The man behind the Musella Foundation

Today I would like to introduce you to Dr. Al Musella (Al), the man behind the Musella Foundation for Brain Tumor Research & Information, Inc. (a.k.a the Musella Foundation).  But first, I feel compelled to share a quick story about my original interactions with Al (and his foundation).

The year before my brain tumor was discovered, I was the executive director of a non-profit agency that supported students who would be the first in their families to go to college. Prior to that, I spent several years as a non-profit development professional/fundraiser and had the opportunity to create major gift programs for three different non-profit organizations that served some of the most economically disadvantaged communities in Los Angeles.  I never quite envisioned my career trajectory evolving the way it did. I was successful but also under constant stress.  All of that stress eventually wreaked havoc on my brain and body.  As a workaholic, I prided myself on taking very few sick days and was too busy working to stop and pay attention to the messages my body was sending me.  So, when everything came to a sudden and screeching halt–after the grand mal seizure that led to my brain cancer diagnosis–I was lost and depressed.  

I was used to working at a fast pace and constantly juggling several projects at the same time. For example, just a week before my diagnosis I was busy completing a newly designed Annual Report, firming up the agency’s first strategic plan, about to launch a newly designed website, overseeing multiple grant requests, meeting with funders, managing staff, preparing for year-end campaigns and events, directing programs, working with board members, and so forth. And, all of that while leading the agency through a projected six-figure deficit and into a surplus. I relied on my ability to relate to people and I used my voice to communicate on the phone and in meetings every day.  It was extremely difficult for me to go from all of that activity to basically nothing (well, unless you count recovering from brain surgery which really was my full-time job at that point). 

After my craniotomy, I struggled for a very long time. Yes, I had to relearn to walk, talk, and drive again but I needed to accomplish something too.  So, within a few months of my surgery, I started creating a children’s book with my son and a few colleagues. I wanted the book to raise money for brain tumor research.  Even though I could barely talk due to aphasia and halted speech, I reached out to Al and I shared my book idea with him.  Not only did he call me back, but he encouraged me to proceed. That encouragement meant everything to me at a time when I really needed it and I will never forget his kindness. Not only was he patient and understanding but he also took me seriously and that meant the world to me. Within a few months our book, “That Thing on My Mom’s Brain” was complete. I donated the book to the Musella Foundation where it was to be published.  Al never asked me to donate the book to his foundation, he actually offered to give me an ISBN so I could publish it myself, but I chose to give him the book because I wanted to make sure 100 percent of the net proceeds went toward the profound work he was doing. After it was published, one thing led to another and before we knew it the local papers were covering our story and the Port of Long Beach Employees’ Club was running a campaign to purchase several books for every Long Beach Public library (I think there were 12 at the time). We ended up raising thousands of dollars for the Musella Foundation and doing this allowed me to utilize the skills I had acquired as a non-profit development professional over the last few decades.   I had a reason to feel worthwhile during the time I was struggling most.  Having this success was the first step in regaining my confidence.  Al didn’t have to take my project on, he didn’t have to treat me with compassion and respect… but he did and that was the beginning of my new life. It was the start of my 2nd Chance 2 Live

So, what is the Musella Foundation for Brain Tumor Research & Information, Inc.,?

Here’s the short answer; the Musella Foundation for Brain Tumor Research & Information, Inc., is a 501(c)3 non-profit public charity dedicated to helping brain tumor patients through emotional and financial support, education, advocacy, and raising money for brain tumor research. 

Among other things, the Musella Foundation publishes “The Brain Tumor Guide for the Newly Diagnosed.”  My neurosurgeon gave me a copy of this book just before my craniotomy.  It was incredibly helpful and it was how the Musella Foundation was introduced into my universe.

Additionally, the Musella Foundation awards research grants click here for a complete listing of the grant recipients and offers copayment assistance for the most commonly used brain tumor treatments. Perhaps even more importantly, the Musella Foundation is on the front lines of advocating for the brain tumor community to have new, improved, and affordable treatment options.  The Musella Foundation also tracks clinical trials and moderates support groups.

Who is Al Musella?  The Interview:

Wendy:  Hello Al.  Thank you very much for taking the time to do this interview with me.  I am so pleased to have a platform where I can now share even more about the great work you are doing on behalf of the brain tumor community.  Speaking of the brain tumor community, what led to your deep involvement and commitment to help find a cure?

Al:  It all started back in 1992 when my wife’s sister was diagnosed with a Glioblastoma.  She had four young kids at the time and it was just not acceptable to us when they said there was no hope at all and she would be dead in less than a year. There was no Internet at that time (at least not the way we now know it). The NIH / NCI did not even have a list of all clinical trials back then! There was no Clinicaltrials.gov.  There were no online support groups dedicated to brain tumors, so I started the first one (in 1992) on Compuserve. The first thing I did was organize the members to create a database of treatment options. Then I set up a registry so we could track patients, their treatments, and the outcomes – so we could know which treatments worked best.  I called it the Brain Tumor Virtual Trial. When the first mainstream web browser came out in 1993, I set up the first website dedicated to brain tumors.  This website later became virtualtrials.com (and recently virtualtrials.org!). In 1999, the NIH / NCI noticed it and invited me to Washington to present it to their team that was building Clinicaltrials.gov. They modeled Clinicaltrials.gov off of the “Find a clinical trial” feature of my website!

“They [the NIH / NCI] modeled Clinicaltrials.gov off of the “Find a clinical trial” feature of my website!”

Then my dad was diagnosed with a Glioblastoma in 1999. Unfortunately, he quickly passed away.  My sister-in-law passed away exactly 20 years ago this week – after nearly a nine-year fight.

Wendy:  I am very sorry for the loss of your dad and sister-in-law.

Al: Thank you.

Wendy: I understand you are a retired podiatrist and that you worked your way through college as a computer programmer for medical research projects.  How have you utilized that experience to advance the mission of the Musella Foundation?

Al:  As a computer buff, as well as a doctor, I was able to bridge the gap between understanding what information was needed to speed up the search for a cure, as well as figuring out how to accomplish it.   It may seem like child’s play now to set up a website that takes a database of information that displays it nicely and makes it easy to search and use but back in those days it was incredibly difficult.

Wendy:  Oh, I get that. I still remember when the Internet first came out. I remember manually using DOS commands, having to use an external modem to connect, and a floppy disk to run the software (Procom) to enable the connection. But, now I’m just dating myself. Here’s an important question, how did you get into advocating for new laws and policies that benefit people with critical illnesses?   

Al:   My first significant advocacy win was 20 years ago.  Temodar was approved by the FDA at the same time my dad was diagnosed with a Glioblastoma.   He was one of the first people to get a prescription for it! However, when he went to get the prescription filled, he was told it would cost a lot of money, and his insurance (Medicare) didn’t cover it. His supplemental insurance had a yearly maximum of $1,000 a year on drugs – which was a drop in the bucket and already used up.   So he refused to pick up the prescription.   There were no assistance programs back then.  I had to lie and tell him I got free samples of it for him to take it.  So I investigated why it was not covered. It turned out that Medicare would have covered it if it was given by IV but not orally (at the time it was not available as an IV – that occurred years later).  I had meetings with Medicare and our senators. I set up our first major letter-writing campaign to try to force Medicare into paying for it. We argued that Temodar is actually a prodrug that gets converted in the body into DTIC which is a covered drug – and that it would be cheaper for Medicare to pay for the oral version than to require patients to go for infusions of the DTIC which wouldn’t be as effective.  We had thousands of people call and write Congress and Medicare, and we won!

We had thousands of people call and write Congress and Medicare, and we won!

My next campaign was for Gliadel.   Gliadel is a biodegradable wafer that is implanted into the brain at the time of surgery and slowly releases chemotherapy into the tumor bed.  This was a completely new concept so Medicare did not cover it – but in a sneaky way. They said the cost was bundled into the payment for the surgery.  So if a surgeon used Gliadel, Medicare paid the same as when they did not use it, and it cost about $10,000 back then.  Hospitals would actually lose money on every surgery. Many hospitals (I had a list of over 100 major hospitals) refused to allow its use. Doctors were put into a terrible situation – they were being told by their hospitals that they could not use it, but then had patients requesting its use. Surgeons had to discourage the use of it, even though it showed a benefit to patients.  We met with Medicare and our senators a few times, had another letter-writing campaign, and we won again! There was a new add on code created that made it so hospitals would not lose money if Gliadel was used. 

Wendy: Oh, the people running Medicare must love you, Al!

Al: The same type of thing happened when Optune was approved by the FDA.   Medicare refused to pay for it at first.   This time I had help. Another organization – the End Brain Cancer Initiative – worked with me. We had a few meetings with Medicare and almost had a quick win. Medicare agreed to pay for it. However, they priced it crazily.  They allowed so little money for it that it was impossible for the company to supply it at that price. To make it worse, that created a limiting charge so the company couldn’t even charge Medicare patients more than that price even if they wanted to pay for it – which usually would mean Medicare patients couldn’t get access to it but the company gave it to Medicare patients for free while we were fighting for it.  I was in the meeting where the finances were discussed and even Medicare agreed that the price charged for it was justified – but they just couldn’t pay for it.  So the company asked that Medicare remove the treatment from their formulary and we were back to square one.   We eventually got Medicare to have an open public meeting to discuss the issue of payment for Optune.  I was originally invited to be a voting member of the committee and participated in a few preliminary meetings. Then Medicare worried they would lose and decided to remove the doctors who supported Optune. They did this by instituting a rule right before the meeting that anyone who ever received more than $30 in cash or food from Novocure would be disqualified from participating in the meeting. This meant that any doctor who ever went to an education session where food was supplied was deemed “conflicted”.  This left only those doctors who never went to a presentation on Optune.  It backfired, as the panel had to read the research and make a decision on medical evidence grounds and it was obviously a good treatment – so the doctors who did not know about it and were against it at first learned about it and saw it was good.  So it got approved!

I also had some interesting interactions with the FDA.   When Avastin was being evaluated by the FDA for approval for brain tumors, the evidence was slim. It is a very good drug but at the time they did not really understand how best to use it – that came with time.  I testified at that meeting and presented the data from my virtual trial registry, which showed that for our patients, Avastin worked at least as good as what the trial showed and possibly a little better.  I think that helped it get approved.

When it was time for Optune to get approved for recurrent Glioblastoma, the data was also slim (it was much better for newly diagnosed).  I brought 12 Optune patients with me to the meeting who were doing well, and half of them testified that they wouldn’t be alive without the device. I testified with results from our virtual trial project and argued that the results were at least as good as standard treatments but without the side effects, which makes it a win for patients.

I did a similar thing for Gleolan when it was being evaluated by the FDA. I brought a few patients and a few neurosurgeons with me to testify. The FDA picked apart the design of the trial (which of course the FDA approved the design before the trial was started) and it was looking bad.  I argued that the experience in Europe was enough to approve it even without this trial and the patients and neurosurgeons told their stories and we won!

Wendy: Why fight for a treatment with a potentially small benefit?

Al: My thoughts on all of these treatments is that we need access to as many treatments as possible as the ultimate cure is going to be a combination of treatments, each of which alone will not be the cure. So the problem is getting them approved so we have access and we can try out the combinations! We also never really learned how to use the drugs until after they are approved.  When Temodar was first evaluated by the FDA for Glioblastoma, they rejected it saying the benefit did not outweigh the risk. Years after it was finally approved, we found that it works so much better when started at the same time as radiation instead of afterward. Same with Avastin – it almost did not get approval because of minimal increase in survival but after approval, we learned how to use it – and it became useful in many ways other than that used in the trials.  Same with Optune. The original FDA meeting saw no improvement in survival but we learned how to use it years later- to the point where it is now the best-approved treatment out there and we almost didn’t get it approved.

“…we need access to as many treatments as possible as the ultimate cure is going to be a combination of treatments, each of which alone will not be the cure.”

I had many private meetings with the FDA and some drug companies where I tried to voice my thoughts on why there was a need for quick access to their treatments and asked for a pilot study of a conditional approval pathway or at least a loosening of the accelerated approval standard, where we could get access to all of the promising experimental drugs, and the doctors could combine them to try to find the best combinations. A perfect example was a meeting we had for a vaccine that “failed” its clinical trial.  This vaccine was a simple shot in the arm with side effects that were no worse than that of a flu shot.  For the average patient, it made no change at all in survival so it was rejected and development stopped. However, digging deeper we saw about 20 percent of patients went on to do well for seven to 10 years and are still going strong.  There were subgroups that did exceedingly well.  We couldn’t get the FDA to understand the risk/benefit ratio of the vaccine and it was rejected.  It is absolutely insane that this vaccine is not available to patients now.

I asked specifically about making an exception to the accelerated approval standard and was told that I would have to get that law changed too. So I found a similar bill that died in congress a few years prior and contacted the senator (along with a few groups such as The Cure Starts Now and others) and asked if we could attempt to improve it and try again. The senator was willing so we hammered out a perfect bill. Unfortunately, a lot of other people had to work on it and they watered it down a little but it is still good. Senator Braun introduced the “Promising Pathway Act” into Congress a few months ago and we have been trying to push it ever since.  This bill would drastically speed up the search for the cure of not only brain tumors but all serious diseases such as ALS, Ovarian Cancer, and Pancreatic Cancer. It would change the way the research is done so most of the research is done after the approvals. The bar for approval is lowered to being shown that the treatment is safe and has the effect that it purports to have. For example, if it is supposed to block a growth signal, we would need to prove it does that, but not that it makes the patient live longer. The purpose of course is that blocking one pathway has been shown to almost never work (an exception is Gleevac in certain types of leukemia). However to craft the ultimate cure we need to figure out which pathways are driving the tumor, and which alternate pathways take over when we block the first pathways, and what happens when we block them all at the same time. This requires using drugs that by themselves do not improve survival. The key is that all patients using any drug approved in this manner have to be observed in a registry. This would allow doctors to search for similar patients, see what drugs they used, how it worked out, and then decide which ones to try. We learn by every patient’s experiences as we hone in on the cure.  This system also would quickly weed out bad drugs – as the doctors could see how bad a drug performs and would just not prescribe it – as opposed to our current system where bad drugs are being used for decades because we do not track the outcomes.

Please watch the video below to learn more about the “Promising Pathway Act.”

Wendy: How can the brain tumor community help to get the “Promising Pathway Act” passed?

Al:   To help, we all need to contact our representatives and educate them on why we need this bill and ask them to cosponsor it.  Go to Virtualtrials.org and click on Activism Alert for a quick and simple way to do that!

WendyWhat are you most proud of (both personally and professionally)? 

Al:  Professionally, there are two things that I am most proud of. First, is our Onc-201 expanded access program. This is an experimental drug for a very serious – invariably fatal – mostly pediatric and young adult tumor called DIPG and DMG. When early results were reported, patients clamored for it but access was hard. There were only a few small trials around the country with very limited openings. Most people couldn’t get it.  I had a history with the company that makes it – as I gave them one of their first research grants to develop it.  So I talked to them and asked if they could open an expanded access program. They said they did not have the resources to do it. I asked if we could do it if I ran the program and if I paid for it (as venture philanthropy – we get paid back only if the drug gets approved). They agreed and we did it – in collaboration with Cancer Commons and xCures (I am a founder and own a small part of xCures), The Cure Starts Now, the Michael Mosier Defeat DIPG Foundation, Dragon Master Foundation, and the Finn Family Foundation. We treated 120 kids and young adults who would not otherwise have a chance of getting this drug. It did not help everyone but there were some absolutely miraculous responses in a few. There were a few patients who started in wheelchairs and constant pain and had only a couple of months left to live, who over a year later were back to their old selves – playing, feeling good, going to (and doing well in) school and their tumors were continuing to shrink! Nothing makes me feel as good as when one of the mothers (or fathers) contacts me to update me on how good their child is doing. Of course, the opposite is also true – there’s nothing lower than being told a child is doing worse or died. I get attached to these people and it is always heartbreaking.

“Nothing makes me feel as good as when one of the mothers (or fathers) contacts me to update me on how good their child is doing.”

The other accomplishment is our copay program. I mentioned my dad’s problem with being able to pay for drugs. My sister-in-law also had a problem. She was on a drug for five years doing great when she hit her lifetime maximum benefit and the insurance stopped paying for the drug.  She stopped taking it and her next MRI showed a major recurrence and then she died. All because of an insurance issue.   I heard all of the time of patients not taking their medicines because of the expense. There were some copay assistance programs around but they were closed to new patients most of the time.  So I decided to start one. It was a very difficult process of getting the US Attorney General to allow my plan as there are laws against helping Medicare patients pay for drugs! But I did it. Then I had to raise money. It is difficult to raise money for brain tumor research – as it is relatively rare and most people never met someone with a brain tumor.  It is 10 times harder to raise money to pay for drugs for patients – as it only benefits the individuals who get a grant. But I managed to do it!  Every patient who qualifies (when we are accepting applications) gets a grant of up to $5,000 to be used for one year to help pay for the covered treatments. If they do not use it all in that year, any remaining funds get recycled into our copay fund to be used for others – or they can apply for another grant. We started in December of 2011 and so far have given out $7.4 million in grants, which helped almost 1,500 patients get access to treatments. Many of these patients tell us they wouldn’t have been able to get the treatments without us.

“It is difficult to raise money for brain tumor research – as it is relatively rare and most people never met someone with a brain tumor. “

Personally, I am proud of my family.  I have a wife and two sons.  My wife is a podiatrist like me.  My oldest son is also a podiatrist and he took over my practice so I could spend more time on the Foundation.  My youngest son is a lawyer, he wants to eventually take over the Foundation from me–he has some great ideas to advance the cause! And, if not for the Pandemic, he would have been getting married in November but now that is on hold.  All three of them volunteer with the Foundation. 

Wendy:  That is very interesting. I had no idea that you are a family of podiatrists. Hopefully, your youngest son and his future wife will have their dream wedding one day. Here’s another question for you…what is a “virtual trial” and why is it important that brain tumor survivors (especially long-term GBM survivors) sign up to be tracked by your virtual trials?

Al:  A virtual trial is a registry where we track what treatments you do and the outcome.  You register then come back once a month to tell us how you are doing.  You enter your height, weight, and Karnofsky score (a standard way of measuring your ability to perform ordinary tasks) along with any changes to medications, any new tests or procedures, and once in a while take the quality of life survey.  This also helps you by keeping your information organized – you can see how your quality of life or Karnofsky score is changing over time.  Sometimes a drop in either is a sign of the tumor recurring or an increase signals that your treatment is working.  We use the data to look for how different treatments are working. In this version we do not tell you what treatments to do – just observe what you and your doctor decide to try.

We have created a newer version that does offer treatment suggestions and collects more detailed information. It is a study called “A Patient-Centric Platform Trial for Precision Oncology.”  We have been in testing for almost two years and will be announcing it soon.

Wendy:  That’s incredible! How else can the brain tumor community (and others) help you in your efforts with the Musella Foundation?

Al:   The easy answer is to contact your representatives when I ask.  When I was at Medicare for the Gliadel problem, one of the Medicare people told me that his father had Gliadel implanted for his Glioblastoma and he would try to help me. He said the only thing that can change Medicare’s decision is political pressure. The medical reasoning won’t because they have a fixed amount of money and have to cut somewhere else if they add a new benefit. He went on to say that the brain tumor community has never been organized enough to apply enough pressure. I took that as a challenge and we succeeded!

And of course, donations are needed. This has been a slow year for donations as all of our fundraising events were canceled due to the pandemic.

Wendy:  You got it, Al! I did the letters to my representatives through your website in support of the “Promising Pathways Act” and it couldn’t have been easier (especially since your site identified who my representatives were and automatically generated the letters). I will also be making another donation to your foundation today and I invite others to join me in supporting the vital work you are doing. On a different note, what is something you can tell us about yourself that most people don’t already know?

Al: I love fishing and boating. As mentioned earlier, I get too involved with families going through brain tumors and feel the ups and downs of this rollercoaster ride.  I have been talking to a lot of people every day about brain tumors, for the last 27 years.  Sometimes it gets to me. Going out on the boat and fishing is a way to unwind. Without it, I would probably go crazy.

Wendy:  Is there anything else you would like to share right now?  Are there any other question(s) that I should be asking?

Al:  “The Promising Pathway Act” that I mentioned above is controversial. There are some organizations and people who do not support it. It will break the monopoly that drug companies have today and allow small companies to create new drugs at a cost of about five percent of what it cost today. That should drop the price of new drugs or at least hold the line on price increases. It should create new generations of drugs quickly which may make the old ones obsolete. This is great for everyone – except the people who depend on high drug prices and the current drug development system. Unfortunately, these people can spend a lot of money on lobbying. We can’t compete with money like that. What we can do is compete with the volume of people requesting their representatives to support it. This really does make a difference. We need a lot of people to apply pressure to counteract the lobbying.

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