<![CDATA[The Blood Whisperer - Blood Whisperer Blog: Easy Opportunities For Real Precision Medicine Based on Real Lab Tests]]>Sun, 06 Aug 2017 21:47:31 -0600Weebly<![CDATA[Even Wilder than the Wild West, Direct-to-Consumer Testing.]]>Wed, 02 Aug 2017 06:00:00 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/even-wilder-than-the-wild-west-direct-to-consumer-testingWhile JAMA published an article (1) calling for regulation and oversight of direct-to-consumer testing, the even wilder than the wild west LDT world I discussed in my post of 7/23/17, companies like helix (2) are offering consumers directly the possibility of performing virtually unlimited DNA tests on single specimens.

The Helix homepage innocently depicts a smiling, quite-pleased-with-her-new-found-information model pushing a cow out of the way because her DNA tells her she has lactose intolerance. I wonder if it might not be more appropriate to show the following depiction of a patient who has received worrisome news from a DNA screen.
Companies like 23andme have received FDA approval to market DNA testing directly to consumers (3).  They received approval for the following tests (4):  23andme calls their offering:  Personal Genome Service Genetic Health Risk (GHR).  As pointed out in reference 3, the 23andme offering is a very limited screening of a few mutations scanned for in what amounts to a vacuum of information:  How many mutations are involved in these diseases?  How important is a single finding of a mutation with no additional context?  What is the person supposed to do with the information and how is a health care provider supposed to react when queried with the results from a company they have not interacted with and from whom they did not order the testing?

Please note that some of these diseases, when properly diagnosed in a clinical setting, have fairly negative consequences for patients:  Parkinson's and Alzheimer, for example. 

This is just a small glimpse of the avalanche of this kind of testing to come.  As I mentioned above, helix (2) is offering the possibility of multiple rounds of testing.  Already, 23andme is seeking to study 25,000 people with depression and bipolar disorder (5).

Even more worrisome in my opinion, is: Who is going to do what with this information?  And who is it going to be sold to (6)?
Read Much More About Over-Utilization of Lab Tests and Over-Diagnosis in My Book “Blood Trails…”
And be sure to read my book on the death of Edgar Allan Poe, "Decryption of the Death of Edgar Allan Poe."  My final diagnosis may well surprise you.The book is available as print-on-demand and eBook from Amazon.

https://www.amazon.com/Decryption-Death-Edgar-Allan-Poe-ebook/dp/B06X3TMHFD/ref=sr_1_2?ie=UTF8&qid=1499037143&sr=8-2&keywords=ralph+giorno
References
1.  JAMA. 2017;317(24):2485-2486. doi:10.1001/jama.2017.5929.
2. 
https://www.helix.com/
3.  DOI: 10.7326/M17-1045.
4.https://www.fda.gov/newsevents/newsroom/pressannouncements%20/ucm551185.htm.
5.  http://markets.businessinsider.com/news/stocks/23andMe-Begins-Enrollment-for-First-of-its-Kind-Study-on-Major-Depressive-and-Bipolar-Disorders-1002226131
6. https://www.scientificamerican.com/article/how-data-brokers-make-money-off-your-medical-records/
© 2017 by Ralph Giorno MD
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<![CDATA[CDC UPDATES ZIKA TESTING GUIDELINES]]>Tue, 01 Aug 2017 06:00:00 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/cdc-updates-zika-testing-guidelines
CDC has recently updated its guidance for management of potential or documented Zika virus infection in pregnant women (1).

The update includes the following key recommendations:

1.  All pregnant women in the USA should be asked about possible Zika virus exposure before and during pregnancy at every prenatal visit.
2.  Women with recent exposure or symptoms should be tested through 12 weeks after symptom onset. Testing includes concurrent nucleic acid test (NAT) and serologic (IgM) tests.
3.  Asymptomatic women with ongoing exposure should be offered testing 3 times during pregnancy.  Testing is NAT only, IgM NOT recommended.
4.  Asymptomatic women who have recent possible exposure but not ongoing exposure should not be tested.
5.  IgM testing for Zika virus should not be performed on non-pregnant women as part of preconception counseling.

In my opinion this is clearly a demotion of IgM testing.  I have previously discussed problems with some of the Zika IgM testing materials (post of 1/6/17).  The CDC article points out that IgM testing is prone to false positive results because of cross-reactivity with dengue and west Nile virus antibodies.  Both dengue and west Nile are fairly common infections depending upon the season and geographic location.

Read Much More About All Aspects of Medical Lab Testing in My Book “Blood Trails…”
And be sure to read my book on the death of Edgar Allan Poe, "Decryption of the Death of Edgar Allan Poe."  My final diagnosis may well surprise you.The book is available as print-on-demand and eBook from Amazon.

https://www.amazon.com/Decryption-Death-Edgar-Allan-Poe-ebook/dp/B06X3TMHFD/ref=sr_1_2?ie=UTF8&qid=1499037143&sr=8-2&keywords=ralph+giorno
References
1.https://www.cdc.gov/mmwr/volumes/66/wr/mm6629e1.htm?s_cid=mm6629e1_w
© 2017 by Ralph Giorno MD
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<![CDATA[THE DIAGNOSTIC ACCURACY AND INNOVATION ACT (DAIA), MUCH ADO ABOUT...?]]>Sun, 23 Jul 2017 18:42:27 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/the-diagnostic-accuracy-and-innovation-act-daia-much-ado-aboutDAIA is a proposed law to bring the wild west of medical laboratory testing, so-called laboratory developed tests (LDTs), under some sort of regulatory oversight.  LDTs have been rampantly proliferating in and unregulated environment. LDTs are putative diagnostic tests developed by individual laboratories that are implemented without FDA approval and within no regulatory framework.  Most laboratory tests are performed using test kits and instruments that have been approved by the FDA.  But not LDTs.  All a lab has to do is set up the test and begin offering it and, of course, charging for it.  The tests can range from the seemingly mundane, such as Vitamin D, to tests for various cancers, such as ovarian cancer, which can have devastating consequences in terms of surgery, chemotherapy and emotional suffering.

FDA has produced a document (1) outlining the issues with just a few LDTs. These tests are prolifertaing because of the hype about genomics and "precision medicine," whatever that is.  The FDA document illustrates some of the astoundingly audacious misuse of statistical manipulation to present faulty claims about various LDTs.

DAIA is a congressional proposal to regulate these LDTs, which are called IVCTs (in vitro clinical tests) in the proposed law.  In addition to regulating LDTs, the law also folds in areas currently regulated by FDA: manufactured test kits and testing instruments. The proposed law offers an extraordinarily generous five-year phase-in to allow IVCT developers to get their act together plus an additional 2 years to come into compliance.

I love the idea that medical labs foisting these LDTs on the public will be held to the same standards that commercial manufacturers must meet.  Laboratory organizations predictably do not like this proposal(2,3).  Professional societies interested in infectious disease testing also want a "public health exemption" so that they can put in place whatever tests they want for infectious disease outbreaks (3).

I am completely opposed to labs getting a "public health" loophole to put shoddy testing into place.  I have personally seen labs testing (one of which is mentioned in the FDA document, ref. 1) for infectious disease utilizing poorly documented performance studies and virtually non-existent clinical studies.  This is not to say that problems don't arise using test kits that are FDA approved, since I have seen plenty of problems using those materials as well.

Some organizations, such as the American Association for Clinical Chemistry (AACC) are strident in their opposition to the proposed law (2).  This organization states that the law would: 1) foster an anti-competitive environment; 2) stifle test innovation; and 3) hinder patient care.

Yikes, could be the end of the world if we start to regulate the wild west of lab tests.

But will it be that bad?  I mean right now the FDA is approving tests for which the only public information available is abstracts from presentations at medical meetings (see posting of 7/27/17).  Who knows how much data is being required by the FDA. 

I would prefer that labs or anyone else wanting to offer an IVCT should publish the findings for public analysis and comment, the information obtained then being reviewed by an FDA oversight entity which would determine whether the IVCT warranted approval.  This method would limit growth of yet another federal bureaucracy and put more power into the hands of health care consumers.

Read Much More About Laboratory Developed Tests And Over-Diagnosis in My Book “Blood Trails…”
And be sure to read my book on the death of Edgar Allan Poe, "Decryption of the Death of Edgar Allan Poe."  My final diagnosis may well surprise you.The book is available as print-on-demand and eBook from Amazon.

https://www.amazon.com/Decryption-Death-Edgar-Allan-Poe-ebook/dp/B06X3TMHFD/ref=sr_1_2?ie=UTF8&qid=1499037143&sr=8-2&keywords=ralph+giorno
References
1.  https://www.fda.gov/aboutfda/reportsmanualsforms/reports/ucm472773.htm.
2.  https://www.asm.org/index.php/statements-and-testimony/item/6409-ldt-leg.
3.  AACC letter Re: Laboratory Developed Tests and The Diagnostic Accuracy and Innovation Act, April 6, 2017.
© 2017 by Ralph Giorno MD
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<![CDATA[FDA Approval of Lab Tests Based On Published Meeting Abstracts Only?  Or Even Less Publicly Available Information?]]>Sun, 23 Jul 2017 13:54:40 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/fda-approval-of-lab-tests-based-on-published-meeting-abstracts-only-or-even-less-publicly-available-informationIt seems many new diagnostic tests are getting FDA approval with no peer-reviewed publications being available.  In the case of one test, only some meeting abstracts are available.  While I know that peer-review has many problems, there is no published material available for scrutiny by the medical and scientific company.  Yet many of these tests, most in genomics, are going to be sold to highly vulnerable patients who have received a devastating diagnosis, usually cancer.

What is receiving little discussion is the reliability of these extremely expensive tests and the extremely expensive treatments that are doled out based on their results.  See my post of 1/7/17 about disparate results obtained with genomic testing from different companies.  Are we all supposed to pay for this?  Especially when the life extension is marginal at best (see post of 5/5/17) and therapy may lead to explosive tumor growth (see post of 4/17/17).  Or will IBM's Watson figure it out for us at the cost of millions (see posts of 2/24 and 6/5/17?

At the same time, we have companies like 23andme and ancestry.com (apparently in conjunction with Quest Diagnostics) selling DNA testing that reveals, supposedly, not only your ancestry but disease-related information, such as, supposedly, information about neurodegenerative diseases.

What a thrill!

What people, including patients, don't think about because it is probably never explained to them is who else has access to this DNA information.  There are many information brokers out there selling this information to all sorts of interested parties and making a lot of money in the process.  It is a huge business.

Who are the interested parties?  Well, here are a few possible interested parties:  health insurance companies, life insurance companies, employers, banks, I am sure you can think of a few more.

The ready availability of this information astounds me.

Read Much More About Cancer Diagnostic Testing And Over-Diagnosis in My Book “Blood Trails…”
And be sure to read my book on the death of Edgar Allan Poe, "Decryption of the Death of Edgar Allan Poe."  My final diagnosis may well surprise you.The book is available as print-on-demand and eBook from Amazon.

https://www.amazon.com/Decryption-Death-Edgar-Allan-Poe-ebook/dp/B06X3TMHFD/ref=sr_1_2?ie=UTF8&qid=1499037143&sr=8-2&keywords=ralph+giorno
© 2017 by Ralph Giorno MD
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<![CDATA[The Fake Thyroid Cancer Epidemic]]>Sun, 02 Jul 2017 07:00:00 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/the-fake-thyroid-cancer-epidemicWe have a thyroid cancer epidemic caused by over-diagnosis. Finally, an official body is taking action to curb this nightmare.  The USPSTF (United States Preventive Services Task Force) has recommended against thyroid cancer screening in asymptomatic adults (1).

USPSTF RECOMMENDATION MAY 2017

Do not screen for thyroid cancer
Grade: D
What is a grade D?
D = The USPSTF recommends against the service.

There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.  Discourage the use of this service.

What Is The Problem? Over-Diagnosis Caused By Diagnosing Cancer on Inadequate Evidence.

Look at the graph above (ref. 2)....  It tells a sad story.

Number Of Cases of Thyroid Cancer Tripled.  But...
Death Rate = Absolutely No Change

Why did this happen?
Because
1.  Physicians encouraged to palpate (feel) thyroid to detect small nodules.
2. Physicians encouraged to ultrasound thyroid to detect nodules they can't even feel!
This led to an epidemic of fine needle biopsies of tiny thyroid nodules in which a needle is placed in a thyroid nodule as in the picture below.  This has occurred in asymptomatic adults with absolutely no known thyroid issues.
The booming industry of fine needle biopsies of the thyroid has led to pathologists diagnosing cancer completely out of context.  That is because what the pathologist obtains from a fine needle biopsy is a large number of glass slides loaded with cells which must be examined in minute detail because the only thing the pathologist has for calling the cells cancerous is the characteristics of the nuclei of the cells.  The pathologist has no other context for which to diagnose cancer, such as the universally accepted criterion of invasion.  So all the pathologist has is a boat load of cells smeared on a glass slide as shown in the figure below.
This hubris has led to up to 20% of cases being called cancer when indeed they are not cancer.  The truth on this has finally come out over the last few years with the re-categorization of these cancers as benign (not malignant) tumors, a photo of which is shown in the figure below.
This entity used to be called -- encapsulated follicular variant of papillary thyroid carcinoma, and was thought to be cancer.  But now it is called noninvasive follicular thyroid neoplasm with papillary-like nuclear features = Not Cancer!

And the name of this benign tumor demonstrates that pathologists were guilty of massive over-diagnosis because the only feature they were looking for was the nuclear signature of true thyroid papillary cancer.  This is not just a word game because of the

Potential Harms or Thyroid Cancer Screening

You get to buy thyroid pills for rest of your life (if you have total thyroid removal)

Radiation damage (scarring, inflammation)

Nerve damage (hoarseness, difficulty speaking)

Parathyroid damage (problems with calcium regulation)                    

And We Wonder Why American Medicine Is So Expensive?

Read Much More About Cancer Diagnostic Testing And Over-Diagnosis in My Book “Blood Trails…”

And be sure to read my book on the death of Edgar Allan Poe, "Decryption of the Death of Edgar Allan Poe."  My final diagnosis may well surprise you.
References
1. US Preventive Services Task Force. Screening for Thyroid Cancer US Preventive Services Task Force Recommendation Statement. JAMA.2017;317(18):1882-1887.
2. Davies L,Welch HG. Current Thyroid Cancer Trends in the United States. JAMA Otolaryngol Head Neck Surg.2014;140(4):317-322.
3. Nikiforov YE et al. Nomenclature Revision for Encapsulated Follicular Variant of Papillary Thyroid Carcinoma. JAMA Oncol.2016;2(8):1023-1029.
© 2017 by Ralph Giorno MD

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<![CDATA[IBM Watson Back in The Cancer Business.... How Much Can It Waste This Time?]]>Mon, 05 Jun 2017 20:17:10 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/ibm-watson-back-in-the-cancer-business-how-much-can-it-waste-this-timeMy post of 2/24/17 discussed how MD Anderson Cancer Hospital in Houston blew through 62 million bucks and received nothing in deploying the IBM Watson technology for something called "Oncology Expert Advisor (OEA), a cognitive clinical decision support tool powered by IBM Watson."

Now IBM is back with Watson supposedly helping Novartis (mega-pharma concern) on something called "outcomes-based care in advanced breast cancer (1)." It seems the Watson supercomputer is supposed to "use real-world patient data and cognitive computing with aim of improving outcomes in advanced breast cancer (1)."

You will recall how the MD Anderson program was supposed to use Watson:  "...
OEA is able to generate dynamic patient case summary by interpreting structured and unstructured clinical data and suggest personalized treatment options with reasonably high accuracy. Live system evaluation of OEA is ongoing and application of OEA in clinical practice is expected to be piloted at our institution (2/24/17 post).”

How much money will get thrown into this project, another $62 million?

Speaking of money, oncology researchers are lamenting the fact that they ain't gettin' enough dough from the National Cancer Institute and that "America may be losing its edge in medical research (2)."  Even more lamentable, apparently, is "I fear we are losing a generation of young, talented biomedical scientists.”

Oh really?  So we need to spend even more money to get misleading test results (see post of 1/7/17), or so-called "precision medicine" that causes explosive cancer growth (see post of 4/17/17), or fancy "multi-gene" test panels that might prolong your life for less than a week (see post of 5/5/17) or clinical trials where about 100 studies are clearly statistically wrong (3), in which the data are either fraudulent or grossly mishandled?

In my opinion, America is unfortunately doing with biomedical "research" what it does with our education system: throwing enormous amounts of money at inferior products; we have the most expensive health-care in the world, but other places have people living longer at far lower costs; we have the most expensive education system in the world, but we produce an embarrassingly dismal product.

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<![CDATA[Is This Headline for Real?]]>Fri, 05 May 2017 21:25:13 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/is-this-headline-for-realPicture
I am trying to find the "precision" in this so-called precision medicine.

On May 4, 2017, LabMedica Clinical Lab News published the lead story shown in the picture on the left, with the headline "Multigene test extends life expectancy for cancer patients (1).

Oh really?

The story refers to a very strange paper (2) in which the authors use "hypothetical," that is, not real, groups of breast cancer patients based on a computer simulation in which they purport to show that a 7-gene panel gives more actionable information than the BRCA1/BRCA2 gene testing currently employed in some breast cancer patients.  I find the data they present to be extremely puzzling.  The authors claim that 7-gene testing compared to "usual" BRCA1/2 testing extends life by less than a week.  Now that is an impressive result!

Even in these idealized groups of "not real" patients, there is virtually no advantage that I can see for 7-gene testing as opposed to BRCA1/2.

But the most disturbing thing to me is that the headline indicates that this multi-gene test is extending lives, as if this is an actual fact, rather than a computer simulation.

Reality is that even BRCA1/2 testing is not cost-effective as a universal screening test (3).

The scary thing about some of these headlines and hype calling for genetic screening for everything including the kitchen sink is that they ignore the value of doctors actually talking to their patients and taking good medical histories.  Even worse, they lead an unsuspecting public to believe that screening for more and more genes is a cure-all for literally every disease.

And, as I already mentioned, the lead news item (1) and the article it refers to (2) are based on a computer simulation of "hypothetical," not real, "patients."  The practice of medicine should not be based on computer simulations.
References
1.  https://www.labmedica.com/pathology/articles/294769108/multigene-test-extends-life-expectancy-for-cancer-patients.html.
2.  Li Y et al.  A multigene test could cost-effectively help extend life expectancy for women at risk of hereditary breast cancer.  Value in health 20: 547-555, 2017.
3.  Long EF, Ganz PA.  Cost-effectiveness of universal BRCA1/2 screening. Evidence-based decision making.  JAMA Oncol 1: 1217-1218, 2015.
© 2017 by Ralph Giorno MD
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<![CDATA[Scientists Are Marching on April 22, Yet They Have the Nerve to Offer Us This Drivel?]]>Fri, 21 Apr 2017 22:34:49 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/scientists-are-marching-on-april-22-yet-they-have-the-nerve-to-offer-us-this-drivelPicture
So it's earth day, and these self-righteous so-called scientists can march for science, too bad they don't mind their statistics and produce decent science since they are all living on taxpayer dollars.  Narcissistic wimps!

An open letter (1) by Romain-Daniel Gosselin, PhD Founder, C.E.O. and C.S.O. Biotelligences LLC, Lausanne, Switzerland, revealed widespread shoddy statistical practices in "major" bio-medical journals, including Cell, Cancer Cell, Science, Science Advances, Nature, Nature Communications, Journal of Clinical Investigation, P.N.A.S., P.L.o.S Biology and Molecular Psychiatry.

These so-called scientists, from virtually every corner of the globe, do not make clear or do not even bother to tell us their sample sizes in from 20% to 80% of Gosselin's sampling of recent articles.  Likewise, they do not bother to make clear the exact statistical tests employed in specific experiments in up to 40% of the cases.

As Gosselin states:

"The safe-conducts given by the editorial system to articles that do not disclose exact sample sizes are shocking. Science must be based on the possibility to repeat comparable designs, which obviously encompasses the use of similar numbers of observations."

Gosselin specifies just how ludicrous the shoddy science is by giving examples of obfuscation when it comes to sample sizes:

"Sample sizes given as intervals (e.g. “n=3-18”), inequalities (e.g. “n>3”) or absurdly nebulous sentences (e.g. “n=4, data representative of 3 rats from 2 independent experiments”) are evident obstructions to reproducibility."


It irks the hell out of me that world tax dollars are being squandered on this excrement and that these people have the audacity to march around on "earth day" essentially demanding that their cushy lifestyles remain undisturbed while the rest of us slave away.  Perhaps instead of marching around being impressed with themselves for publishing patently incorrect rubbish, these so-called scientist should clean up their acts, or better yet, take Dr Gosselin's courses on statistics.
References
1.  http://en.biotelligences.com/open-letter.html
© 2017 by Ralph Giorno MD
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<![CDATA[Is This Precision Medicine?  Your Precisely Sized Breast Implants Have Caused a Very Precise Cancer or Perhaps a Very Precise Autoimmune Disease]]>Sun, 02 Apr 2017 22:52:16 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/is-this-precision-medicine-your-precisely-sized-breast-implants-have-caused-a-very-precise-cancer-or-perhaps-a-very-precise-autoimmune-diseaseOn March 23, 2017, FDA issued the following bulletinBreast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).  Yes, those marvelous implants are associated with a cancer called Anaplastic Large Cell Lymphoma (1-4). The Figure Below is a PET scan of one of these breast cancers.
The Figure above (from ref.1) is a fused 18F-FDG PET/CT scan of the chest axial plane showing abnormal heterogeneous increased FDG uptake of the left breast mass [Anaplastic Large Cell Lymphoma] extending through the left chest wall (arrow).

The Figure below shows the cancer cells from an Anaplastic Large Cell Lymphoma.

Here I provide the full text of the FDA bulletin (https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239995.htm):
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma.
At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk. In a report summarizing the Agency's findings, we emphasized the need to gather additional information to better characterize ALCL in women with breast implants.
Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.
We continue to collect and evaluate information about ALCL in women with breast implants. On an ongoing basis, we:
·        Receive and review medical device reports (MDRs).
·        Review the current medical literature.
·        Exchange information with other international regulators and scientific experts.
·        Review data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE Registry) (a collaborative effort with the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation (PSF).
·        Review information that breast implant manufacturers include about BIA-ALCL in their patient and health care professional labeling.
In 2016, there were several advances in the description of the disease and treatment recommendations.  These are described below:
·        The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that can develop following breast implants.
·        Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) published information to help physicians understand the disease and provide diagnosis and treatment.
·        Regulatory bodies outside the United States issued communications on BIA-ALCL. 
o   The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. TGA estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.
o   The French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings within a year.
Medical Device Reports
As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.
It is important to note that details on breast implant surface and fill type are limited. While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data. Over time, we may gather more information about a report and thus the numbers listed above may change.
In addition, the incidence or prevalence of an event cannot be determined from the MDR reporting system due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants.
Medical Literature
A significant body of medical literature has been published since our 2011 report, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease. Most of the cases in the literature reports describe a history of the use of textured implants. Several recent journal articles explore the risk factors for BIA-ALCL, including the methods used to create surface texture of the implant and the role of biofilm in causing disease, among others. All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.
Recommendations
Health Care Providers:
If you have patients with breast implants, you should continue to provide them routine care and support. BIA-ALCL is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.
Current recommendations include the steps below.
·        Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants.  Provide the manufacturers' labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.
·        Consider the possibility of BIA-ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer her to an appropriate specialist for evaluation. When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.
·        Develop an individualized treatment plan in coordination with the patient's multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
·        Report all confirmed cases of ALCL in women with breast implants to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.
·        Submit case reports of BIA-ALCL to the PROFILE Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.

But this is not all you get for your money with enlarged breasts

You might also get an autoimmune disease called ASIA (Autoimmune/inflammatory syndrome induced by adjuvant; ref. 5).  According to a recent review (5), the following appear to be risk factors predisposing to development of ASIA.

Prior documented autoimmune reaction to an adjuvant
        Vaccine or Previous Implant
Established autoimmune condition
        SLE (lupus), Hashimoto, Graves, type 1 diabetes, rheumatoid arthritis, etc
History of allergic conditions/atopic disorders
        Eczema, hay fever, pollen and dust mites allergy, drug allergy, and rubber or         Latex allergy

Prone to develop autoimmunity
        Various genetic markers, obesity, smoking


Oh!  The joys of "precision medicine!"



References
1.       Binmahfouz A, Steinke K. A case report of breast implant-associated anaplastic large cell lymphoma: The good, the bad, and the ugly. Int J Case Rep Images 2016;7(8):537–541.
2.      De Jong D et al.  Anaplastic Large-Cell Lymphoma in Women With Breast Implants.  JAMA 300: 2030-2035, 2008.
3.      Kim B et al.  Breast Implant–associated Anaplastic Large Cell Lymphoma: Updated Results from a Structured Expert Consultation Process.  Plast Reconstr Surg Glob Open 2015;3:e296; doi: 10.1097/ GOX.0000000000000268.
4.      Roden AC et al.  Seroma-associated primary anaplastic largecell lymphoma adjacent to breast implants: an indolent T-cell lymphoproliferative disorder.  Modern Pathology (2008) 21, 455–463.
5.      Goren I et al.  Autoimmune/inflammatory syndrome induced by adjuvant (ASIA) evolution after silicone implants. Who is at risk?.  Clin Rheumatol DOI 10.1007/s10067-015-2931-0.

© 2017 by Ralph Giorno MD
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<![CDATA[How Much Precision Medicine Do You Get for 62 Million Bucks?  None, Zippo, Zilch, That's How Much]]>Fri, 24 Feb 2017 20:22:57 GMThttp://bloodwhisperer.com/blood-whisperer-blog-easy-opportunities-for-real-precision-medicine-based-on-real-lab-tests/how-much-precision-medicine-do-you-get-for-62-million-bucks-none-zippo-zilch-thats-how-much Here is a quote from a glowing report in an American Society of Clinical Oncology (ASCO) meeting abstract in 2014 (1):

“We developed a web based prototype of MD Anderson’s [MD Anderson is in Houston TX] Oncology Expert Advisor (OEA), a cognitive clinical decision support tool powered by IBM Watson. The Watson technology is IBM’s third generation cognitive computing system....  OEA is able to generate dynamic patient case summary by interpreting structured and unstructured clinical data and suggest personalized treatment options with reasonably high accuracy. Live system evaluation of OEA is ongoing and application of OEA in clinical practice is expected to be piloted at our institution.”

Less than 3 years later, a blistering audit by the state of Texas on the system states that $62 million was spent and there is nothing to show for it (2).  I quote from the audit:

“Through August 31, 2016, approximately $62.1 million has been paid to external firms for planning, project management, and development of OEA.  More than half of the funding used towards the system came from restricted gifts donated or pledged specifically for this purpose.  This total reflects payments to external entities only; it does not include internal resources such as staff time, technology infrastructure, or administrative support.  OEA has not been updated to integrate with MD Anderson’s new electronic medical records system, and is not in clinical use.”

According to Fierce Biotech reporting (3):

“The audit found that, as of Aug. 31 last year, MD Anderson paid out more than $62 million to external firms—namely, IBM and PricewaterhouseCoopers [PWC], which made a business plan for the product—but had no product to show for it.”

That’s right:  Texas paid over $62 million to IBM and PWC and got zilch for for this so-called 'precision medicine' project.  But maybe Texas isn’t too concerned about it because a Forbes article (4) indicates that the Washington Post (WaPo) reported that entrepreneur Lo Taek Jho forked over most of the cash.  Apparently the guy is under investigation by the Department of Justice.  The Texas audit does however point out that the $62 million does NOT include all the infrastructure, staff and administrative support costs for the failed project.  Will Texas ask IBM and PWC for a refund?

As is its wont, the WaPo had a glowing article on the OEA in 2015 (5), replete with cool color optics, glowing reports from ‘oncologists in training,’ and a detailed history of how Watson, IBM’s supercomputer behind OEA, was going to change the world.

This is what ‘Precision Medicine’ is getting for us?  What a great scam!  Instead of spending over 60 million smackers on patient care, you know, common-sense stuff like making sure terminal cancer patients are sufficiently medicated to ease suffering, making sure they are properly channeled to reputable hospice organizations to help them and their families with a devastating illness, Texas (and apparently Mr Jho) poured all of that money into IBM and PWC.  No doubt, the executives of those outfits like what they got out of the deal.  Even more amazing, as the Forbes article (4) points out, instead of IBM paying MD Anderson to test their product, MD Anderson (or Mr Jho) paid IBM.  Nice!

IBM meanwhile is capitalizing on its magnificent Watson system by moving on to other things, interestingly unrelated to oncology.  According to the Fierce Biotech article (3) IBM has unleashed Watson on 'Clinical Imaging Review.'  In the good old days, ‘imaging’ used to be called ‘radiology,’ but ‘imaging’ is now the accepted word.  Talk about nondescript!  IBM is also moving into ‘population health’ with the Central New York Care Collaborative.  With another outfit called Atrius Health they are getting into ‘shared decision making’ between doctors and patients.  So many cool buzzwords:  ‘shared decision making,’ ‘population health,’ ‘imaging.’  I can feel the cash flow now!

I wonder how many millions these additional IBM targets will contribute to the coffers.

I continue to be amazed at where fabulous ‘Precision Medicine’ is taking us.

© 2017 by Ralph Giorno MD
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