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If History Repeats Itself, The State of Myeloma New Drug Development Is STRONG! The Myeloma Miracle - Part 3

9/23/2019

If In the last 16 years multiple myeloma has had 10 drugs approved. All of these drugs have had two things in common, they all were awarded an FDA Orphan Drug(OD) designation, and secondly they all had one of the additional FDA designations of Fast Track, Breakthrough Therapy, Accelerated Approval, or Priority ReviewL. NO new drug has ever been approved for myeloma in 16 years without at least two of these FDA drug approvals. To be an orphan drug it must first affect no more than 200,000 patients in the US. The FDA's Office of Orphan Products Development is tasked to evaluate scientific and clinical data from companies to identify which therapies can improve the lives of people suffering from rare diseases. Orphan status is given to drugs and biologics defined as "those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders". The other destinations are designed to speed the availability of drugs that treat serious diseases, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments. The Food and Drug Administration has developed four distinct and successful approaches to making such drugs available as rapidly as possible:

Priority Review (PR)
Breakthrough Therapy (BT)
Accelerated Approval (AA)
Fast Track (FT)

A more in depth description of these additional designations and the advantages of getting them is available if you CLICK HERE.

Those drugs approved for use in mutiple myeloma in the last 16 years and the date of FDA approval for clinical use is as follows:

Velcade       2003          Pomalyst      2013           Ninlaro          2015

Revlimid    2006      Faradak       2015           Darzalex       2015

Doxil            2007            Empliciti       2015          Selinexor      2019

Kyprolis     2012

How can history repeat itself? First if we find what drugs which have at least two FDA designations but are not as yet approved by the FDA for clinical use, this just may be a very good list to see what the next FDA approvals likely will be. I count 7 drugs which have an orphan drug and one other FDA designation. For all of the drugs above which have been approved the average time from orphan drug designation to FDA clinical approval is 4 years, as compared to an average of 8 years without these two designations. A remarkable feat of twice as fast to market. Those 7 new drugs are with dual FDA designations are:

Drug                             Company                 Designations      Description

AMG420                        Amgen                        OD&FT          (BCMA) Bispecific T-Cell Engager
                                                                                                (BiTE®) Antibody Construct
CLR131                         Cellectar              OD&FT           Radiotherapeutic phospholipid drug
                                                                                                 conjugate (PDC™)
GSK2857916               GlaxoSmithKline           OD&BT          (BCMA) antibody-drug
                                                                                                 conjugate (ADC)
bb2121                          Celgene                       OD&BT          BCMA chimeric antigen receptor
                                                                                       CAR T
Galinpepimut-S              Sellas                      OD&FT          Immunotherapy vaccine to elicit a
                                                                                                 strong response against WT1
P-BCMA-101                 Poseida                     OD,FT&BT      Autologous chimeric antigen receptor
                                                                                                 (CAR) T-cell therapy
Melflufen                Oncopeptides            OD&AA         Drug activated by aminopeptidases,
                                                                                      overexpressed in myeloma

Many more drugs have an OD designation, but as yet have not received the second designation. So additional likely candidates could be added if and when they receive an additional designation by the FDA. This is remarkable when you consider the average orphan disease has less than one approved drug for each of the 6000 orphan diseases! If history repeats itself, I would argue we have a high probability of having 7 new drugs approved for the treatment of myeloma within 4 years or a rate almost 3 times that of the recent historic rate of myeloma drug development. This would be absolutely miraculous! I must thank the FDA with government support for putting in place the Orphan Drug Act, but again there is a synergistic magical sauce in the myeloma care community which has made myeloma a template for rare disease drug development. All the players in this community which includes the researchers, academics, myeloma specialists, patients, caregivers, patient advocates, large and small drug companies, supportive care teams, NCI, FDA, IMF, MMRF, LLS, Myeloma Crowd, and all those I may have left out, work in a talented cooperative team environment!

In this group of drugs are 6 new drug classes, and for each new class of drugs approved by the FDA we have had a 1 year increase in life expectancy. If history repeats itself, 6 new drugs would mean 6 more years of life expectancy for all myeloma patients or again double life expectancy, and 6 more steps towards THE CURE.

To read the prior two Myeloma Miracle posts click on PART1 or PART2. Good luck and God Bless your Cancer Journey/ editor@myelomasurvival.com For more information on multiple myeloma CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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The Multiple Myeloma Miracle (Part 2) - Does The FDA Have A Crystal Ball?

8/30/2019

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A recent study for drug development shows that only 1 in 10 drugs which enters into a clinical trial is approved by the FDA! The article states:

Washington, D.C. (January 9, 2014) – Today, Nature Biotechnology published a peer-reviewed paper co-authored by the Biotechnology Industry Organization (BIO) Industry Analysis and BioMedTracker (BMT) highlighting results of a study showing that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2011 is near one in 10. Previous reports, taken from earlier years, showed the rate of drug approvals is one in five to one in six.

Before Congress enacted the ODA (Orphan Disease Act) in 1983, only 38 drugs were approved in the USA specifically to treat orphan diseases. Which is just less than 6 drugs for every 1000 rare diseases. Now that is just appalling! But since this act was put in place another 503 drugs were approved for orphan drugs or 8 per 100 rare diseases, more than 10 times as many drugs. To become an approved orphan drug, a drug company must first apply for a "orphan drug designation", if they are approved for a designation, they receive many benefits, but must still go through the rigorous FDA approval process.

If we look at the most recent data and compare new orphan drug approvals by the FDA compared to the number of recent orphan drug designations, their success rate is 1 in 10, or very close to that for all cancers. This is a little different measure than the clinical trial numbers for all cancers because the designations are based on a FDA review of an application presented to the FDA by the drug companies, and many may not be in clinical trial. They are most likely not in clinical trial because the FDA provides a 50% tax break on all clinical trial costs, so why spend on clinical trials until you qualify for the rebate. The number of designations are therefore probably much greater than the orphan drugs on clinical trial. The likelihood is the actual approvals for drugs given an orphan drug designation that reaches clinical trial is much greater than are the ones based on the number designated as orphan drugs. Hope I did not lose you because I did not have access to the number of orphan drugs on clinical trial which made it to FDA approval, so I use the designations as a surrogate.   What is absolutely remarkable is drugs now designated as orphan drugs have the same probability of approval as do all drugs in clinical trial.

How does the FDA come into play on these outcomes? What about this crystal ball? And how does the Myeloma Miracle fare in this type of comparison?   The FDA requires an application process for a drug to be approved. The documentation is then reviewed by the FDA. When reviewing a request for orphan drug designation, FDA considers the mechanism of action of the drug to determine what distinct disease or condition the drug is intended to treat, diagnose or prevent. Whether a given medical condition constitutes a distinct disease or condition for the purpose of orphan-drug designation depends on a number of factors, assessed cumulatively, including: Pathogenesis of the disease or condition; course of the disease or condition; prognosis of the disease or condition; and resistance to treatment. These factors are analyzed in the context of the specific drug for which designation is requested. If the FDA approved the designation, they believe the drug to be a good candidate for the intended orphan disease, provide financial incentive, fast track the approval, and help the approval process with incite into what is required to obtain FDA approval. The FDA becomes an invaluable asset.

For myeloma the FDA seems to have a BIG SHINY and almost flawless crystal ball! The process of approval for drugs from designation as an orphan drug to FDA approval is 5 years, so if I look back at 2010 through 2014 designations I should be able to capture most of the approvals from 2015 through 2018. When I do this there were 21 designations for Myeloma and 9 approvals. This would be a 42% chance of an orphan drug designation for myeloma being approved by the FDA versus 10% for all drugs and for the recent experience for all orphan drugs.   Four times more likely to be approved than for any other drug!

What are the take a ways from this posting?

1) The FDA orphan drug designation process provides a significant improvement in the approval of all orphan drugs!   From 38 total orphan drugs to 548 total drugs.

2) Even with this improvement there is still just 548 orphan drugs for the 6000 orphan diseases. Less than 1 in 10 orphan diseases has an orphan disease specific drug. It means we must have many more orphan drug designation applications because 1 in 10 will get approved! More applications means more approved drugs.

3) The Myeloma Miracle continues with a total of 19 approved drugs! CLICK HERE.
To have 19 total drugs, myeloma must not only have 4 times advantage in approvals, but must have many more orphan drug designation applications entered. I become more astounded by the progress made by the Myeloma Treatment Community (researchers, myeloma specialists, patient advocates, drug companies large and small, caregivers, patients, FDA, NCI, IMF, MMRF, and Myeloma Crowd)

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

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The Myeloma Miracle - A Rare Success For a Rare Disease

8/21/2019

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In the United States the NIH (National Institute of Health) defines a rare or orphan disease as one which has fewer than 200,000 people. There is an estimated 6000 to 7000 rare diseases. I recently read a report about the success of the 1983 Rare Disease Act. It has been instrumental in bringing new drugs to market for Orphan Diseases. Prior to the law there had been limited to no success, and that is why this act was put in place to provide financial incentives for drug companies to pursue orphan drugs. Their success is obvious in the following graph.

Approvals of new orphan drugs went up from near zero each year to an average of 25 each year for the last 10 years. So in the last 10 years there have been around 253 new drugs approved for rare diseases in the US. This is exceptional progress and improvement, and can be explained by the financial incentives and the reduced time for approval of the rare disease designation by the FDA. But if you use the lower estimate of 6000 rare diseases, the average new drug approval per rare disease is .04 new drugs per rare cancer. Yes, that is just 4 new drugs for every 100 rare diseases. As you know each new drug has improved myeloma life expectancy, and in the last 10 years we have had 7 new drugs approved for myeloma! Myeloma has had 175 times the average drug approvals for rare diseases in the last 10 years.

In addition, we know that every new drug provides a longer life expectancy. In the last 10 years the National Cancer Institutes SEER data base has shown life expectancy for myeloma going up from 3 years to now 6 years or a 100% improvement. Miracle, or the secret sauce, of a dedicated and oh so talented group of researchers, myeloma specialists, myeloma organizations(IMF, MMRF, Myeloma Crowd, LLS), FDA, NCI, advocates, care givers, drug companies big and small, and care teams. I wish someone could bottle this secret sauce and make it available to the other 5999 rare diseases! We have been blessed with an abundance in new drug development.

One thing for certain is that if the life expectancy goes up by 100%, so does the cost to keep this chronic disease in check and the need for the next new drug until a cure is developed. Will we get the next new drug if there is little if any financial incentive for the drug manufactures? Based on the results of the Orphan Drug Act, incentives provide improved drug supply!

For now let's just celebrate our Myeloma Miracle, and hope and pray it continues until we find a cure, and quickly!

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

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Manipulation of the Stocks of Micro Cap Biotech Companies is KILLING Cancer Patients!

7/17/2019

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Capital Vultures Attacking Children, the Sick, and Frail! Just a MONEY Game to them! But LIFE OR DEATH to us!

Why do I care about this subject? I am a multiple myeloma patient, and have been kept alive through the development of innovation new drugs for the treatment of myeloma. Multiple Myeloma is an incurable cancer of the blood and has an average life expectancy of just 5 years. It is also a rare disease often called an orphan disease. Most of the innovations for this disease has their genesis from small bio tech companies (baby or micro cap biotech). I became interested in this issue because I follow all news on new myeloma drugs and the companies which are developing them. I also invested in some of them, and watched them closely. What I notice was even though a company put out a press release on a clinical trial showing good results, the stock price would go up, but then it will go back down lower than it started. Often in the same day. I am an engineer and have an MBA, so this made NO SENSE to me. Therefore I decided to do a little digging and uncovered some unnerving and frightening findings!

How on earth can the manipulation of stock impact the lives of cancer patients? If you look at how new drugs are developed, you will find many begin in academic teaching hospitals or through the support of NIH(National Institute of Health) grants to universities and start up bio techs. You can look on line and you will find different estimates from 42% to 100% of new drugs developed. CLICK HERE or CLICK HERE. The NCI(National Cancer Institutes) usually provides funding to those bio-techs which really show great potential, and also for those which focus on rare cancers like Triple Negative Breast Cancer, Rare Pediatric Cancers, High Risk and End Stage Myeloma, Mesothelioma, etc. The NCI has a focus on Rare Cancers because generally rare cancers do not have the numbers like Lung or Breast Cancer to interest the Large Biotech Companies. Twenty percent of all cancer patients have rare cancers, and have been under served. This shows up as a 5 year rate of death almost twice that of the most common cancers. However in Pediatric Cancers 72%, not 20%, of all cancers are rare cancers. CLICK HERE.

If these are rare diseases and do not represent a large number of patients then why should we worry about them? Well, each of these cancers may in itself be small in number, but together they represent 20% of all cancers or 350,890 rare cases each year in the USA. So if the baby bio tech are forced into bankruptcy,the drugs to treat these diseases will never make it to market. Therefore, the process for most new drug development collapses for rare, and for that matter all cancers!

I have explained the process of how and why these Capital Vultures raid these small vulnerable micro bio techs through the use of predatory attacks (short sales) of the baby biotech stocks. This drives down the price of the stock to near worthless levels forcing these companies into bankruptcy. You can read this explanation if you CLICK HERE and CLICK HERE. Without these companies we will have fewer and fewer new drugs and treatments, and more cancer patients WILL DIE.

I will give you just one of hundreds of examples. SELLAS Life Sciences (SLS) is a small biotech company who has had its capital base destroyed by these attacks. In just one year the stock has lost 92% of its value through these unlawful attacks. So to fund their clinical trials they must now issue 11 times more stock to obtain the same funds by selling stock. Maybe this is a bad company, and they deserve this valuation? This may be true if this company has not developed new drugs now in clinical trial which show excellent results in the undeserved cancers, Triple Negative Breast Cancer, Mesothelioma, and High Risk Myeloma.

The knowledge of this predatory activity is widespread, and has been debated for 20 years, but because it has only talked about the loss of capital it falls on deaf ears, or is justified as improving market liquidity. It does increase liquidity by stealing funds invested in these companies by NIH, retirement investments, and investors and poring it into the accounts of the Capital Vultures and out of the biotech companies. A complete though long explanation of this activity can be read if you CLICK HERE.

So much has been written about this, I am sure this will fall on deaf ears as well. We can only do our best to let people understand this is not just money. Money, like material things can be replaced, but when you are looking for the next line of treatment for your cancer and it does not exist because of greedy, heartless, criminal, morally corrupt, and probably rich Capital Vultures, these next new last chances for life drugs will not exist. Please help to give this the attention it demands of your government representatives, or you can do what I have done is to send twitter requests to some of the people who should be able to make a difference with a link to this blog post. Some twitter addresses of influential people are: @maziehirono @TNBC @JoeBiden @realDonaldTrump @RepJoeKennedy @SecAzar @SEC_Enforcement @SenateGOP @TheJusticeDept @FDACommissioner @FLOTUS @SenSanders @NIHFunding @HHSGov @RepCummings @BCAction @SpeakerPelosi @SenWarren @JusticeATR @NIH @DavidP4AD @Myeloma_Doc @USATODAYhealth @NYTHealth @SeemaCMS @mtmdphd @cure_talk @Myelomaauthor @US_FDA @FDAOncology @SagarLonialMD @Rfonsi1 @myelomadoc @VincentRK @TargetedOnc @AmericanCancer

I live in Florida, and sea turtles are endangered. They are endangered because they have been slaughtered for their eggs, meat, skin, and shells, and predators have found the nests as easy pickings. This has made sea turtles a protected species. In addition, the nests are found and fences are installed around them to prevent the nests from being raided by predators, and signs posted for humans stating messing with these nests is a crime! If we can protect turtles before they become extinct, why can't we protect micro cap biotech companies from the Capital Vulture predators, so endangered baby bio-techs do not go extinct. How many LIVES CAN BE SAVED?

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

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A Myeloma Patient's Guide To The Best Of ASCO 2019 By Dr. Joseph Mikhael

6/3/2019

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If you are like most of the myeloma patient community, you will not be attending the large conferences where the best myeloma specialists in the world congregate and discuss the current and future treatment options. So how do patients and caregivers find out about the best and most promising current and future treatments presented at these meeting? One way is to follow the action at the conferences through myeloma focused twitter, Facebook, and other online options. However, I have found that some people have a better perspective than most, and they are the myeloma specialists who attend these meetings.

So recently, Dr. Joseph Mikhael offered to provide a myeloma specialist's view on the best of the best for ASCO(American Society of Clinical Oncology) 2019. Dr. Michael is not just any myeloma specialist, but is the Chief Medical Officer of the International Myeloma Foundation. He is tasked to advance the mission of the IMF in research, education, advocacy and patient care to improve lives of patients with multiple myeloma.. The IMF is the oldest and highly respected patient focused myeloma support organization. Therefore Dr. Mikhael provides an invaluable perspective for the CURE TALKS myeloma broadcast of ASCO 2019.. The Broadcast is scheduled for 6/5/19 at 4PM EST. You can sign up for this broadcast and enter questions for Dr. Mikhael if you CLICK HERE!

Dr. Mikhael had provided a summary for ASH(American Society of Hemotology) 2018 which was just 6 months ago. ASH and ASCO are two of the largest conferences where myeloma has a significant representation. I have provided a 4 minute snip-it of his ASH experience, and you can expect a full hour of his expert opinion for ASCO19, and have the opportunity to ask your questions for the last 15 minutes.

Another myeloma specialist, Dr. Michael Thompson of Aurora Heath Care, Milwaukee provided an excellent summary of the best of the best abstracts of ASH 2018 last December. Prior to ASCO 2019 Dr. Thompson has provided a similar summary. If you would like to do some pre CURE TALKS research I am providing his excellent summary below.

If you might notice, even the experts do not have a unanimous consensus on any one abstract. So it will be very interesting to find out what the IMF Chief Medical Officer feels to be the most significant ASCO findings. Good luck and God Bless your Cancer Journey/ editor@myelomasurvival.com 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 Life Expectancy - The Good News And The NEW PROJECTION!

5/3/2019

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In April the National Cancer Institute published the SEER cancer statistics, and it showed myeloma life expectancy had improved from 5.5 years to 6 years. For the last few years I have been projecting the change in myeloma life expectancy. The National Cancer Institute's SEER data for myeloma patients can be found if you CLICK HERE. My estimate for last few years has been spot on. If you want to look at the history of these projections you can CLICK1, and CLICK2.

Below is a look at the history of the survival for myeloma in the USA and my prediction for the next 1 year improvement.

year                          survival milestones        years between milestones

1975              2 years                               -

1998                        3 years                             23

2004                        4 years                               6

2008         5 years                             4

2010          6 years                             2

2014(projection)        7 years                               4

The rate of change for myeloma improvement looks to have once again plateaued for a few years. The 5 year survival has remained nearly the same for the last 4 years, which does not bode well for a big move upward during those years. To really impact survival we must slow the high death rate in the first three years after diagnosis. With early testing with the Promise Study, the work with iStopMM, and early treatment for high risk smoldering myeloma, slowing early death may be achievable.

Another part of this is because a number of new drugs were approved in 2015, and the improvement for these drugs will not be represented in most of the current data published by the National Cancer Institute. But still if 35% of patients die in the first 3 years there is just 15% more to die to be at the median. Early detection is the key to significant improvements becoming a reality.

It is still a mystery to me why all the data provided by myeloma specialists show a 3 year survival in the 85 to 95% range and the SEER data for 3 years is just 65 to 66%. Which would mean you are 3.5 times more likely to die at the average SEER facility vs. at one of the centers with a myeloma specialist.

In addition, the likelihood of any improvement next year will be limited by a small backwards move in the 5 year survival as noted in the following graph.

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

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Help To Give End Stage Myeloma Patients A New Last Chance! HELP, We Need Everybody's HELP!

3/6/2019

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Cindy Chmielewski (or on twitter @MyelomaTeacher) does not give up easily. She is a Myeloma Patient Advocate and works tirelessly to provide assistance to the myeloma patient community. She was at the FDA advisory meeting which was to provide a nonbinding recommendation on the approval of Selinexor for end stage myeloma patients who have exhausted all available drugs. She and all myeloma patients, advocates,and myeloma specialists had recommended the FDA give these patients the opportunity to have access to the drug. I believe the draft document which was reviewed was quite negative, but all of the questions raised were answered by the myeloma patients, myeloma specialists, and advocates to their satisfaction. Selinexor has been given positive feedback by myeloma specialists almost universally, so the fact the approval was delayed for at least 2 years was heartbreaking. One interesting comment on twitter by the Patient Advocate Yelak Biru stated, "there is precedence where the FDA has approved Panobinistat despite negative vote from the independent ODAC committee. There may be a potential for them to do that as these cohort of patients really need an option." Cindy wrote the following request, and I will write the FDA, and pass it on to all of you to do the same. The panel was influenced because the drug can be used on a compassionate use basis, but the myeloma specialists made clear the 85% of patients being treated at community hematologists would not recieve Selinexor due to the lack of available necessary resources at community practices. Together we can SAVE LIFE!

Cindy Chmielewski
To:Myeloma community
Mar 6 at 10:02 AM

Hello My Friends,

Many of you were also disappointed in the outcome of the ODAC meeting on Selinexor. There is still time to voice your concern.

Below are the email and phone contact details for Ann Farrell and Nicole Gormley, who are leaders at FDA responsible for Hematology/Oncology drug approvals at FDA, should you or other advocates decide you would like to reach out. Feel free to share this with others.

Contact Information

Richard Pazdur, MD
Director, Oncology Center of Excellence
Acting Director Office of Hematology Oncology Products
301-796-2340
Richard.pazdur@fda.hhs.gov

Ann Farrell, MD
Director, Division Hematology Oncology Drug Products
301-796-1352
Ann.farrell@fda.hhs.gov

Nicole Gormley
Cross-Disciplinary Team Leader and Supervisory Physician
240-402-0210
Nicole.gormley@fda.hhs.gov

Thanks,

Cindy

Thank You Cindy and Yelak. Selinexor is a new class of drugs, and each new class of drugs has increased myeloma life expectancy by 20 to 25% from 3 years to nearly 6 years. The letter I emailed is below. Please feel free to use any part or all of it. We can make a difference.

Gary Petersen <grpetersen1@yahoo.com>
To:Richard.pazdur@fda.hhs.gov,Ann.farrell@fda.hhs.gov,Nicole.gormley@fda.hhs.gov
Cc:Jenny Ahlstrom,Cynthia Chmielewski,Fonseca, Rafael, M.D.,Richardson, Paul G.,M.D.,Saad Z. Usmani
Mar 7 at 10:12 AM
Myeloma patients who are at the end stage of the disease have NO current options other than clinical trials or if available' compassionate use. These options are only available at the larger academic centers and they treat just 15% of the total of all myeloma patients. The remaining 85% are treated in the community oncology setting. At the FDA's Oncology Drugs Advisory Committee (ODAC), the Myeloma Specialists at the meeting explained the lack of infrastructure at the community oncologist makes managing the compassionate use unlikely for the vast majority of end stage patients. Patients who get to the penta refractory end stage disease have shown an undeterred commitment to hanging on for the next treatment or cure. Clinical Trials like CAR T, ADC, and BiTE take time to enroll and are under great demand. Unfortunately patients are waiting and "Dying to get in!" The real deal is some of the patients with end stage myeloma were MRD negative after Selinexor, they won the myeloma lottery.

I am the editor@myelomasurvival.com and have followed this trial with the same excitement exhibited by the best Myeloma Specialists in the world. All the advocates, myeloma specialists, and patients I have talked to are despondent that your vote could be so different from that of the best myeloma specialists in the world. I think that experience, expertise, and understanding of myeloma experts was grossly underrepresented on the panel. If just two more myeloma specialists were on the panel, I believe the vote would have been 7 to 6 for expedited approval.

Jenny Ahstrom, the founder of http://www.MyelomaCrowd.org has written an objective review of the meeting and the frustration of the entire myeloma community, and you can view it at the link:

FDA Denies Early Access to Selinexor/Dex in Multiple Myeloma - The Myelo...FDA halts early access to selinexor/dex approval at briefing meeting. We need significant change in order to ide...

Please reconsider the value of all the myeloma experience represented by the myeloma specialists, myeloma advocates, patients, and caregivers who have all lived this disease and watch their patients, friends and family members die too soon. I PRAY you will please help us SAVE LIFE!

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Cancer Patients Beg For Help But The Government, Drug Companies, PBM's, and Insurance Companies Point Fingers While Patients DIE!

3/4/2019

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Only one copay program out of 7 is now open for myeloma and we are just through Feb. This is the real domino theory. Once one falls, it puts pressure on those that are open resulting in all of them closing in short order. Two years ago I wrote a blog post headlined Can You Hear It Now? The Jerry-rigged #Myeloma Safety Net Is Getting Shredded! when in March the co pay programs were running out of money. It got progressively worse for months. I had once thought this issue only applied to multiple myeloma with only 30,000 new patients each year. Myeloma is considered an orphan cancer which has gotten much less focus than other cancers like lung or breast cancer, which have 10 times more newly diagnosed than myeloma. However it is plain to see it affects most of the 1,735,000 cancer patients newly diagnosed each year. PANF(Patient Assistance Network Foundation) is one of the largest of the copay programs and provides assistance for 69 different diseases, but currently 51 are closed or out of funds. That is 74% of the total and it is just 2 months into the year. People depend on these programs and they have proved to be unreliable. Who would accept a 25% service level. No one! A short primer on how we got here!

- Medicare provided drug coverage for Medicare patients in 2006 - Good
- But to get it signed into law Drug Companies got a guarantee the price was a nonnegotiable list price - very bad
- Whenever foreign countries or PBM's for private insurance push net prices down (they can negotiate for lower prices) drug companies increased list price -very bad
- PBM's wanted higher rebates from drug companies because the drug companies list prices went up - very bad
- Medicare would not allow co pay for Medicare patients managed by the drug companies to get more generics used - misguided and deadly
- Insurance companies got lower net prices, but if the list was $100 and the net $50 they charge the copay % at list - very shady
- Prescription prices have increased over 100%(more for cancer drugs) since 2006 while inflation was less than 25%. - co pays went up more than 75% - very bad
- Drug companies funded third party co pay programs like LLS, PANF, PAF, etc to help patient afford their drugs - good for patients
- In 2017 drug companies underfunded the third party co pay programs, patients did not get drugs - patients died.

It got better in 2018, but we are now in what I will call "The Circle Of Death" because players(PBM's,Drug Co.,Govt, Insurance Co) game the system and patients lose. PANF has completed a survey of patients receiving co pay for the diseases they cover. Co Pay is critical to the health and well being of the patient. You can read it if you CLICK HERE. They note half of all patients skip doses prior to obtaining copay assistance, and with the high cost of cancer drugs it is most likely far greater. During cancer treatment this will reduce efficacy. The players are killing there customers and their cash flow!

It does seem to be a SNAFU! We need to change SNAFU to SWAP(Situation Wonderful All Patients). So what can be done to correct this SNAFU in the short and long term?

Short Term Solution( Fix the present system)

- Drug Companies MUST increase their contributions to the third party co pay assistance programs. All available myeloma drugs will be used in the course of myeloma and also for most late stage cancers, so ALL drug companies must BUCK UP!
- The government should allow drug company directed co pay programs if there is no generic or bio-similar available. This should achieve the same generic drug use but simplify the current convoluted process.

Long Term Solution(The permanent fix)

- You have heard a lot of the best ideas, let Medicare Negotiate Prices, PBM's negotiate a best price without rebates, have transparent pricing for drugs and healthcare services, provide a pricing review board for all patented drugs, have a maximum monthly total co pay limit of $100 to $150, etc. A very comprehensive review of what needs to be accomplished in the area of drug pricing is outlined in a document titled Addressing Out Of Control Prescription Drug Prices, Federal and State Strategies. To View CLICK HERE.

Until this safety net is repaired, patients will fall through the gaping holes in the net. The system had worked for those who found these assistance programs, but now these patients are at risk as well. I found out about the LLS program at an IMF support group meeting, and I, like most myeloma patients, had to stumble onto the programs. Cancer patients should be counseled on available assistance by the care team. At least a brochure headlined "Assistance for the High Cost of Care and Drugs". So it is time for the talking to stop and for Government to TAKE ACTION! I have likened this withholding of medication from the poor, disabled, and seniors as unintentional de facto GENOCIDE. With the recent congressional meetings and the testimony of families who have lost loved ones because of this SNAFU, it can no longer be considered unintentional!

Good luck and God Bless your Cancer Journey/ editor@myelomasurvival.com
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 2 - You Have Private Insurance Or No Insurance

2/11/2019

3 Comments

Myeloma 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

Amgen

Kyprolis
Amgen Assist 360 Program

Janssen

Darzalex
Janssen CarePath Program

Good luck and God Bless your Myeloma Journey/ editor@myelomasurvival.com
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

1 Comment

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

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