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HOW TO PAY FOR YOUR Myeloma Treatment??    Part 2  -  You Have Private Insurance Or No Insurance

2/11/2019

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PictureMyeloma Patient's Financial Life Boat
So you have multiple myeloma!  Most people have never heard of myeloma, or have any idea it is considered incurable.  If you are like most, it is a shock, and overwhelming.  In addition, it becomes a journey, including a maze of  financial worries.  This blog post is meant to assist you in getting through this financial maze!

Usually, people obtain Private Insurance by way of their employer, and it will vary wildly from the gold plated programs to very basic plans with high deductibles, high co pay percents, and high monthly employee costs to participate.  If you have  one of the better plans,like that for union railway workers, they still pay 21%(CLICK HERE for the source) of their yearly health care costs.  It is likely most insured would  find it difficult to afford the high cost of myeloma treatment, which can easily approach $626,000 in the first year without additional financial assistance.  The cost of insurance, co pays, and deductibles can easily reach $20 to $30 thousand in the first year alone.
 
So with or without insurance how do you afford the shortfall?

The non insured need to find a way to get insured as soon as possible.  The Affordable Care Act  (ObamaCare) is one possibility, however open enrollment period is usually only two months long and you may need help now.   CLICK HERE to view the ACA program details.  You may apply for Medicaid and obtain coverage, and if turned down for Medicaid you are then eligible to apply for the ACA program at any time during the year.  CLICK HERE. Finally you can get Medicare and that is  what I and many other myeloma patients have done. If you do not have insurance or have no access to care, the average life expectancy is less than one year.  However, Medicare has a Compassionate Allowance Program where you can be approved in less than two weeks if you go to your local office and can show that you will not live without care.  To see the program CLICK HERE.

So now the uninsured are insured, and fall in the same category as the insured!  How then does this group obtain the funds to handle the cost of Insurance, co pays, deductibles, and high cost of myeloma treatment and drugs?

First of all go back to Part 1 of this series (CLICK HERE)
 and take advantage of all the third party co pay programs which you qualify for.  Just note a few are listed as just for Medicare patients.  You can find a listing of all of these co pay programs if you CLICK HERE.

Second, and this is a great benefit for all who have private insurance, or if you want treatment and are not yet insured this may apply to you.   The drug companies can provide direct copay funding to anyone who has no insurance, or private insurance.   Drug companies want you to take their drugs and would love to do the same for Medicare and Medicaid patients, but their misguided effort to ensure these programs only use generic drugs has also affected most cancer drugs which have few if any generics.  The solution to this would be to exclude all patented and or cancer drugs without a generic equivalent from this ruling which DISCRIMINATES against senior and disabled cancer patients!  Most of these programs have income limits but Celgene has recently removed their income limit requirement. The following are links to drug sponsored co-pay assistance programs. Just click on the red highlighted lines.  

Celgene
  • Thalomid, Revlimid, & Pomalyst
  • Celgene patient support web portal
Takeda
  • Ninlaro 1Point Program
  • Velcade Support
Amgen
  • Kyprolis
  • Amgen Assist 360 Program
Janssen 
  • Darzalex
  • Janssen CarePath Program
​
Good luck and God Bless your Myeloma Journey/ [email protected]
For more information on multiple myeloma CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1


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HOW TO PAY FOR YOUR Myeloma Treatment??    Part 1

1/28/2019

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Picture CO PAY Assistance - The Myeloma Patient LIfe Raft
I have heard from many patients in the United States and they frequently voice fear and concern on how they will afford their medications, doctor and hospital bills. This should not happen in the richest county in the world, and I believe most people can afford treatment if they just knew how to work our convoluted health care system.  The top 1% earn $422,000 per year and I would assume great insurance and can cover their co pays and deductibles.  However. two classes of patients do have concerns of how to afford life saving treatment.  The first is the 36%, or those who either have no insurance or private insurance(average $58,000 yearly household income), and the second would be the 63%, or those 65 years or older who are on Medicare (married $48,000, single $19,000).

To provide an adequate evaluation of how to afford your life saving myeloma treatment, I will look at each of these two categories separately, and do the largest group first as Part 1.  This group may have a few additional challenges which younger patients may not have. All have some of these same challenges. 

1) I have found 85% of patients go to a community oncologist.  They usually have a small staff and do not provide adequate financial counseling.
2)  Many want to know what insurance you have, or some do not accept Medicare. They want to know they will get paid! 
3)  Smaller offices do not see many myeloma patients and they may not know what financial help is available by the drug companies or by LLS, PAN, and other third party co pay assistance programs.
4)  Patients do not know they can apply to more than one program.
5)  Drug companies can not reach out to patients using their drugs and inform them of the help available because federal rules prevent it.
6) If you are on Medicare federal law prevents any co pay assistance directly from drug companies.  So to provide assistance, drug companies and others provide funds to third party providers like LLS(Leukemia, Lymphoma Society) to provide funds for co pay assistance.
7)  So if your doctor is too busy and does not have the staff to cover it, and drug companies can not tell you third party providers  have these funds available to you, how do you find out about them?  YOU MUST FIND OUT YOURSELF! You go to the LLS site, the IMF(International Myeloma Foundation) site, find out from other patients, or at local LLS, IMF or MyelomaCrowd support group meeting. 

You need to know the doctors, drug companies, and third party co pay assistance programs really do want you to get financial help to take your medicines.  If you live they have a patient longer, they make more money and you live longer.  WIN, WIN! That is why they provide the financial assistance.  So lets just look at an example.  A low risk patient (85%) of the total patients, and the standard of care is VRd induction, Stem Cell Transplant(if the patient is fit), VRd consolidation, and Rd maintenance(2years).

The first cost is for Medicare Part A, B, D & F.  Cost                  $4,900/yr
VRd Induction                                                     Velcade             27664
                                                                            Revlimid            42130
Stem Cell Transplant                                                                   250000 (varies in vs. outpatient, & wildly from $120,000 to $500,000)
VRd Consolidation                                                                         48729
Revlimid Maintenance                                                                  252600

TOTAL FIRST YEAR COST                                                       $626023

My best guess is that even with all of the Medicare coverage for A, B, D, & F,  the plan costs,  co-pays and deductibles will run in the $20000 to $30,000 range.   The drug companies know someone making just $48,000 per year can not suddenly spend half of their income on medical bills, so they develop these programs so you can buy their drugs and services.  It is part of their economic model. They will pay $20,000 or $30,000 of your co pay costs so they can receive more of the $626,023 for the first year of treatment.    They want you to find out about these funds and want you to use them, they just can not by federal law play any part in promoting or informing the patient of their existence.  IT IS NUTS, but was put in place so Medicare patients would buy generic drugs instead of getting an incentive from drug companies to buy their branded drug.  For example generic sertraline vs. Zoloft or simvastatin vs. Lipitor.   However, most cancer drugs do not have a generic alternative and any drug that is covered by a patent MUST BE exempt from this federal law. 

So how do people on Medicare find out about these available funds which can save their lives.  Unfortunately it will  continue to be the current ineffective way, like this blog post and word of mouth.  I found out through an IMF support group meeting!   I wish drug companies would promote these sources of funds though third part national advertising.  People deserve to KNOW!!!

So how do you find where you can get these funds?  A great resource is the IMF web site.  CLICK HERE!   This link shows what programs are currently available from the third party providers.  You can apply for more than one, and you will need to do so to cover the first year costs.  For example you can obtain the following funds:

Leukemia, Lymphoma, and Myeloma Society Co Pay Assistance Program -  $11000    CLICK HERE for the link

Patient Assistance Network                                                                           -  $15600    CLICK HERE for the link

Patient Advocate Foundation                                                                         -  $10000    CLICK HERE for the link

Should you get approved for each of these awards, you can easily cover your insurance, co pay, and deductible costs. The current system is a mess and complicated by government limits on medicare co pay, limits on Medicare negotiating drug prices, and PBM's (physicians benefit mangers) who charge co pays based on list price not net prices.  Until our convoluted system is rationalized, Medicare myeloma patients must find the funding this way to ensure they stay with the living.  Part B of th
is blog post will cover the 36% patients without insurance or private insurance, and will in the next few weeks.   A big plus for this group is Drug companies are not prevented from providing direct assistance, but still can not directly market the help to this group.

Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Mayo Clinic Rochester Publishes Updated Multiple Myeloma Survival Rates!

12/23/2018

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When I was first diagnosed with multiple myeloma 13 years ago, I conducted a search of the available information on which facilities had the best survival rates.  To my total surprise I found very little information.  Mayo clinic published their data and it was disappointing at just 33 MONTHS, the consolidated National Cancer Institute's data base mirrored the Mayo information.  The only other published information I found was for The Myeloma Institute at UAMS.  They published a life expectancy of an average of 7 years.  I was treated at Mayo and they got my myeloma under control, but I chose to have the majority of my treatment at UAMS, hoping for the extra 4 years.  Now being nearly 13 years post diagnosis, I think choosing a treatment facility on a data driven basis was a great decision.   Now fast forward to 2018 and Mayo Clinic's myeloma survival  has made quantum leaps. Transplant eligible patients (whether they have a transplant or not) can expect to be alive for more than 10 YEARS.  I just updated the Mayo data on the web site www.myelomasurvival.com and state the following:

Mayo Clinic(Dr. Vincent Rajkumar), Rochester, MN - The Mayo Clinic published an update of their myeloma survival rates for transplant eligible patients  and posted it on line  12/3/2018.  They reported Overall Survival (OS).   OS includes death from all causes and The SEER data is based on Relative Survival which excluded non myeloma deaths.   The Mayo Relative Survival rates are 95.9% at 2 years versus the SEER rate of 72% and 89.8% at 4 years versus the SEER rate of 57.7%  When compared to the SEER rate you are 6 times more likely to die in 2 years and 4.1 times more likely to die in 4 years at the average SEER facility than if you were under the care of the Mayo, Rochester.  You can see a graph of the data if you CLICK HERE. This data is reflected in an OS study of 518 consecutive transplant eligible patients seen at Mayo Clinic. An outline of Mayo's risk adapted treatment template called mSmart can be found at the attached link: http://www.msmart.org/

As noted, Mayo and most programs provide their data as Overall Survival(OS), and the National Cancer Institute adjusts the data to exclude the non myeloma deaths.  This measure is called Relative Survival(RS), so to make a comparison of Mayo's information to that listed on the NCI SEER data base, I have adjusted the Mayo data to reflect Relative Survival.  The graph  below is this comparison.
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Some very eye opening observations include 1) 17.2% of patients do not survive the first year if treated at the average SEER facility, whereas less than 1% of Mayo's patients do not survive year one.   This huge difference in surviving the first year is a major element in overall survival.  2) The difference or spread in the two lines widens with time, so the improvement over the average SEER facility also improves. 

In addition if there is to be any true cure, the Mayo graphs slope need not flatten but be less than or equal to the slope of the Social Security Life Tables.  If the blue line continues to run parallel or the gap between the blue and gray line does not get larger, this I might argue is the definition of cure.  What this means is the remaining population of myeloma patients is dying at a pace less than or equal to the national average of all people. 

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With all the new treatments now being used by the top myeloma facilities and the outstanding CAR T, BiTE, ADC  and other clinical trials available to their patients, these rates for Mayo most likely will improve.   These improved rates would be expected to be duplicated at other top academic centers of excellence.  Continued  improvement in myeloma life expectancy is not an if, but more likely WHEN! 

The Christmas and Holiday Gift to mankind is the mSmart template published by Mayo Clinic(CLICK HERE) which outlines the process they go through to reach these excellent survival rates.  If the local hematologist/oncologist throughout the world are able to follow this template for treatment and supportive care the myeloma survival throughout the world may improve significantly.  This is the only open source treatment template widely available.  The next step will be individualized myeloma care based on the Health Tree being co-developed by Dr. Rafael Fonseca of Mayo and Myeloma Crowd.



Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1
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Best Of The Best Myeloma Abstracts For ASH2018! Dr. Shaji Kumar of Mayo Rochester Selects His Top 5!

12/21/2018

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There  are 828 abstracts listed for multiple myeloma for ASH 2018.  If you want to know which abstracts are most important why not ask some of the most talented myeloma specialists in the world.  And  that is just what we did.  Dr. Shaji Kumar was kind enough to list his top 5 in there order of importance

Dr. Kumar is the Professor of Medicine,  Mayo Clinic College of Medicine, Consultant, Division of Hematology, Medical Director, Cancer Clinical Research Office, Mayo Clinic Rochester, Minnesota.  Dr. Shaji Kumar’s research team evaluates the in vitro activity of novel drugs that, based on their mechanisms of action, are likely to have activity in the setting of myeloma. Promising drugs are brought into the clinic through early-stage clinical trials in Phase I or II studies. Dr. Kumar conducts National Institutes of Health-funded research on translation of novel therapeutic targets in multiple myeloma, understanding the mechanism of disease progression from monoclonal gammopathy of undetermined significance to active myeloma, and mechanisms of high risk disease. He also receives funding from the Multiple Myeloma Research Foundation to study the relationship between molecular profiles, treatment regimens for patients with multiple myeloma and outcomes and various clinical trials in relapsed multiple myeloma. 

One of the his many achievements includes his work with other US myeloma specialists, Dr. Noopur Raji, and Dr. Sundar Jagannath and several from India to provide a myeloma treatment template for India much like the mSmart program in the USA.  It is called the Consensus in the Management of Multiple Myeloma in India. To view CLICK HERE.

Dr. Kumar's Top 5 in there order of importance are as follows.  Click on the abstract number or the title to go directly to the expanded  abstract explanation.


1) Abstract LBA-2 - Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA)

Phase 3 trial of upfront Dara

2) Abstract 301 - Maintenance Therapy with the Oral Proteasome Inhibitor (PI) Ixazomib Significantly Prolongs Progression-Free Survival (PFS) Following Autologous Stem Cell Transplantation (ASCT) in Patients with Newly Diagnosed Multiple Myeloma (NDMM): Phase 3 Tourmaline-MM3 Trial

First randomized trial of a PI maintenance

3) Abstract 1010 - Treatment with AMG 420, an Anti-B-Cell Maturation Antigen (BCMA) Bispecific T-Cell Engager (BiTE®) Antibody Construct, Induces Minimal Residual Disease (MRD) Negative Complete Responses in Relapsed and/or Refractory (R/R) Multiple Myeloma (MM) Patients: Results of a First-in-Human (FIH) Phase I Dose Escalation Study

New immune modality, the preliminary results appear exciting

4) Abstract 955 - Updated Analysis of a Phase 1, Open-Label Study of LCAR-B38M, a Chimeric Antigen Receptor T Cell Therapy Directed Against B-Cell Maturation Antigen, in Patients with Relapsed/Refractory Multiple Myeloma

This trial has excellent responses and the follow up gives some sense of the durability



5) Abstract 305 - Efficacy and Feasibility of Dose/Schedule-Adjusted Rd-R Vs. Continuous Rd in Elderly and Intermediate-Fit Newly Diagnosed Multiple Myeloma (NDMM) Patients: RV-MM-PI-0752 Phase III Randomized Study

Importance of dose modification in elderly

Dr. Kumar, thank you for all you do for the myeloma patient community throughout the world.





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ASH 2018 - After CAR T What Is The Next BIG Area For Myeloma Treatment Progress? ADC(Antibody Drug Conjugates)?

12/20/2018

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Although CAR T has just made it to the clinic after more than 10 years of being studied in ASH abstracts, the explosion in the number of new CAR T abstracts bodes well for many more FDA approvals.  If you  look at the data from the 2018 abstracts you can see an almost identical explosion in abstracts for Antibody Drug Conjugates (ADC).  The graph which follows shows the beginning of the same exponential growth which was exhibited by the growth in CAR T abstracts.  
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Antibody Drug Conjugates (ADCs) are monoclonal antibodies (mAbs) attached to biologically active drugs by chemical linkers. By combining the unique targeting of mAbs with the cancer-killing ability of cytotoxic drugs, ADCs allow sensitive discrimination between healthy and diseased tissue.   Some patient friendly articles on ADCs can be seen if you CLICK HERE or HERE. 

A lot has been written about ADC's recently, and some of the most interesting revolved around the new Glaxo Smith Kline ADC GSK2857916.   This drug has shown twice the the Overall Response Rate (ORR) than did Daratumumab as a single agent in clinical trial.   GSK2057916 had a ORR of 60% and Darzalex had a 29% ORR.  At the time 29% was a giant leap forward. 
Not to be left behind Daratumumab has been turned into a AWC(Anitbody Warhead Conjugate) by the biotech company Actinium Pharmaceuticals, Inc.(ATNM)  This AWC showed a 10 fold improvement in myeloma cell death in vivo vs. Darzalex alone.  Finally, Takeda has a new CD38 antibody called TAK-079 and they are partnering with the biotech Molecular Templates(MTEM) to manufacture what they call a ETB(Engineered Toxin Bodies).  All use the same technique to link a toxin to an antibody with a linker.

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ADC is on the same trajectory as CAR T was just 3 years ago.  If you look at the graph to the left, ADC is tracking identical to CAR T and we can expect to see continued exponential growth for ADC abstracts with FDA approvals to follow. 

Targeted therapy has been touted as the future of cancer treatment, but not until recently have we had such a rush of new developments.  Large companies like GSK, Takeda, and Jannsen, small companies like Juno and Kite, and micro companies like Actinium, and Molecular Templates are changing the course of myeloma treatment more focused on the myeloma cancer cell target.  If Cytoxin and Melphalan are the shotgun approach to cancer care, CAR T and ADC are the one shot one kill approach to care!


Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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ASH 2018 Is An Amazing CAR show!  Chimeric Antigen Receptor(CAR)

12/17/2018

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It is interesting to note that just 10 years ago in 2009 there was just 9 CAR T abstracts in a total of 5176 total abstracts presented at ASH 2009.  It has also taken 10 years to get just 2 FDA approved CAR T treatments approved.  However for ASH 2018 there are 423 CAR T abstracts or 47 times as many.  As can be seen in the following graph the growth has been exponential.  It takes between 10 and 15 years to bring a drug from lab to clinic, so we can hope new CAR T approvals will also be exponential. 
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The data in this graph is from a search from the ASH abstract listing for the last 10 years.  You can find the 2018 listing if you CLICK HERE. CAR T seems to be a recent development, however it has been well over 10 years in the making.  There has been a lot of excitement around CAR T, but as can be seen from the growth in abstracts, this looks to be just the tip of the iceberg
New trials with multiple antigens targeted are being developed, as are many more antigens being identified as targets.  Not to be left behind, multiple myeloma has had a similar explosion in the number of new abstracts.
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As you might remember, myeloma represents just 1.8% of all cancers and historically has had more than it's share of the new drugs which have been developed.  The same holds true for the percentage of myeloma CAR T abstracts.  Of the 423 CAR T abstracts, 104 of them are myeloma CAR T abstracts, or 25% of the total.  This represents 14 times as many abstracts as one might expect based on the myeloma patient volume.  Recently Dr. Vincent Rajkumar recently presented a listing of 8 CAR T abstracts which he found of interest.  Dr. Rajkumar is one of the finest myeloma specialists, and his focus on CAR T helps to signify how very important this targeted treatment has become for the future of myeloma treatment.  His list is below and it you CLICK on the red Abstract Number it will go directly  to the ASH abstract.




1) Abstract 955 - Updated Analysis of a Phase 1, Open-Label Study of LCAR-B38M, a Chimeric Antigen Receptor T Cell Therapy Directed Against B-Cell Maturation Antigen, in Patients with Relapsed/Refractory Multiple Myeloma
Update of known CAR-T LCARB38M: results look similar to bb2121 with median PFS of 15 months. We need more follow up to know what % patients have enduring responses.

2) 2nd gen” BCMA CAR-Ts - for want of a better term: All show promising activity. Problem is going to be how they make it to FDA approval. 
Abstract 956 - Durable Remission Achieved from Bcma-Directed CAR-T Therapy Against Relapsed or Refractory Multiple Myeloma
Abstract 1012 - Efficacy and Safety of P-Bcma-101 CAR-T Cells in Patients with Relapsed/Refractory (r/r) Multiple Myeloma (MM)
Abstract 960 - Low Dose of Human scFv-Derived BCMA-Targeted CAR-T Cells Achieved Fast Response and High Complete Remission in Patients with Relapsed/Refractory Multiple Myeloma
Abstract 959 - Clinical Responses and Pharmacokinetics of MCARH171, a Human-Derived Bcma Targeted CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma: Final Results of a Phase I Clinical Trial

2b) Abstract 1011 - Fully Human Bcma Targeted Chimeric Antigen Receptor T Cells Administered in a Defined Composition Demonstrate Potency at Low Doses in Advanced Stage High Risk Multiple Myeloma
Defined CD4 CD8 composition BCMA CAR-T: Interesting idea. Not sure if there will be a real advantage. Need more data to decide.

3)  Abstract 1009 - Tandom Autologous Transplantation and Combined Infusion of CD19 and Bcma-Specific Chimeric Antigen Receptor T Cells for High Risk MM: Initial Safety and Efficacy Report from a Clinical Pilot Study
Combined CD19 - BCMA CAR-T: another interesting idea and may overcome some resistance pathways.

4) Abstract 1014 - Safety and Efficacy of Multiantigen-Targeted T Cells for Multiple Myeloma
Multi-antigen targeting CAR-T: one step further than dual CD 19 BCMA targeting CAR-T. Interesting and may be another way to overcome resistance

5) Abstract 591 - ALLO-715, an Allogeneic Bcma CAR T Therapy Possessing an Off-Switch for the Treatment of Multiple Myeloma
Allogeneic CAR-T - May fulfill potential of off the shelf CAR-T in future preclinical study

6) Abstract 590 - NKG2D-CAR Transduced Primary Natural Killer Cells Efficiently Target Multiple Myeloma Cells
CAR-NK: I guess this is CAR-Tish and can be included in this list!

7) Abstract 1013 - T Cells Expressing Anti B-Cell Maturation Antigen Chimeric Antigen Receptors for Plasma Cell Malignancies
There’s one more CAR-T abstract I found interesting but didn’t know whether it was a “2nd gen CAR-T” or a consecutive patient series with an existing CAR-T.


Thank You Dr. Rajkumar for your leadership in the patient fight to survive this deadly disease.

Another new treatment approach which is becoming more and more important is the use of Antibody Drug Conjugates(ADC).  I plan on providing a similar evaluation of this very important new treatment approach in my next ASH 2018 Myeloma Crowd article. 

Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1
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Multiple Myeloma 2018 Update - Why Do People Beat the Average Myeloma Life Expectancy Prognosis?  Or How To Improve Your Multiple Myeloma Survival Rate!

11/26/2018

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You Don't Know What
You Don't Know, Until
You Know It!

Greek Philosopher
Socrates

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A newer 2020 (with a COVID19 preface) version of this post can be viewed if you CLICK HERE!
I have updated this post several times, and it has been very helpful to many in the myeloma patient community.  I believe one key area which could have the greatest impact on patient survival is the improved dissemination of the myeloma specialist approved best treatments for each individual patient.  The 20% of myeloma patients who see a myeloma specialist or consult with one, are provided with the best current treatment knowledge, but this leaves the remaining 80% underserved.  How then do we make this happen?

One thing has become very clear to me, the pace of change and progress for myeloma has become exponential.   This is a very good thing!  We have had 5 drugs approved for myeloma since 2015 (two are new classes of drugs).  In addition, new targeted treatments like CAR T and ADC(Antibody Drug Conjugates) have exploded with just 3 myeloma CAR T ASH(American Society of Hematology) abstracts listed in 2009, and in 2018 ASH lists 104 myeloma CAR T abstracts or 35 times as many. 


As a patient advocate I find it nearly impossible to keep up with the avalanche of new data. I can not see how anyone but a skilled myeloma specialist can keep up to date with this rapid pace of change.   But Dr. Lonial, a world class myeloma specialist from Emory University, says it best: CLICK HERE to view his advice.

Most myeloma specialists, and most knowledgeable patients and advocates believe this to be critical.  However, even with the need for a specialist input so obvious, 80% of patients do not see a myeloma specialist or obtain their input for a treatment plan.  I have written about this in a blog post titled, "
The Myeloma Conundrum!  Myeloma Specialists Do Not Grow On Trees!"  What this highlights is myeloma specialists are already working at their maximum, so even if the 80% wanted to see a specialist, there is just not enough specialists to handle all of the patients.  The solution identified in this post is to put expert information and guidance into the hands of the local hematologists, oncologists, and patients will receive expert input and achieve much better outcomes.

Mayo Clinic has developed the mSmart program.  This program provides a template that doctors can follow to provide care outlined designed and developed by some of the very best minds in myeloma research and treatment.  You can go to the mSmart site if you CLICK HERE.   A sample of the information presented on the site is shown to the left.

Currently under development, Dr. Fonseca of Mayo, Phoenix and the Myeloma Crowd have put together what I would call the next step in the process to make expert advice individualized, and in a manner patients can use and understand.  It was designed by myeloma experts, myeloma patients and is called The Health Tree.   You can learn more about the program and find your best individualized treatment if you CLICK HERE.   Until there is a massive increase in the number of myeloma specialists, these two sources are your best bet for the underserved 80%.


In the last two years, the average life expectancy has gone from 4 years to 5.5. years, according to The SEER(Surveillance, Epidemiology, and End Results) data for multiple myeloma published in April of 2018 by the National Cancer Institute.  This is outstanding progress in that life expectancy had been stagnant at 4 years for 5 consecutive years.   Some patients beat the odds and live 10 to 20 years or more. When I was first diagnosed, the data for a person with dialysis-dependent kidney failure was just 3 months, and the average for myeloma patients overall was about 3 years. Now, I am beyond thankful to be a nearly 13 year survivor.   I believe there are three critical components to beating the odds: Part one is early diagnosis and treatment before end organ damage.  Part two is disease dependent, or the hand that you were dealt.  Part three is related to the level of care that is available to you.  For more information on survival rates and life expectancy CLICK HERE. 

Part 1 - Early Diagnosis and Treatment

If you are lucky enough to have a general practitioner who picks up high protein in the blood and finds the disease early while it is smoldering, or stage one, you have won the Myeloma Lottery.  Life expectancy of stage one disease is 3 times greater than if you have been found in stage three.  Treatment guidelines were published in November of 2014 with the express purpose of finding and treating the disease before it has progressed and  causes end organ failure.  A National Institute of health article states the intent of this clearly; "The concept of initiating therapy after end organ damage is analogous to initiating treatment after the development of metastatic cancer in solid tumors. Indeed, screening, early detection and intervention have played a large part in the major curative advances that have been achieved in solid tumors whereas metastatic cancer remains incurable in these same malignancies. It is, therefore, not surprising that MM remains incurable, in spite of all the advances in therapeutic interventions. Could it be because we are waiting too long – until metastatic myeloma occurs – to treat our patients? In such a condition, watchful waiting may actually be more harmful to the patient than early intervention."  To read the whole article CLICK HERE! If you are one of the lucky ones who are found in the early stages of active myeloma or smoldering myeloma, you will have the luxury of time to understand the treatment options, find a myeloma specialist (a must), and plan to confront your disease before permanent end organ damage.  Dr. Rajkumar of Mayo Clinic did a wonderful job of explaining  the new criteria for myeloma diagnosis, and you can read it if you CLICK HERE.  Dr. Irene Ghobrial is doing some great work to follow MGUS and smoldering stages of the disease, to  develop treatments to cure, or at least prevent end organ damage.  CLICK HERE to view a myeloma crowd interview with Dr. Ghobrial on the subject.  Just as a note, the country of Iceland is testing all of its adult population over 40 to screen for MGUS, Smoldering, and active myeloma.  They call it iStopMM, a clinical trial supported by the IMF(International Myeloma Foundation).  This is a future I pray we will all see where we could cost effectively find MM early and treat it before end organ damage.  CLICK HERE or HERE to learn more about iStopMM.

Unfortunately,  Myeloma UK has reported that 1 in 5 myeloma patients die within the first two months of diagnosis, and that it takes nearly a year from the first symptoms to diagnosis for 25% of newly diagnosed patients.  Dr. Morgan of UAMS said it best when he outlined his thoughts on the subject of awareness and delayed diagnosis. He believes the fact that it takes 3 to 6 months and more often 6 months from first symptoms to diagnosis is a bit of a scandal.   To make real inroads in the myeloma we need to get it diagnosed early before we have organ involvement.  We need to make family doctors and family practitioners more aware of the disease.  They should do M spike and light chain tests on patients.  This makes a lot of sense to Dr. Morgan.  It is really tragic when patients develop renal failure when awareness of myeloma by a General Practitioner might have allowed the patient to get a consult or treatment from a myeloma specialist.  A myeloma specialist is critical to a patient's long term care and survival.  It is a disease that does not come on overnight but is years in the making.  Patient organizations can make a difference.     He believes the future of Myeloma will be to get earlier diagnosis, safe treatments, chemo prevention strategy, regular screening for para protein, and early intervention. 

I have kidney damage, a good friend of mine has debilitating bone pain, others collapsed vertebrae, one suffers from a myeloma caused stroke, and many have died from delayed diagnosis.   All of which might have been prevented with a simple test of light chains and M spike costing under $150 without insurance, and no cost if covered by insurance and referred by a General Practitioner.  It is what could be!


Part 2 - Disease Dependent

Some people are just plain lucky and are given a form of myeloma that is not that aggressive.  In other words they have myeloma, but it happens to be smoldering myeloma.   This form of the disease can be present in the patient but not show any outward symptoms.  It can remain in this mode for 5, 10, or even 20 years.

The age of the patient is very important, in that you are 2 times more likely to survive if you were diagnosed at 49 years of age or less.  The average age of  the typical myeloma patient is 70.  You can read more on this subject if you CLICK HERE. 

Some people may have an active disease but do not have any of the negative prognostic indicators.  These indicators include, but are not limited to, deletion of chromosome 17p and  translocation of  4;14 or 14;16 or 14;20.  Your myeloma specialist will run the FISH test or other genetic tests like GEP(gene expression profiling) to determine if you have any of these negative prognostic indicators.  If you are considered high risk(15% of patients) , the life expectancy is less than half of the current average, or just 2 years.  You can read more about high risk multiple myeloma if you CLICK HERE. 

The sensitivity of the disease to treatment is also important.  My myeloma seemed to be very sensitive to the combination of Cytoxan, Thalamid and Dexamethasone, a treatment that put me into remission very quickly.  Some people might have the same experience with Revlimid, Velcade, or Dex, or any combination of these drugs.  If the disease comes back, as it often does, the re-application of the same regimen may continue to work for years.  I know one patient who has taken Thalomid for years as his only treatment and remains in remission. 

And of course if the average is 5.5 years, half of the people will invariably beat the average. 


Part 3  -  Quality of Care



There are some elements that you may or may not have much control over, the first of which is the availability of insurance.  If you do not have insurance or have no access to care, the average life expectancy is less than one year.  However, Medicare has a Compassionate Allowance Program where you can be approved in less than two weeks if you go to your local office and can show that you will not live without care.    To see the program CLICK HERE.  The Affordable Care Act may provide an option for the 15% who are not insured, and Medicare, Medicaid, and drug company assistance programs are also available. In addition, there are  other programs which can provide assistance  listed on the bottom of the home page, to view CLICK HERE.

Multiple Myeloma is a rare blood cancer, so many hematologist/oncologists may not see one patient in a year.  As a result not all oncologists or hematologists are the same. However, some are very skilled and experienced with Multiple Myeloma and have treated many myeloma patients. The data shows these myeloma specialists provide an average life expectancy of 10+ years or more, compared to the average which is at 5.5 years.

For a listing of these exceptional specialists CLICK HERE or for a more extensive list without survival history just CLICK HERE. I chose to get my 2 SCT(stem cell transplants) at University of Arkansas for Medical Sciences, UAMS, which has a myeloma program called MIRT, Myeloma Institute of Research and Therapy.  At the time they had over 10,000 transplants under their belt, and as a result they were expert at the process, and knew what could go wrong and had a plan in place to get you through any potential complications.   I have found from my work on this site that centers like Mayo, Dr. Hari(Medical College of Wisconsin),   UAMS, or Dr. Berenson's (IMBCR) have very different approaches to treatment, but because they are expert in what they do, they have similar results.   You would choose a brain surgeon over any other surgeon if you had a brain tumor, why would you not do the same for myeloma? Find out how to find a myeloma specialist by CLICKING HERE or CLICKING HERE. 

Myeloma specialists have access to drugs that other oncologists do not.  Because they are the thought leaders, they are involved in clinical trials, and can obtain some drugs through other programs that lesser known oncologists do not have access to. Worse yet, oncologists who are not myeloma specialists may not even know that some of these drugs even exist.  For example, some of the well connected specialists have access to drugs or treatments like CAR T, MILs, Venetoclax or
Selinexor  which are not approved  treatments. But these experts can get approval for initial therapy through clinical trials or other programs. Or some specialists can use drugs that are only approved for relapse or secondary therapy options (Daratumumab,  Ixazomib, Krypolis and Pomalyst), and obtain approval to use them for newly diagnosed patients.   They also have access to the best clinical trials like KRDD(Krypolis, Revlimid, Darzalex, & dexamethasone)   for first line therapy which provides a response in 100 percent of patients.    When you run out of options with the currently approved drugs, they can provide access to those that have done great in clinical trial, but are not currently available to the general public. Because you need a significant infrastructure to conduct clinical trials at your facility and they cost the facility $15,000 per patient, few local oncologists have access to clinical trials.  Sometimes it is who you know! 

Myeloma patients seldom die from myeloma, they die from the complications from myeloma.    The number one complication is pneumonia, and others include infections, kidney failure, anemia, etc.  This, therefore, brings me to the realization that supportive care for the treatment of the many complications of this disease may just be as important as the cancer treatment itself.  Or a great Defense(supportive care) is as important as the Offense(cancer therapy).   MD Anderson and Mayo Clinic emphasize supportive care in their programs, UAMS actually has a Director of Supportive Care in their myeloma program, Dr. Elias Anaissie, now a Medical Director at
Clinical Trial and Consulting Services (CTI).
  has an extensive background in supportive care.  Dr. Anaissie has published a well written example of an exceptional supportive care model. You can read this publication if you CLICK HERE. To read my blog post on supportive care CLICK HERE.

I also think the quality of care that you receive can be affected by the knowledge of the patient, and this can be obtained by doing your research on finding the best approaches to care by looking at the work of the best myeloma specialists on-line, and by going to great sites as listed in the Resource Section of www.myelomasurvival.com. To find out how to get educated about multiple myeloma  CLICK HERE.  In addition,  joining a support group of the International Myeloma Foundation or the LLS (Leukemia, Lymphoma, and Myeloma Society) will provide more great information to improve your life expectancy.  I have found that the average life expectancy of most of these support groups far out-performs the average. Knowledge is power!  Additional information on the benefits of support group membership can be found if you CLICK HERE. 

With 30,000 new cases of multiple myeloma in the USA, we can estimate the total number of patients in just the USA at 165,000. If we can move the average life expectancy from 5.5 years to 11 years by having myeloma specialists guide your care, we could save 165,000 times 5.5, or 907,500 years of LIFE.  Many times more if we include the entire world.  You all can help by getting this message out to the myeloma patient community through Facebook and Twitter. You may  know someone who has myeloma or  may have a friend or family member that can be helped by this information.  With your help we can "SAVE LIFE"!

Good luck and God Bless your Myeloma Journey/ [email protected]

For more information on multiple myeloma CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1


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Myeloma CURE Through Targeted Therapy!  It Is What Our Body Would Do If It Could!  ADC (Antibody Drug Conjugates)

10/19/2018

3 Comments

 
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     Myeloma - The Enemy

As I look over the myeloma treatment landscape, it is almost impossible not to be overly enthusiastic. In the beginning there was just Alkylating  agents, steroids and Stem Cell Transplant.   Then the novel drugs made the scene with Thalamid, Velcade,  followed by second generation proteasome inhibitors and imids, and finally monoclonal antibodies and CAR T(single target).  Now we are on the cusp of the last stages of development of many other new classes of drugs and treatments.  One or a combination of which, will be the silver bullet for those with late stage or high risk myeloma.  A  recent publication from Australia has studied more than 2 million cancer patients and have concluded the reduction in T cell production in the thymus gland reduces with age. CLICK HERE!  It is believed the reduced immune system status (reduced T cells) is no longer robust enough to keep the damage from carcinogens at bay.  It is therefore logical to bring the immune system back to a level where it can once again obtain the upper hand on the cancer!  Some of the newer techniques to achieve this immune system improvement are Bispecific CAR T, ADC(Antibody Drug Conjugates), AWC(Antibody Warhead Conjugates), MILS(Marrow Infiltrating Lymphocytes), and so very many more.

In a recent Cure Talks broadcast Dr. June, the father of CAR T, said it was no longer a matter of if, but a matter of when we will find a cure for myeloma and most cancers.  His point was with CAR T, it was just a matter of finding the right target antigen or combination of antigens on the surface of the cancerous cell and this would be the method to cure.  For myeloma he identified two antigens and is now conducting a trial for bi specific CAR T cells which have two targets.  So if some of the cells do not express one antigen, then it likely expresses the other and is still destroyed.  Combinations of CAR T expressing  BCMA, CD19, and CD38 are already in clinical trials or under consideration.  In addition there is work on many bispecific and even trispecific combinations.  CAR T has great potential with combination targets.

Another recent discovery has been  the use of monoclonal antibodies.  Daratumumab  has been an exciting new treatment with a single agent overall response rate of 29%.   However Glaxo Smith Kline has taken this one step further by attaching a toxin to their BCMA antibody.  This is called an ADC(Antibody Drug Conjugate).  This seems like a new development, however this concept  was proposed in 1913 by German physician and scientist Paul Ehrlich of the selective delivery of toxic agents to target cells causing disease.  An example of this concept for myeloma is the new drug GSK2857916 which now is in clinical trial.  The overall response rate for this drug as single agent was 60% or twice that of Daratumumab.  Not to be left behind Daratumumab has been turned into a AWC(Anitbody Warhead Conjugate) by the biotech company Actinium Pharmaceuticals, Inc.(ATNM)  This AWC showed a 10 fold improvement in myeloma cell death in vivo vs. Darzalex alone.  Finally, Takeda has a new CD38 antibody called TAK-079 and they are partnering with the biotech Molecular Templates(MTEM) to manufacture what they call a ETB(Engineered Toxin Bodies)
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ADC, AWC, & ETB all have one thing in common.  They have a Payload linked to the Antibody with a Linker.  The Antibody attaches to the cancer cell and the Payload and Antibody kills the cancer.


When we hear of drugs having twice to 10 times the killing power of any other single agent activity yet tested, we must be on the cusp of CURE.

If age related reduction in immune system function is a key to myeloma progression, then improvements in T cell function seems like a logical approach. In line with this premise is an interesting development at Johns Hopkins, spearheaded by the Dr. Ivan Borrello.  It is the use of MIL's.  MIL's (marrow infiltrating lymphocytes) are T cells which are in the bone marrow, and the body has mobilized them to fight the myeloma.  It is therefore thought expanding them and reentering a new larger T cell army to turn the tide back to the patient.  Dr. Borello states: ”The concept is that the bone marrow, in addition to being the site of the tumor is also a very unique immune site where it is a reservoir of memory antigen experienced T cells." 


Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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The Proof Capital Vultures Are Destroying Baby Bio Tech Companies Before They Have Time To Create New Drugs!

10/8/2018

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The Budget for the entire NCI (National Cancer Institute) is $5.74 billion.  This seems like a lot of money, but compared to the 609,000 patients who die of cancer each year and the estimated cost to bring one drug to market of as much as $2.5 billion, maybe not so much!  As noted in my last post,  small, micro, and nano tech companies are the ones who initiate the development of many of the new drugs.  Unfortunately these small vulnerable firms are under attack by ruthless Capital Vultures who attack and overpower these small company stocks through illegal MANIPULATION of their stock.  These Capital Vampires make huge profits at the expense of the small company's ability to stay in business by driving the stock price down and making it difficult to stay in business.   The greatest catastrophe is the millions of lives lost because cancer patients will never benefit from these potentially life saving cancer drugs.

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                                                CAPITAL VULTURES

The method used to manipulate stocks is called the short sale.  It is a concept where you sell shares of a stock of a company you do not own.  A broker will loan you the shares at a small cost and let you replace them in the future.   Either the broker must own the shares or have approval from owners of the shares.  I have owned stock most of my life, yet have never been asked to allow them to be shorted, and why would anybody loan out their  shares when the short sellers objective is to drive down the stocks value?  The very concept of selling something you do not own, just does not ring true!

Baby bio techs usually start out as an idea funded by grants to Universities, and once they prove to have potential, go public and sell stock to continue the funding for the years it takes to get a drug from the lab to the clinic.  They often do not make money for years until they show excellent results in Phase 2 and Phase 3 clinical trials.  At that point they are usually purchased by a large bio tech who will spend the billions to bring it to market.

So where is this evidence?  Stocks have risk and baby bio tech firms have more than most firms due to their very nature  As the saying goes, one expects more reward if you take on risk.  This should mean baby bio-techs on average should have a higher return because of their higher risk!   In the last 5 years the Dow Jones Industrial average is up more than 75%, so we should expect the group of micro tech companies ( those with a market value of between $50 and $300 million) to outperform the Dow and S& P.  Returns might be as much as twice that of the Dow, because the Dow has a very small risk compared to the micro bio-techs. 

The return for the average of all the micro tech cancer firms listed at: http://investsnips.com/list-of-publicly-traded-micro-cap-diversified-biotechnology-and-pharmaceutical-companies/ is not positive at all, nor even half of that for the Dow, but it is a  return of -55%.  Today's Market Value is a total of $12.3 billion for all of the micro bio techs listed and if the stocks had lost 55% of their value the Market Value should have been $27.2 billion without these Capital Attacks.  This is a loss of value of $14.9 billion or 2.6 times greater than the entire NCI budget.   Just think how they would have done if the companies would have grown another 75% just like the Dow.  Unlike most other non bio micro cap stocks, these companies if they fail result in LIVES LOST, and not just a bankruptcy. 

Elon Musk says short sellers are attacking his stock, and even though the Tesla Market Value is $43.1 Billion, it could be considered stock manipulation by short sellers if thery were also providing misinformation to drive the stock lower.  Greenlight Capital and Vilas Capital Management are both major short sellers of Tesla stock and will loose billions if the stock goes up.  They have been part of what many believe is a smear campaign of Tesla to drive the  stock price lower.  Articles CLICK HERE and HERE.  If the allegations by short sellers that 1)Tesla will lose more money on every new Model 3 sold or 2)Tesla is another Lehman Brothers are proved false, these short sellers should be prosecuted for criminal stock manipulation. 

I bring up  this example to explain how short sellers can impact companies like Tesla with a market value of $43.1 billion, just think how devastating a similar attack can impact a company with a market value of $50 million.  This is not a fair fight, but more like a slaughter.  The system is broken and must be changed to allow new cancer drugs to make it from the lab to the clinic.  Short selling  activity does not improve market liquidity, it just provides a cheap weapon for the Capital Vultures to crush the small and most vulnerable bio tech cancer companies.  How many Cancer Patients will these Capital Vultures KILL?

I have entered complaints to the SEC, FBI, and sent my feelings to many federal senators and  representatives and have not heard back from any of them.  There have been hundreds of complaints to the SEC, but the issue continues and now is worse because it means peoples lives.  Cancer will strike half of all people so if you are in a family of 4, 2 will get cancer.   Legislators are generally older and cancer generally affects these people with a much higher frequency, so do something to save yourselves and your family.  Stop this madness!

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What If The New Cancer Drug Pipeline Runs Dry? No New Cancer Drugs! Patients DIE!

8/30/2018

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For myeloma, and most cancers, new drug development has been a corner stone to improved survival and life expectancy.  To cancer patients it is the river of life, and we want to see it provide a torrent of new drugs.  But what if this river runs dry?

First the History of  New Novel Myeloma Drug Development


Just to let you know many, maybe most, new drugs are not developed by big pharma.  No, they start out as Micro Bio-Tech companies like Celgene was in 1997, when they opened a clinical trial to see If Thalamid  would have any efficacy for myeloma at the request of UAMS.  This unprofitable company, with $7 million in losses each year with a stock price of 50 cents and market value of just $8 million dollars was the genesis of the current company worth $65,000 million, and a stock price of nearly $100 per share.  The trial was successful, which led to Thalamid, Revlimid, and Polmalidomid.  

Taketa did not develop Velcade, it was the Micro Cap company ProScript - This led to Velcade, and Ninlaro

Amgen did not develop Kyprolis, it was the Micro Cap Onyx Pharmaceuticals. 

And the most recent example is the Micro Cap company, Karyopharm which has just obtained FDA approval for Selinexor

These drugs have saved so many lives and helped to double our life expectancy, and in the hands of a myeloma specialist has tripled it.  So what if these Baby Bio Techs were aborted before birth?   I believe I would not be here, and most patients would still be living an average of just 33 months.  This was the life expectancy before novel drug development.


I invest in stocks and have a COI in this area, I have recently invested about 2% of my 401k in Micro  Bio Techs.  I have far more 30% in the bio big boys, like Abbvie, Celgene, BIB. and XBI.  However, the most skin I have in this game is my LIFE, which depends on these drugs and new yet approved drugs.  In other words money means little to me if I am dead!

So OK, why does this have anything to do with new drug development?   These companies are started and funded by stock sales, they usually lose money in the 10 years it takes to bring a new drug to market, so investors are betting on the  idea and have FAITH it will come to market.  So when my 2 investments in Micro tech stocks tanked in a very short time, I was concerned.  I have senior level management experience, an Engineering background and MBA from NYU, so I know a little about stocks, balance sheets and  the P&L.  What I believe is happening is the micro bio tech stocks are being manipulated by predatory trading practices.  In early 2016 I noticed the volume of trades sometimes exceeded the stock that had been issued and the trading volume would go from an average of 1000 shares a day to 350,000 per day.  This was repeated over and over again for most of the Cancer Baby Bios.  This drove the stock price down and makes it far harder for these companies to survive for the time required to bring drugs to market.  Why?  If the stock has gone down 75% a company must sell 4 times as many shares to get the same cash to fund operations, not to mention that each investor has lost 75% or there investment, and investors lose confidence in micro bio techs.

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   The Cancer Drug Development River Must Never Dry Up From Predatory Stock Trading!


I believe traders and some brokers noticed the vulnerability of these stocks and overpowered them with illegal predatory trading practices, and it works because these stocks are based on faith.  And predatory trading can and does destroy faith in micro-cap bio tech stocks.  Most other small cap companies live and die based on the profitability of the company, and it is easy to see how profitable a company is,  making it far more difficult to attack successfully. 

As an investor, I could just cash out of these two bio techs and call it a lesson learned, and never again trade in micro cap stocks!  But as a cancer patient, I see the threat this kind of thinking and lack of faith will do to the very backbone of new drug development. If baby bio tech companies can not fund themselves through stock sales their products will never make it to market.  If Capital Vultures destroy the incubator of new drug development it will run the river of new cancer drugs dry causing a stagnation in cancer survival rates and life expectancy.  HOW MANY people must die because of a few morally bankrupt traders or brokers. 

The risk is we may not see many new drugs developed by these baby bio techs because they cannot survive the savage onslaught of these Capital Vultures.  I have put in a complaint into the SEC, and the FBI and hope they will work to stop this criminal activity.  How many people have to die because of this immoral activity.   You too can enter a complaint at the following links, SEC link:
https://www.sec.gov/tcr and the FBI link: https://www.tips.fbi.com  The more complaints the more likely of an investigation, and the sooner this activity stops!  Hopefully they will see some jail time, which should bring this activity to a halt.  Similar predatory trading practices resulted in the arrest of Taub and Shmalo who manipulated $10 Billion in stock. To read this case CLICK HERE.

A small sample of the baby bio techs which have been attacked include: ATNM, CGEN, CLRB, CTIC, KOOL, and KPTI (before excellent Phase 3 results), and to view an expanded list of cancer micro bio techs which are under attack or vulnerable to attack CLICK HERE.

You may be right I may be Crazy but it just may be a PREDATOR your looking for!  (A little change to Billy Joel’s lyrics)   Best Regards/Gary

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    Gary R. Petersen
    [email protected]
    CLICK HERE for my myeloma journey

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