The Bridge To A Cure For Multiple #Myeloma!

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The American Society of Hemotology 2019 meeting may well be one of the most significant and productive ASH Conferences I have attended. Clinical trials using 4 drug combinations, and combinations with new drugs like Ventetoclax and Selinexor, and finally the clinical trials with CAR T, BiTE’s, ADC, and BCMA as a target all look to be part of the Bridge to a CURE!

From the patient’s perspective, it is always disappointing to see that the cure continues to escape us, but building new segments of the bridge to a cure is the second best possible outcome. What is the bridge to a cure? At two of the presentations I attended, Dr. Raji Vij of Washington University mentioned using combinations and the new drugs to bridge the patient to the next new treatment or a possible clinical trial. Dr. Sikander Ailawadhi of Mayo Clinic Jacksonville said the same thing about a drug he discussed called CLR131,(To view a Cure Talk 3/24 presentation on CLR131 CLICK HERE) and there was a poster on using SPd after failed CAR T as a bridge to the next clinical trial.

Although the cure is not apparent at this point, as long as we keep providing the next segment of the bridge we just may be able to live to see the CURE. In the past the segments of the bridge, even for breakthrough drugs like Daratumumab which had a ORR(overall response rate) of 24% with a PFS(progression free survival) of just 1.9 months, and Selinexor with a ORR of 26% and PFS of 3.7 months, improvements were marginal  and not overly significant. The new clinical trials like the ADC(Anitbody Drug Conjugate) GSK2857916 (Belantamab Mafodotin) in patients who had previously been treated with daratumumab, the ORR was 38.5%; with a PFS of 7.9 months, and finally the most seasoned CAR T study bb2121 shows ORR of 84% and PFS of 11.8 months. The point here is the ORR and PFS continue to improve giving those in the later stages of myeloma a bigger window to find the next treatment. The BiTE’s, ADC, and combination target CAR T(eg. BCMA and CD38) show even better initial results, but are just too early to call. 

Another key we have found is if a drug like Daratumumab works in the heavily pretreated patients, when we move it to earlier in the disease progression and in combination, we achieve outstanding results! Who would have thought a drug which had a PFS of 1.9 months would be the biggest hit at ASH19. It is being presented as a combination with everything and shows improved results. It seems all “ Things Go Better With Darzalex!” What happens when we move a treatment with PFS of 11.8 months to earlier in the disease progression? Will it be all “Things Go Better With bb2121, or BiTE’s, or ADC, or AWC, etc”? 

The momentum has shifted to the patient from the disease! The game is not over, the bridge is not built, but an end is in sight!

Good Luck and May God Bless OUR myeloma journey. For more information on multiple myeloma CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1


Affordable Access To American Healthcare  –  DEAL or BAD DEAL? Part 4 of 4

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I want to qualify this headline by first saying this has nothing to do with the quality of  health care services.  The doctors, researchers, hospital facilities and personnel, patient advocates and organizations, and drugs are of the highest quality in the world.  I have experienced this excellence with my own treatment of an incurable blood cancer called multiple myeloma.  I was blessed to have medical and drug coverage from my wife’s public school system union negotiated health care insurance, and secondary insurance of Medicare because the myeloma caused me to have end stage renal disease.  With these two insurances I was able to obtain treatment at Mayo Clinic and UAMS.   The prognosis for myeloma with  dialysis dependent  kidney failure was 3 MONTHS. Without access to this remarkable care provided by my excellent insurance coverage, I would not be alive 14 years later to write this post.  So I do feel blessed to  have this exceptional care, BUT for many of the  most vulnerable, seniors, poorly insured, and lower income patients’ this is not so!   This post is about Affordable Access to these outstanding life saving health care services.

We spend more on  healthcare than any other nation in the world.  In fact we spend at least twice as much per capita  than all but 4 countries in the world.   With this tremendous financial commitment we would expect to have some of the very best results in the world, at least in the top 10.   Two important measures of  a countries’ health care success are life expectancy and infant mortality rate-  The start and finish to life.  

The USA is ranked  46th in life expectancy CLICK HERE

The USA is ranked 54th in Infant Mortality  CLICK HERE

Apparently we are not getting what we pay for, or maybe we do get what we pay for.  To the extent the top 25% of income earners live for 87 years and the bottom 25% live just 77 years, maybe the graph below is not just a coincidence, but income dependent.  The best life expectancy in the world is Hong Kong at 85.29 years.  So money may not buy you love, but it may  buy you life!  High prices, under-insured, co-pays(medical and drugs), poverty, disability, retired, seniors, co-pays based on list not net pricing, PBMs, Medicare co-pays on drugs at list pricing always(no negotiation), insurance delay pays, etc..to  me we pay more than anyone in the world and do not get the outcomes we should expect. This is the Art of the BAD deal!


Another Part of the BAD deal is where we do not negotiate Medicare Part D drug prices, and as a result we do not get the net price from drug companies which most other developed countries negotiate.  These other countries negotiate a discount rate at  50% or more.  The USA buys more drugs than any other nation, and based on the economy of scale(buy more get a better price) we should be getting a price lower than any other country not twice what they pay!   Many countries therefore obtain drugs at half to a third of the price Medicare pays.  To see government study CLICK HERE.   Also, when drug companies increase the price by nearly 10% each year, the $ impact on these other countries is half of that which the USA will pay.   So if a list price is $100, the new Medicare cost would be $110, but for the counties which negotiate a 50% discount, their cost would originally be $100 x .5 or $50 and the new cost would be $110 x .5 or $55, a saving of $5 this time and every time a drug price goes  up..  In the President’s outline for drug price reform,he provided the following data from his plan. To see the plan CLICK HERE

Combined, Medicare and Medicaid represent 40 percent of the U.S. drug market – we’re the largest purchaser of prescription drugs in the world, and even if you just look at Medicare, it is clear that our spending is growing. In 2012, Medicare spent 17 percent of its total budget, or $109 billion, on prescription drugs. Five years later in 2017, this had increased to $185 billion. We’re talking about an increase of $76 billion in just five years.

Over the last five years drug list prices have gone up by 9.5% on average, and list  price increases represents $62 Billion of the $76 Billion increase in part D drug spending, or 82% of the total increase.  So not only do we pay twice as much as countries which negotiate drug prices,  but each price increase hits the USA twice as hard as for that of other countries.  To me that really sounds like “The Art Of The RAW Deal”.

To view the first three parts of this series CLICK HERE for Part 1, CLICK HERE for Part 2, and CLICK HERE for Part 3.

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

If We Take Away The Drug Companies’ Government FREE LUNCH, THE SKY WILL BE FALLING! Part 3 Of 4

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 Let’s set the stage by first establishing the logic behind not negotiating Medicare Drug prices.  The first is this will limit the development of fewer drugs because the drug companies will develop fewer drugs.  The other is that we will not have access to many of the current drugs for cancer which are currently available in the US but not in Europe or other countries.  Some very good arguments if they were at all credible.  But I would argue it is nothing more than Bogus Spin by Drug Companies and their lobbyists. The Drug Industries’ efforts to  Pettifog the Public!  I will talk about each of these points in detail. 

Before I begin the analysis of these arguments, I  believe they all are in fact mute.  If our government was a government which represented the people, one would think that if 9 out of 10 members of the public believe we should negotiate Medicare D prices, how on earth could  it not be law NOW? Something is very wrong with our democracy, when just 10% of the people can DICTATE policy! 

With all of this doom and gloom you would think the Medicare Part D was the vast amount of the global drug spending.  However, in 2017 Medicare Part D spending was just $154.9 Billion of the total worldwide spending of $1135.0 Billion.  This is 13.6% of the world spending.  The Congressional  Budget Office(CBO)  projects a savings of $49 billion per year and at the average after tax profits of Pharma at 14%,  the impact on the bottom line of the international drug industry would be $6.9 Billion or just 6/10 or 1% if I were to provide a liberal estimate of the impact to pharma.  Let’s just say, because we do not negotiate price the profit on Medicare is 3 times greater than the industry average or at 42%,  then the impact would be just 1.8%.  Someone seems to be trying to make a MOUNTAIN out of a molehill.  The source of much of this information can be seen if you CLICK HERE!  The CBO also estimates that the loss in revenue for drug manufacturers would lead to 8 to 15 fewer drugs coming to market over the next 10 years of the approximately 300 drugs expected to be approved during this period.  To me drug companies will continue to do what they have always done to improve profits and that is to JUST RAISE PRICE. With drug increases of over 10% each year for 5 years and 2017 at 8.4%, any impact of lost profits would be offset by just one year of price increases.

The final point on the suggestion negotiating price will limit the development of new drugs.   If you can make profits and your bonus by just raising the price of your existing drugs, why go though the heavy lifting to develop new drugs.  If we take away this FREE LUNCH, major drug companies will have a greater incentive to develop new drugs to achieve improved profits.  In addition, big pharma will more likely look to the small biotech companies who are a major incubator of drug development and help them to bring great ideas to the clinic.   The process used to be these small inventive companies would develop ideas conceived at Universities, the NCI,, Teaching Hospitals and Labs, bring them to a level of development and then be taken over or funded by large pharma which had the financial might to spend the $2.5 Billion to get these drugs to market.  This process has been disrupted when all you have to do is raise price to make bonus.  The inventive, small biotech companies now are starved for funding, and are seen as easy targets for destructive stock manipulation, which can and does bankrupt these small vulnerable agents of invention.

The last argument is just preposterous!  New drugs are patented so drug companies can sell them as a monopoly for several years.  For the European’s they set the price based on a value of $50,000 per year of life saved by a drug, and the US has a number from ICER which is a benchmark at $150,000 per year of life saved.  So the USA will always be the first country to get drugs approved based on having a much higher threshold for drug denial at 3  times that used  in Europe.  

Just as an aside, I recently attended the ASH(American Society of Hematology Meeting) in Orlando and was amazed at the explosion in new treatment developments.
With this new backlog of drugs in later stage development, the future of FDA new drug approvals looks outstanding. 

The last important part is the graying of America and the world, which provides a HUGE tail wind to the growth in Pharma sales and profits.  This has been reflected in the  tremendous growth which we have seen in Medicare Part B and Part D spending..  In 2017 spending was $185.3 Billion of the total USA spending of $333 Billion.  This was 56% of the total by just 15% of the US population over 65.  The US population over 65 will increase to 21%  of the US population in 10 years, 40% greater than today.  Logic would therefore assume Medicare spending would increase by 40% or $74 Billion without a price increase by Pharma due to just the aging population.  A way to reduce Medicare costs are right here, without cutting Medicare funding at all.  NEGOTIATE PRICE!

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


Mayo’s Myeloma And You: A Day For Patients And Caregivers

When Pat Killingsworth started Pat’s Myeloma Survival School he wanted to develop something which focused on the Patient and Caregiver.  He had attended many of the meetings like ASH and ASCO and found they were designed with a focus on the medical community, and lacked a patient focus.   At the time these sessions were held in the Jacksonville area so Mayo had a big part to play in them.  I got the same feeling at Mayo’s Myeloma And You Program as I had at Pat’s Survival School. This is why!  

–  The first 3 speakers were either patients of caregivers with lots of time for questions
–  Doctor Asher Canaan Khan and Dr. Sikander Ailwadhi have an uncanny way of providing a patient friendly presentation with humor
–   The second half of the program was all about supportive care
–  Dr. Mohamed Kharfan-Dabaja and Dr. Sikander Ailwadhi discussed the new CAR T program at Jacksonville, and the work they are doing with several malignancies including myeloma.
–  Dr. Ailwadhi discussed the many clinical trials which are currently available including AMG 701, BiTES, CAR T, ADC, Selinexor, and CLR 131.
–  Dr. Asher Chanan Khan discussed breakthroughs and Immunotherapy. He highlighted a new vaccine therapy which he feels just may be the BREAKTHROUGH for cure we have been hoping for.  Many vaccines have been tried and failed in the past but he feels he has finally found the key!  I hope he has, he is usually right!
​-  This Mayo Myeloma And You Program is just 2 years old and the growth has been exponential and the cost at $20 per person is a deal. Over 200 participants this year.  The drug companies like Takeda, Celgene, Sanofi, & Karyopharm helped to fund this program.  

Knowledge is power and for myeloma it is LIFE!  Thanks to all who helped to bring this patient and caregiver focused program to the myeloma patient population.  To me more should be presented using the Pat Killingsworth Survival School Template.

Good luck and may God Bless your families cancer journey. For more information on multiple myeloma CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

A few pictures from the meeting.

If USA Healthcare Was Affordably Accessible, The Very Sick Would Love Drug Companies, Insurance Companies, Government, And Medicare

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As a myeloma patient I feel blessed to have had great insurance through my wife who had great union benefits as a teachers aide.  I  had kidney failure so I could get Medicare coverage as a secondary insurance.  In addition this coverage allowed me to be treated at Mayo and UAMS, two of the world’s best Myeloma Centers.  So personally I loved my doctors, hospitals, and drug companies because I had AFFORDABLE ACCESS to excellent health care.  I, plus perhaps 50% of Americans, are equally blessed.  This leaves the remaining 50% without affordable access to our system, and this makes all the sense in the world why the following statements are true, and all else is bogus spin.

We spend twice as much as the highest per capita spending of any other nation in the world.  Over twice as much as the average of all other developed countries.  We should have a healthier population than the rest of the world, but over and over on any measure life expectancy, child death rate, etc. we are seldom even in the top 10.  We do not get what we PAY FOR !

Drug Prices are 2 to 10 times more  expensive than in most other counties.  All other nations and commercial insurance negotiates for lower prices, but Medicare does not.  It is like everyone gets to buy a car at half price except the US which must pay list!  Whatever drug companies give up to other great negotiators is made up by increasing list on Medicare!

Insurance companies, PBM’s and Medicare base copays as a percent of List price, and not of negotiated price.  If the insurer get a 50% discount you still pay the SAME % of List.  Also as the price of drugs increase the copay cost goes up.,  The copay for generic drugs is low $5 to $10 per prescription, but Tier 4 and specialty drugs(like cancer drugs) far greater and can be as much as 30 to 35% of the list price or as much as $5000 per per prescription.  The copays must be limited to $100 to $200 per prescription. 

Medicare Part B has no out of pocket maximum, so 20% or $500,000 for a stem cell transplant is HUGE!  A Medigap plan would be required at an additional $3000 to pick up this extra 20%. 

The new laws in the House and Senate do not address the issue of affordability, but could with some key modifications.  The following discusses most of the above and more.



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

Shouldn’t We Be Improving AFFORDABLE Access To Life Saving Drugs!  Most Else Is Just BS ( Bogus Spin)

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The major components of the new drug plans in the House focuses on Drug Pricing, and the Senate’s bill on pricing really does not even confront the Elephant in the room, which is the lack of negotiation of Medicare Drug Prices.  However, both bills have one thing which will improve ACCESS, which is the cap on out of pocket costs, the House at $2000 and the Senate at $3100.   So what is the Bogus Spin?  There are 3 major categories of BS (Bogus Spin)

– Reducing Negotiated Drug Prices will improve  AFFORDABLE ACCESS to life saving drugs.
– New Drug innovation will be stifled if Medicare negotiates price.
– We have the BEST health care system MONEY CAN BUY.

I had planned to do a three part YouTube broadcast on these three elements, but everyone was focused on other government business(impeachment).  I think it is only logical to start this series after the holidays.  However, I believe I can outline some of the logic beforehand.

Reducing Negotiated Drug Prices will improve AFFORDABLE ACCESS to life saving drugs.

Most private and government insurance (eg. Medicare, Medicaid) base the copay at a percentage of the List Price, not the Negotiated Price.  If the negotiated price goes down by 50% the list remains the same so the copay does not change one bit!  Copay must be changed to a percent of  net  pricing. 

The Insurance companies increase the copay % as the price of the drug goes up.  They call it Tiers, and I think they need to change the spelling to TEARS.  Tier 1 (preferred generic drugs)has a very reasonable copay of $5 to $15 per prescription, but in higher cost drugs in Tier 4 and the Specialty Drug Tier it is 25 to 33%  For cancer drugs this can represent $3000 to $5000 per month. I have myeloma and the one drug which is used in most all treatment regimens is Revlimid, at an out of pocket cost of $14,000 per year.  See the graph below.


 TAffordable is a major key to this entire argument.  Is it affordable to all Americans?  I say that is so much BS(Bogus Spin).  It is not affordable to most seniors, nor the middle class, the needy, and minorities.  Let me just talk for a minute about very sick seniors!  The ones with heart disease or cancer.  The number 1 and 2 killer of Americans.  According to the Kaiser Family Foundation the average income of a Medicare Beneficiary was $26,200 in 2016.  To be covered for the 20% copay of Part A & B, they would need to have Part G or F as well, and include Part D for drugs.  Cost for these insurance premiums is $5000 each year and with one drug like Revlimid at a copay of $14000, it comes to a total of $19000.  This is the equivalent to Senior Genocide, but with all cancers a slow agonizing death. Over 600,000 Americans die of Cancer each year!  Just for comparative purposes this contrasts to the costliest war in US history, the Civil War, where 620,000 soldiers died over a period of 4 years. 

New Drug innovation will be stifled if Medicare negotiates price.

If you were provided a free lunch everyday and it was excellent food, why on earth would you pay for your own?   Not having to negotiate price is the “ART OF THE NO DEAL”.   Drug companies must negotiate prices with all major industrialized nations, and private insurance companies and PBM’s(Pharmacy Benefit Managers), but for everything they lose in these negotiations can be made up by just raising list prices which Medicare will pay by law!

The NHS provides billions of dollar to fund the development of new drugs, and academic institutions provide basic research for drug development.  Frequently, this work is then developed by very small companies which do not have the capital to spend the billions to get FDA approval.  If they have a great idea, they usually are purchased or license  the drug to a large drug company, which has the funding to bring it to market.  The two blockbuster myeloma drugs, Thalidomide/Revlimid(Celgene)and  Velcade(Takeda) were developed by very small companies. Celgene was very small when it licensed the use of Thalidomide from Rockefeller University, and Velcade was first developed by a small biotech ProScript to treat muscle weakness and muscle loss associated with AIDS and muscular dystrophy and ultimately was purchased by Takeda.

To me the biggest barrier to new drug development is the lack of protections for small bio tech firms which have become the target of Illegal and criminal stock market manipulation.  Small companies can easily be forced into bankruptcy by Capital Vultures who have found easy prey in small and vulnerable biotech firms.  Many companies have been devalued by as much as 99% in just 5 years.  How many life saving drugs have not made it to market because of these heartless and morally bankrupt animals who feed off the dead and dying?  I explain this in a 3 part series and you can read it if you CLICK HERE.  Two prior blog posts on this major problem are as below, just click on either of the following story headings.

What If The New Cancer Drug Pipeline Runs Dry? No New Cancer Drugs! Patients DIE!
The Proof Capital Vultures Are Destroying Baby Bio Tech Companies Before They Have Time To Create New Drugs!

The USA has the BEST health care system MONEY CAN BUY.

This one is very hard to argue with unless we look at the definition of the word BEST.    If best is the one where you can get the best care in the world only IF you have all the money in the world, then it is hard to argue against this statement.  If best is defined by any other measure, best life expectancy, care for all citizens, care for the elderly and needy, most cost effective per citizen, non discriminatory, lowest infant mortality, ad infinitum, then we have a very long way to go. 

Each of these points will be discussed in my 3 part YouTube webcast titled “The Bogus Spin Report” or in short “The BS Report”. 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

BIG #MYELOMA NEWS WEEK!  #ASH19 Showed Excellent Progress Towards The CURE, & The House Passed A Drug Cost Control Bill!

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Myeloma Had An ASH Kicking In Orlando This Year!

I had an opportunity to attend the ASH(American  Society of Hematology) annual conference this year in Orlando from 12/6 to 12/10, and came away with the feeling the future of myeloma treatment is excellent!  These are my top line takeaways.

– Myeloma has a tight knit   community of researchers, myeloma specialists, patient advocates, drug companies, and myeloma organizations like the IMF, MMRF, LLS, and Myeloma Crowd.   They use Twitter and Facebook as communication tools which provides real time information to the myeloma patient community. There are more than 24 major categories of blood diseases represented at ASH, and  myeloma was frequently listed in the top 10 of ASH twittter online influencers.  Given myeloma is one of the the 24 major diseases, you would expect them to have less one top influencer in the top ten, but they had between 6 to 10 of the top 10.  Just remarkable!

–  Each new class of drug which is approved has resulted in an increase of one year in life expectancy.  We just had one new drug approved, Selinexor.   We also have 7 drugs which have a high probability of approval.  These are the ones with at least two FDA designations like Orphan Drug and Fast Track.  Effectively the ones the FDA finds  fill an unmet need and  have the most potential, kind of like the Teachers Pets of drugs.  CAR T, BiTE’s, ADC’s, AWC, melflufen, multi target CAR T, CLR131, allogeneic CAR T and many more, are all new classes of drugs which bodes well for current and future patients life expectancy.  I estimate a minimum of 6 new classes of drugs approved for myeloma which, if history repeats itself, would take the current NCI, national average life expectancy, for all patients from 6 years to 12 years.  The 15% who consult or see a myeloma specialist which now have a life expectancy of 10+ would likely see to exceed 16+ years.

–  When Daratumumab was approved in RRMM(Relapsed Refractory Myeloma) it had been approved  with an ORR(overall response rate) of 24% and a PFS of  just 1.9 months.  Daratumumab has been moving to early stages of the disease, and in combinations with EVERYTHING!  It seems “Things Go Better With DARA”!  These new combination with Darzalex are exhibiting exceptional resultsl. At this year’s ASH we have new drugs which have shown better initial results in heavily pretreated patients who have also failed Darzalex.  The newly approved Selinexor had an ORR of 26% and twice the PFS at 3.7months.  A drug in clinical trial, GSK2857916 has an ORR of 38.5% in  patients who had previously been treated with daratumumab, and a PFS of 7.9 months  This is 4 times more effective than the Darzalex PFS!  The big question is how will these and all the new classes of  drugs perform when moved to earlier in the disease process.  I think the sky is the limit!

– A big finding for me was a repeated use of the phrase “treatment used as a Bridge”.   At end stage myeloma, patients are often too sick to qualify for clinical trials.  If  treated with one of the end stage drugs like  Panobinistat, Selinexor, or many other combinations the disease may be able to be controlled enough to make it into available clinical trials. 

–  Treatments for early stage myeloma have shown excellent results,  For example high risk smoldering myeloma has a 50% chance of progressing to full blown myeloma each year, however an all oral clinical trial of IRd (Ninlaro, Revlimid, dex) had a 0% chance of progressing in the first 30 months or 2 1/2 years.  Many such trials for high risk smoldering myeloma are in process.  Soon the question will be how do we screen the population to catch myeloma in the precursor stages.  This may reduce or eliminate the devastating end organ damage associated with finding myeloma in the later stages of the disease progression.  The future looks bright!

The House Has Passed A Bill Which Should Help Patients To Get Access To Life Saving Drugs!  BUT!

This is great news for the myeloma patient community.  Cost is important, however the critical feature to the patient is ACCESS TO LIFE SAVING DRUGS!

The Congressional Budget Office estimates that the proposal would reduce Medicare drug costs by $500 billion over 10 years in three major ways:

· It would allow Medicare to directly negotiate prices for up to 250 of the mostly costly drugs that have no competition from generics or biosimilar drugs. Companies that don’t negotiate would be subject to an excise tax of up to 95 percent on gross sales.

·  The US prices of those drugs would be tied to a benchmark index of prices in other developed countries.

·  And, for all drugs, manufacturers would have to rebate back to Medicare any price increases that exceed the rate of inflation.

The most significant element of the bill for drug access is the capping of out of pocket and co pay for  Medicare at $2000 per year. Currently there is no out of pocket maximum limit.  Most all newly diagnosed myeloma patients usually have a treatment regimen including Revlimid, and the copay would be $2600 for the first month.  Under the House plan it would be limited to $2000.  Great news, if is was not for the fact 50% of prescriptions with a co pay over $2000 are abandoned at the pharmacy.  I believe Senate bill allows this to be spread across the entire year.  So what is the BUT?

The BUT is the house passed it on Party Lines, and  President Trump, who supported the idea of negotiating drug prices during his presidential campaign, now strongly opposes the House Democrats’ bill for part D.   The measure will likely die in the Senate, where Majority Leader Mitch McConnell (R-KY) may block it from ever coming to a vote. 

The Senate has a bill which the president will likely back BUT is absent one of his initial major objectives to negotiate Medicare, and Medicaid oral drug prices. This bill well likely be rejected if voted on in the House.   The concern in the Senate has to do with the thought this would limit new drug development.   Private insurance companies negotiate prices now, as do all single payer programs throughout the industrialized nations of the world.  It is also the talking point all the drug lobbyists are spinning!   It is known that 8 in 10 American’s feel Medicare should be able to negotiate drug prices.   BUT the measure does not address the problem copays are always computed as a percentage of the list price and should include provisions to make copays a percentage of the negotiated price. Under the existing system if the cost of a drug is negotiated down by 50% the copay would remain the same.  Our entire economy is based on negotiating price and trying to get a better deal by leveraging buying power or “The Art Of The Deal”.  The USA has 4.3% of the world’s population, but is estimated to be 45% of the world’s total prescription drug spending by Reuters in 2021.  As President Trump has noted the world gets a free ride.  Like China’s predatory trade practices, this must STOP!


This is a very complex problem which requires far more of a discussion than I can discuss here. I plan on providing a multi part You Tube broadcast which I will title “The BS Report”. 

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

Multiple Myeloma SPECIALIST List RESOURCES, Why is it Important to see a Specialist  By: Dana Holmes

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I can offer my opinion from a Smoldering Myeloma patient’s perspective as it relates to a Multiple Myeloma Specialist and what/why we recommend in our Smoldering Myeloma Support Group. There are “tiers” of specialists.

An MM specialist is a hematologist and likely also an oncologist who ONLY treats patients with MM. They DO NOT treat any other blood cancers/disorders (Leukemia/Lymphoma) or solid tumor cancers. The top tiered MM specialists are the ones who are conducting and publishing the research and are the Principal Investigators of the clinical trials offered to the MM community.

They are also the doctors who are presenting this data/research at their “industry” seminars and conferences, such as ASH (American Society of Hematology) and ASCO (American Society of Clinical Oncology), European Hematology Association (EHA) etc. Most are associated with large academic/university centers and cancer centers. Many are the Directors or Chiefs of their Departments and are members of the International Myeloma Working Group. IMWG members are the “governing” body of the International Myeloma Foundation. They are a group of over 200 top MM specialists from around the world…they convene annually to develop consensus guidelines which are disseminated to local hematology practices.

A general hematologist will treat ALL BLOOD disorders, including MM. A general oncologist will treat all cancers. Some of these doctors can be both hematologists and oncologists as well.

The overall outcomes for patients who are under the care of MM specialists are greater than for those who remain under the care of local community hematologists and oncologists. We highly recommend seeking at least a consult with an MM specialist and finding a local hematologist and/or oncologist who would be willing to partner with them to cover/monitor your care should you not be able to continue under the direct care of the MM specialist.

A recent study by the Mayo Clinic supported specialized care is the way to go. Read about this study in the Myeloma Crowd http://www.myelomacrowd.org/how-to-live-longer-with-multiple-myeloma/ as well as the formal study published in The Journal of Clinical Oncology: Association Between Treatment Facility Volume and Mortality of Patients With Multiple Myeloma http://ascopubs.org/doi/full/10.1200/JCO.2016.68.3805

If you want to determine if your particular doctor is conducting/publishing research, use this link. https://www.ncbi.nlm.nih.gov/pubmed/?term=Angela+Dispenzieri

Enter your doctors name along with “and Myeloma” in the search tool bar. This will bring up any research he/she has published and which has been peer reviewed.

This will work for any disease. If you want to check your physician’s research interest for MM or SMM (as an example) just link his/her name with that disease. You can try to use the term “and MGUS”, but you likely will not find much, as MGUS is part of a disease spectrum. Searching by the highest degree of a disease spectrum will likely yield search results.

If you don’t see anything listed, it is likely he/she is not actively engaged in research for this particular disease.

Do a second search and just enter the physican’s name. His/her research will be listed, and it will provide insight into their clinical interests.

Does this mean he/she is not a “good/great” doctor? No it does not mean that at all, but it infers your disease is not their primary focus. If they are not the researchers, at the very least, you want someone who attends their “industry” seminars and conferences to insure he/she is up to date on all of the emerging information. How do determine this? You ask them. Ask them what conferences they attend? You have every right to be an informed “consumer” of your healthcare. We all deserve the very best care. Many of us travel to get this level of care, as these types of top specialists are not found in great numbers.

Again, this is my opinion (but it is also opinion of many in the myeloma patient community).

MANY OF OUR GROUP MEMBERS HAVE LISTED THEIR MM SPECIALISTS IN THE COMMENT SECTION OF THE GROUP MEDICAL DISCLAIMER DOCUMENT …click on this link to review those comments https://www.facebook.com/notes/smoldering-multiple-myeloma-aka-smm/medical-disclaimer-for-smoldering-multiple-myeloma-aka-smm-facebook-group-est-12/1430234153886158

Our Member’s Multiple Myeloma Specialists Listing
https://www.facebook.com/notes/140081448349479/Our%20Member’s%20Multiple%20Myeloma%20Specialists./1784708618438708/

Why Should Myeloma Patients Visit a Specialty Center? – See more at: http://www.patientpower.info/video/why-should-myeloma-patients-visit-a-specialty-center#sthash.JgqNvYbc.dpuf

Multiple Myeloma Specialists and Hospitals or Treatment Centers ** http://myelomasurvival.com/myeloma-specialists-listing.html

** Please note.. Both of the lists provided in this link from Gary Petersen may contain the name of the Director or Chief of the Myeloma Specialty group only…it may not capture all of the specialists within that group…if you don’t find the name of “your” specialist on either of these lists, just try to determine if his/her Director or Chief is listed…this will assure you they are Myeloma/MGUS specialists and associated with the Director or Chief who is listed.

Multiple Myeloma 2017 Update – Why Do People Beat the Average Myeloma Life Expectancy Prognosis? Or How To Improve Your Multiple Myeloma Survival Rate!
http://myelomasurvival.com/myeloma-blog/multiple-myeloma-2017-update-why-do-people-beat-the-average-myeloma-life-expectancy-prognosis-or-how-to-improve-your-multiple-myeloma-survival-rate

Listen to the Myeloma Crowd radio interviews with many of the top myeloma specialists in the world (they provide transcripts if you prefer to read) >>> http://www.myelomacrowd.org/myeloma-crowd-radio/

Multiple Myeloma Research Foundation (MMRF) / Multiple Myeloma Research Consortium Member Institutions
http://themmrc.org/about/member-institutions/

Multiple Myeloma Research Foundation (MMRF) list of Myeloma specialists by state http://www.themmrf.org/living-with-multiple-myeloma/find-a-treatment-center/

The International Myeloma Foundation (IMF) / International Myeloma Working Group (IMWG) Members (Please note, although most members listed are hematologist/oncologists, some may be Radiologists or Metabolic Bone Disorder Specialists, as an example. Best to search their names to find their specialty ) (Also, please note, the IMF has not updated this list, some of these specialists have transferred to other Myeloma centers). http://imwg.myeloma.org/imwg-members/

A video from Dr. Brian Durie, Chairman of the International Myeloma Foundation (IMF) with advice how to locate a Myeloma specialist. https://www.youtube.com/watch?time_continue=12&v=weBGoq7YkYQ

Here is another resource to locate MM specialists (it has some outdated info it seems, doesn’t seem to have captured some moves/relocations, so be sure to double check the names you may find and want to consult with against some of the other lists or just by googling the specialists name to see where they are practicing now.) http://www.expertscape.com/ex/multiple+myeloma

Who’s Who @ the Mayo Clinic : List of MM Specialists http://msmart.org/

Here is a excerpt from a Myeloma Beacon Discussion (April 3, 2014) http://www.myelomabeacon.com/forum/centers-of-excellence-t3088-10.html and a link to Bone Marrow/Stem Cell Transplant Centers in the U.S.

Re: Multiple myeloma centers of excellence by

Dr. Edward Libby on Thu Apr 03, 2014 1:31 pm

Hello from gray (but warming up) Seattle,The following link is to US transplant centers that perform allogeneic stem cell transplants. Even though allo transplantation is not the standard transplant option for multiple myeloma I am posting this link because all allo transplant centers perform auto transplants as well. In general at these centers two out of three transplants are autologous transplants and the majority of autologous stem cell transplants are for multiple myeloma. Centers that perform both autologous and allogeneic transplant are going to be larger and busier. With a larger center that does more transplants there is generally going to be more experience andexpertise. http://bethematch.org/For-Patients-and-Families/Getting-a-transplant/Choosing-a-transplant-center/U-S–transplant-centers/

Types of Bone Marrow Transplants http://www.hopkinsmedicine.org/kimmel_cancer_center/centers/bone_marrow_transplant/types_transplants.html

Here is a good search tool to use to find the research interests of your MM specialists (type their name in the toolbar)
http://www.ncbi.nlm.nih.gov/pubmed/?term=ola+landgren


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

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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                         Celectar                      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 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, and 6 more steps towards THE CURE.

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


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

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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 sates:

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 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 drugs 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