tell us about ourselves, and I've done my best to learn as much as I can about it. I signed up for the PGP so I could contribute to the science. I purchased 23andMe because I wanted some instant gratification with respect to my own genes. I had family members tested so I could work on the family tree as a gift to my grandson, because I realized how much of our history had been lost when my grandmother died.

Most of 23andMe's researchers have doctorates from the institutions you mentioned or similar. This is the scientific advisory board:

and this is research team:

As I mentioned, I don't think 23andMe is appropriate for those who are hoping to choose between various cancer treatments, because for that you need to have the tumor itself tested.

I hope Dr. Weidhaas is able to provide you with the information you seek, but 23andMe does test for the KRAS variant (rs61764370). SNPedia has an entry with links to the various articles in PubMed about this SNP.

'lizbeth 11-30-2014 09:29 AM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
I'm still mulling over this - all those impressive backgrounds and they still got stomped by the FDA?

Well perhaps 23andme tests for things - but are they doing specific research to the treatment of my cancer? At least Dr. Weidhaas is researching an area that matches my cancer's characteristics, family history, multifocal, etc. etc.

I will read up on this and look forward to learning more about the research that all these controversial individuals are involved in.

rhondalea 11-30-2014 10:18 AM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Management screwed up, Lizbeth. They didn't keep up with the paperwork, and the FDA got tired of waiting.

I think part of the problem is that in spite of all the disclaimers, some of those who came later interpreted the health reports as diagnoses, which they are not. And of course, doctors started complaining when their patients came in armed with 23andMe results, much as doctors complain when patients bring in Dr. Google results. There were some interesting saves, though, that you can read about on the blog.

23andMe is doing a study with Genentech re Avastin. I think some people in this group are enrolled. They also sell data to other researchers, but I haven't lately looked into who those researchers are. I do try to keep up with the health questionnaires, however, so that my own data is relevant for the purpose of research. (Selling the data is one way that 23andMe is able to a) further research and b) lower the cost of the test to consumers. Everyone who signs up can agree to it or they can opt out. I opted-in.)

Joanne Weidhaas may well be doing other research. I haven't followed her since the Army of Women thing. I just hope it's with something other than the KRAS-variant, because she seems to me to be barking up the wrong tree. It looked promising at first, but it just hasn't panned out. Most of what comes up in first and second page Google results has her name attached, but everything else is other scientists saying "nope, that's not it."

'lizbeth 11-30-2014 12:11 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Oh I clicked on the blog and it seems to have some nice stories about folks connecting to lost loved ones. Anything else I have to get onto other things and don't have time to dig.

rhondalea 11-30-2014 02:40 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
Well, yeah, there are pages and pages of blog posts--including many about breast cancer genetic research--but here's one about someone who dodge a bullet:


'lizbeth 11-30-2014 07:58 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
My husband is homozygous for C282Y and H63D. Very familiar with the phlebotomy treatment of this. I wouldn't exactly call that "dodging a bullet" - but it was nice that she found it early.

Some people that suffer from hereditary hemachromatosis also develop Porphyria Cutanea Tarda due to a deactivation of the uroporphyrinogen decarboxalayse enzyme in the 5th step of the production of heme. This disease is nicknamed the Vampire disease, or the Werewolf disease. The Vampire part comes from the reaction to light from the porphyrins that build up in the skin. Exposure to sunlight creates blisters and the skin to tear easily. The Werewolf nickname comes from the excessive hair growth.

This is an excellent example of a health situation where one may experience anemia that is caused by excessive ferritin and supplementing with iron is a very bad idea.

I had forgotten about all the reading I did on this. Brings back memories of before breast cancer. Wow.

rhondalea 11-30-2014 08:40 PM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
What's weird is that you would think heterozygotes would have some protection from low iron, but at least in my case, that's not the case at all. I've had intermittent anemia for most of my life, and with it comes very low ferritin, followed by restless legs. Given the alternative, it's just as well, I suppose--hemachromatosis can lead to some pretty dreadful ailments if untreated--but you'd think that the gene variants could have at least tried to arrange themselves with a little more utility.

I was just recently looking over some of the porphyria templates at Livewello (a third-party site where the 23andMe raw data can be analyzed). I don't think I'll ever figure out what this anemia business is all about--seems to be related to my thyroid--but I've certainly ruled all the more obvious explanations. I almost wish I'd been born 50-100 years later, because I'd really like to be around when our genes become less a mystery and more a guidebook for lifestyle.

'lizbeth 12-01-2014 09:43 AM

Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer
LMAO, I think there is a reason that you are living now.

When you are dealt cards can you pick 4 Aces every time? Nor can you pick which genes are hetero- or homozygous.

Perhaps the "corsets are too tight". You are attributing intermittent anemia to genes when the cause maybe unrelated, or indirectly related.

Stop promoting 23andme as a place for patients to get medical information. This is exactly why they got stomped by the FDA in the first place. Until the company alters its business model and offers that the test to be ordered by physicians the company is just digging a deeper grave. You are currently being part of the problem with 23andme, not part of the solution.

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