Friday, April 21, 2023

The Magnificent Obsession of Mike Milken

If I asked you to pick one person who is most responsible for the remarkable progress we've seen in the cancer drug development arena in the last 25 years, who would you choose? 

Here are ten of my top candidates for that honor:

Jim Allison, the father of modern immunotherapy;  Carl H. June, one of the pioneers of CAR T-cell research;  Dennis Lo, who detected fetal cfDNA in the blood and introduced the first commercially available liquid biopsy assay;  and Steve Rosenberg, whose hard work led to the world’s first gene therapy that deployed the body’s immune system to fight cancer.

There are also Gwen Nichols, a renowned physician, researcher and chief medical officer at the Leukemia and Lymphoma who plays a critical role in advancing cures;  Michala Short, for her compassion toward patients as well as her work establishing Australia’s first proton therapy center;  and Mark Kaminski, the hematologist and researcher who co-developed Bexxar, a radio-immunotherapy that saved my life.  There are also Dr. Jian Zhou, the inventor of the cervical cancer vaccine;  Bert Vogelstein, the first scientist to explain the molecular basis of a common human cancer;  And Jennifer Doudna, whose work could make ultra-precise edits to DNA in cells and potentially cure cancer and more.

Those are ten of my personal heroes. But as much as I admire each of these men and women, there is one person who outshines even these bright stars. The Most Valuable Player in the cancer arena over the last three-plus decades is unquestionably Mike Milken. 
The more you learn about what he has done nationwide and worldwide, the more I think you will agree. 

Mike’s work in fact extends to all life-threatening diseases, not just cancer. In a recent WSJ op-ed (linked here), he refers to heart disease, polio, AIDS, Covid, infectious diseases, Alzheimer’s, hereditary conditions, and more.

But this story is focused on his work in the cancer world. And it is extraordinary. I generally avoid hackneyed descriptions like “larger than life” when describing someone in print. But Mike (he prefers Mike) really is. He's dramatically changed the cancer drug landscape. 

Mike is not a doctor. He is a financier, medical research innovator, cancer survivor, writer and devoted family man. And he has has somehow managed to bring the once-fractured cancer sector together. 

That includes pharma and biotech, academia, regulators, politicians, advocates, patients, all coming together in ways that we have never seen before. They are breaking bread and breaking the mold. Yes, it's still competitive. But the landscape has changed dramatically for the better thanks to Mike. 

The New Book Takes You Inside His World

Mike Milken
In his brilliant new book, Faster Cures: Accelerating the Future of Health, which you can purchase here, Mike takes us behind the curtain to show us just how he took on this enormous challenge. 
The book details the work he has done to get all the players in the cancer sector on the same page so that they can move cancer research forward. 
“It seemed crazy,” Mike writes. “These doctors held patients’ lives in their hands, yet they had an incomplete picture of the disease without the benefit of expertise from other institutions."

He goes on to say that the physicians and scientists at various elite centers viewed one another as competitors, not collaborators. “They were all drawing from the same small pool of grant money, and they were all trying to attract revenue-producing patients,” he writes.

“It reminded me of when I coached my kids’ soccer games. The biggest challenge was getting the youngsters to stay in position and cooperate as a team rather than everyone running to where the ball is. Too many medical researchers were running after the same scientific ball and not communicating with each other.”

Mike infiltrated the entrenched, isolated cancer "camps" and brought them together to expedite the development of lifesaving cancer modalities and get them to the public. His work has changed the world.

In the book, he shares personal stories about his childhood and what motivated him to become a global cancer warrior. The book works both as a ruminative autobiography (with co-writer Geoffrey Evans Moore) and a primer of how one man really can change an industry.

While many people are aware that Mike runs and hosts the Milken Institute, the nonprofit, nonpartisan think tank that helps people build meaningful lives, I'd guess that only a small handful of people know just how much he has done for the cancer community.

The Impossible Dream

Mike’s Quixotic dream of speeding up the process of drug development has been his mantra for 50 years. He's succeeded to the point where Fortune describes him as "the man who changed medicine." 

A pragmatic dreamer, he is a gentle but relentless advocate. He's very smart, and keenly aware that the only way to pursue this is to be non-partisan. But he has little patience for the way some research institutions act like sports teams carefully guarding their playbooks so their “opponents” won't know what they are  doing. Collaboration is the only way to move forward, he says.

It's hard to accurately quantify just how much he has given because there has been such an overwhelming ripple effect throughout the entire oncology world from his work. But thanks to Mike, even staunch and sometimes hostile competitors have come together. 

Cancer drug development is an arduous and expensive endeavor from the time a scientist has a notion in the lab to the clinical trial stages to FDA approval to manufacturing to marketing the product. But it's gotten much easer and more streamlined thanks to Mike. 


His mission actually started in the 1970’s with a few programs to advance drug development. But he knew there was so much more to do. As he writes in the book, he decided in the early 1990's that the cancer universe needed a complete overhaul. It was time to roll up the sleeves and get to work.

His resolve would lead to the formation of the Prostate Cancer Foundation, Melanoma Research Alliance, and ultimately FasterCures. By March 1993, Mike had come up with a new name for his organization: CaP CURE. 

The “Ca” stood for all cancers, he explains. The the “P” stood for prostate. And “CURE” was for all diseases. And he was inspired to fund young scientists. 
For nearly 50 years, Mike has advanced the careers of more than 600 early career researchers. “We call them young investigators, or YI’s,” Mike writes. “They work in two dozen countries."

Mike has connected with thousands of medical and scientific experts worldwide. 
He came up with this list of principles:

• Focus on the career paths of these young physicians.
• Focus on collaboration in place of competition.
• Build cross-sector ties.
• Identify the most promising research not funded by the National Institutes of Health (NIH).
• Eliminate needless bureaucracy.
• Relinquish intellectual property rights in exchange for speed and administrative costs.
• Supplement traditional therapies with proven alternative concepts. Generate public awareness.
• Educate members of Congress.
• Assure other disease groups that we were a resource, not a threat.
• Act with urgency.

These are just some of the organizations Mike has created. Each one is doing stellar work and is worthy of your support:

Milken Center for Advancing the American Dream (MCAAD)
The Milken Center for Advancing the American Dream believes anyone with a dream, and the drive to achieve it, should have the opportunity to make it come true— through expanding access to education, health, and economic freedom, and by unleashing the power of entrepreneurship and innovation.

Milken Institute
A non-profit, non-partisan economic think tank whose scholars lead an international dialogue on solutions in the areas of economics, health, aging, human capital, philanthropy and capital markets.

This Washington, D.C.-based think tank is removing barriers to progress against all life-threatening diseases.

Milken Family Foundation

Established in 1982, the Foundation is one of America's leading charitable organizations supporting education and a broad range of medical research.

Bioscience/Public Health
Major recent initiatives include the Milken Institute’s COVID-19 Treatment and Vaccine Tracker, and the biggest health initiative -- The Milken Institute School of Public Health.

Milken Scholars Program
The Milken Scholars Program provides outstanding high school students with a commitment of four years of college financial assistance, counseling, volunteer opportunities and preparation for graduate studies and beyond.

Melanoma Research Alliance

The MRA has awarded approximately $123 million to medical investigators in 18 countries focused on accelerating new therapeutic approaches for melanoma, improving existing treatments, developing new biomarkers and advancing understanding of risk factors. Since 2007, the FDA has approved 13 new melanoma treatments.

Prostate Cancer Foundation
The world's largest philanthropic source of funds for prostate cancer research, the Prostate Cancer Foundation is helping reduce the death rate from one of the most common cancers.

Other Non-Profit Activities
Mike's five decades of philanthropy include many other programs in medical research, public health and education.
Immunotherapy Has Come of Age
Meanwhile, it’s fitting and poetic that just as Mike’s book was released, Moderna and Merck announced the results of a Phase 2 clinical trial that combines Moderna’s personalized mRNA cancer vaccine and Merck’s blockbuster immunotherapy drug Keytruda for people with melanoma.

In the trial, which I wrote about this week for Healthline, the drug-vaccine combination reduced the risk of death or recurrence of melanoma, the most deadly type of skin cancer, by 44% compared with Merck’s immunotherapy Keytruda alone.

Several immunotherapies have made their way from the lab to the clinic, largely because of Mike’s support. Keytruda, for example, the checkpoint inhibitor, is now approved for more than a dozen types of cancer. I've written about Keytruda extensively.

And now the world is getting the first look at what can happen when you combine an immunotherapy with a personalized cancer vaccine. This is the future of cancer medicine, right here, right now. 

The next step of course is a Phase 3 trial, which could lead to a new option for people with melanoma. This is just the beginning of the cancer vaccine combination.
Moderna is of course the company that saved countless lives during the pandemic. 
Personalized medicine is just beginning to blossom. 

Throughout this magnificent obsession of Mike's, he has been consistent and unwavering. And to his credit, he has always been especially enamored of immunology. He is fascinated with the science of getting your own body to fight the cancer. 

Mike was convinced that this could be a game-changing medicine decades before the world began to open their eyes and minds to the idea that we have an immune system. I, too, was an early believer in immunology. 

From a young age, I instinctively believed that we all have an immune system. In late 1996, I was diagnosed with stage IV non-Hodgkin’s follicular lymphoma. My oncologist told me I would be lucky to live three years. But I had other plans. 

I was originally treated with a type of chemotherapy called CHOP. It was rough. It gave me a remission. But two and a half years later I was back in the trenches. 

This time, I took charge of my situation. First thing I did was get a new oncologist, who was much kinder and far more open-minded about my desire to enroll in a clinical trial. 
I looked far and wide for any and all potential treatments, including trials. I chose to enroll in a Phase 3 trial of a drug called Bexxar, a so-called radio-immunotherapy.
Bexxar was a monoclonal antibody linked with radioactive iodine I-131. Monoclonal antibodies are built to target and destroy only certain cells in the body. At the time, the drug, which was used to treat certain forms of non-Hodgkin's lymphoma, was usually given after other medications had been tried without successful treatment.

Bexxar not only put me back into remission and saved my life, it cured me. I have many friends who were also cured by that drug. But it was sadly shelved by Glaxo Smith Kline (GSK) for all the wrong reasons.

The drug company didn’t effectively market the drug and they clearly didn’t think it was going to be financially advantageous to continue offering this remarkable medicine. I was heartbroken with the drug was scrapped. Because it works.

GSK scientists have certainly done some very good things. But this decision was wrong on all kinds of levels. I have written extensively about Bexxar in Newsweek, where I proudly spent 23 years as a national correspondent, and International Business Times, and The Reno Dispatch news blog you are reading, and many other publications.

I still believe we should resurrect Bexxar and its sister medication, Zevalin, which is also a radio-immunotherapy that showed very good results with minimal side effects. These are both safe and effective medicines that were poorly marketed and underutilized. Perhaps they arrived too soon.
Thanks again, Mike

As a fellow cancer survivor, I thank you again for all you have done for the national and global cancer communities. If you ever need me for anything, please do not hesitate to ask.

Friday, April 7, 2023

EXCLUSIVE: Why Are Teen And Young Adult Cancer Patients Still Not Getting The Research And Support They Deserve?

When Allison Rosen (above) was diagnosed with colorectal cancer at age 32, it came as a complete shock. She had no idea someone her age could be diagnosed with this type of cancer, which most Americans still associate with people who are much older.

It was a daunting challenge for Rosen, physically and emotionally. But she bravely pushed on, endured treatment, and is now in remission.

Rosen, a trained scientist who worked for years in a lab, now works in cancer prevention and is a passionate advocate for her fellow adolescent and young adult cancer patients (AYA’s). 

“I believe there needs to be more research and more attention given to teens and young adults with cancer,” says Rosen.

“The physical as well as psychological aspects of being diagnosed with cancer just as your life is beginning can be devastating.” 

Rosen is intensely focused on increasing awareness of the unique challenges faced by adolescent cancer patients ages 15 to 39. And she’s not alone.

The idea is unambiguous: Teens and young adults too often get the short end of the stick when it comes to cancer care, and it has to change, for the sake of us all.

Why does this age group need and deserve more attention? There are multiple compelling reasons.

First of all, teens and young adults are diagnosed with cancer at later stages than any other sector of the population.

Teens and young adults are also the sector of cancer patients who are most often misdiagnosed. 

Teens and young adults also get by far the fewest research dollars thrown their way, the least amount of clinical trials, and the least amount of space in cancer hospitals.

The young adults age group is also the least likely to have health insurance. While kids and teens are typically covered under their parents’ insurance, young adults are often not covered. And many of them are just not even thinking about cancer or any other serious illness.

Teens and young adults also generally do not get tested for cancer. It’s simply not on their radar, or their doctor’s, if they have a doctor.

But the sad and chilling fact is that cancers in young people are alarmingly on the rise in America.

In a recent study of cancer trends among adolescents and young adults in the US, researchers reported a shocking 30 percent increase in cancer diagnoses among individuals fifteen to thirty-nine years old between 1973 and 2015. 

Despite the fact that cancer in AYA’s is alarmingly increasing, data on the epidemiology of cancer in AYAs are still inexcusably limited.

AYA’s Need Their Space

And lest we forget, there are the psycho-social aspects of being diagnosed in this age group, as well, and just where this age group is typically being treated. It’s insulting for someone who is 16 years old to be relegated to the pediatric cancer ward next to a very young child.

It is also unfair for for a 23-year-old cancer patient to be placed in the same treatment room as a person who is two or even three times his or her age.

Neither is optimal. Teens and young adults want and need their own space. A treatment environment that is age-appropriate is something every cancer patient wants and deserves.

Teen Cancer America (TCA) is addressing these needs. The non-profit organization works tirelessly every day to support adolescents and young adults with cancer, including establishing spaces in hospitals that are exclusively designed for this age group. 

Simon Davies, CEO of TCA, says that people of all ages need so support this sub-group of cancer patients.

“We need real change to improve the treatment experience, services, and research for this largely forgotten group of teenagers and young adults with cancer."

Roger Daltrey, legendary lead singer of the Who, is co-founder with his Who bandmate Pete Townshend of both Teen Cancer America and Teenage Cancer Trust in the UK. 

"AYA cancer awareness is the most important week of the US calendar,” Roger says. “We need everyone to understand the unique needs of young people with cancer and support these advocating charities in their vital work to save young lives."

Stupid Cancer Steps Up

Another leader in the AYA cancer coalition is Stupid Cancer, whose CEO, Alison Silberman, is proud that so many disparate organizations have come together for this age group.

Silberman says there is nothing but sincere collaboration going on here. “We all support each other. We all want the same thing,” she says.

The 411 on Teen and Young Adult Cancer

According to the American Cancer Society, approximately 90,000 people ages 15-39 are diagnosed with cancer each year.

Every hour in America, a young person between the ages of 13 and 25 is diagnosed with cancer.

Teens and young adults with cancer are usually treated in children's units (pediatrics) if they are teens or treatment with older people (medical oncology) if they are older young adults.

The average age for pediatrics is 6 and average age in adults is 60.

Entering high school or college, critical exams, career pathways, more significant relationships. These are just a few of the challenges of this age group. Cancer can disrupt and adversely affect all of these, sometimes causing irreparable damage. 

Peer groups are of course key at this age. Losing contact with friends and being treated where there are no other people of the same age is depressing and isolating. 

In some cancers affecting young people, such as bone cancer, there has been little progress or improvement in survival in 30 years.

Compare that to leukemia where survival has improved from 20% to 80%.

There has been a paucity of research and clinical trials in the AYA field. Their outcomes and survival have made inferior progress compared to older and younger populations.

This must change. 

Teens and young adults are old enough to know what is happening to them but often they are understandably not mature enough to cope with all of the unexpected and unwelcome changes and challenges.

It is not uncommon for a young person to protect his or her family from how distressed and frightened he or she may be.

Issues such as body image and loss of fertility are also complex and difficult things to navigate during cancer treatment.

Losing hair, fatigue, weight loss due to cancer or weight gain due to some treatments, surgery and scarring are all hugely important issues for a teenager who is just discovering his or her own identity.

A young person being told they may not be able to have children can have distressing long-term effects. The simple act of deciding when or how to tell a boyfriend or girlfriend that this is a possibility can be a harrowing experience.

Davies of Teen Cancer America says his organization plans to be an antidote to much of the above by developing specialized facilities, services and teams that will improve the treatment experience of young people, their outcomes and their survival. 

Teenagers and young people should be treated with people of their own age, Davies notes. Just as they are in schools, universities and youth groups. Even the criminal justice system treats teenagers differently.

The facilities that Teen Cancer America creates are vibrant, teen-friendly environments geared specifically to meet their needs. They are based on the successful model developed by Teenage Cancer Trust in the UK over the past 25 years and which are now a main stream part of cancer services over there.

These spaces can include social areas, kitchen/dining areas, computers, gaming systems, music systems and digital lighting. They may have pool tables and jukeboxes installed to create a strong youth centered environment. 

Having both facilities and expert teams in place at cancer hospitals will inevitably enable researchers to focus on this age group and study both the effect of the cancers on them and the effects of the treatments.

Teen Cancer America developed the first US specialized facility at UCLA. 

Some of the hospitals with whom Teen Cancer America is currently working are UCLA (CA), MSK (NYC), Yale (CT), Children’s Hospital of Philadelphia, Dana Faber (MA), Stanford (CA), Moffitt (FL), Baylor Scott and White, Fort Worth (TX), University of Chicago (IL), UH Hospitals/Seidman Cancer Center (OH), Duke (NC), UNC (NC), Children’s Hospital of Minnesota (MN) Lurie (IL) North Western (IL), UC Davis (CA), James (OH), and Nationwide (OH).

Allison Rosen Is Living Her Life


Allison Rosen during treatment
Meanwhile, the good news is that Allison Rosen is getting on with her life and continuing to inspire and inform her fellow cancer patients and survivors.

“I work in cancer research, and now in cancer prevention,” she says . “I was living my life, having a great time and not thinking I was on the clock to get married or have kids. When I was first diagnosed it was overwhelming. But there is help, and hope.”

Rosen asked her oncologist if there was another patient or group of patients around the same age that she could talk to for support at her hospital, MD Anderson. “I went to one support group, but it was older adults, and they just do not have the same needs,” she says. 

Rosen played an early role in the development of the AYA support group at MD Anderson.

“They did not have a young adult support group, so I brought that up in a meeting,” she said. “They took it from there and created a young adult support group. I am in remission, but still attend to this day.”

The simple message, Rosen says, is that you will need emotional support for rest of your life, people you can connect with.

“That support group saved my life,” she says. “I felt alone, I didn’t understand, and these perfect strangers have turned into some of my best friends.”